http://www.metu.cn/index.php?qa=activity&qa_1=%E5%8F%82-%E6%AF%94-%E5%88%B6-%E5%89%82 Powered by Question2Answer http://www.metu.cn/index.php?qa=2179&qa_1=prudoxin-zonalon%EF%BC%8C%E5%A4%9A%E5%A1%9E%E5%B9%B3%E4%B9%B3%E8%86%8F-%E9%80%82%E7%94%A8%E4%BA%8E%E6%88%90%E4%BA%BA%E7%89%B9%E5%BA%94%E6%80%A7%E7%9A%AE%E7%82%8E%E6%88%96%E5%8D%95%E7%BA%AF%E8%8B%94%E8%97%93%E6%85%A2%E6%80%A7%E7%97%85%E6%82%A3%E8%80%85%E4%B8%AD%E5%BA%A6%E7%98%99%E7%97%92%E7%9A%84%E7%9F%AD%E6%9C%9F%EF%BC%88%E6%9C%80%E5%A4%9A8%E5%A4%A9%EF%BC%89%E7%AE%A1%E7%90%86&show=2183#c2183 普膚乳膏（Ichderm Cream），主要成分是doxepin（杜西平），是一種含抗組織胺、具有鎮靜作用的外用皮膚乳膏，主要用於治療濕疹性皮膚炎（如異位性皮膚炎、慢性苔癬）引起的中度搔癢，屬於短期使用藥品，使用時需薄塗患處、避免觸及眼睛及黏膜，且不建議連續使用超過8天，以免增加全身性吸收和副作用 参比制剂 http://www.metu.cn/index.php?qa=2179&qa_1=prudoxin-zonalon%EF%BC%8C%E5%A4%9A%E5%A1%9E%E5%B9%B3%E4%B9%B3%E8%86%8F-%E9%80%82%E7%94%A8%E4%BA%8E%E6%88%90%E4%BA%BA%E7%89%B9%E5%BA%94%E6%80%A7%E7%9A%AE%E7%82%8E%E6%88%96%E5%8D%95%E7%BA%AF%E8%8B%94%E8%97%93%E6%85%A2%E6%80%A7%E7%97%85%E6%82%A3%E8%80%85%E4%B8%AD%E5%BA%A6%E7%98%99%E7%97%92%E7%9A%84%E7%9F%AD%E6%9C%9F%EF%BC%88%E6%9C%80%E5%A4%9A8%E5%A4%A9%EF%BC%89%E7%AE%A1%E7%90%86&show=2183#c2183 Tue, 30 Dec 2025 14:25:09 +0000 http://www.metu.cn/index.php?qa=585&qa_1=%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E4%BB%80%E4%B9%88%E9%80%89%EF%BC%9F%E9%80%89%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E8%A6%81%E6%B3%A8%E6%84%8F%E9%82%A3%E4%BA%9B%EF%BC%9F%E4%BB%80%E4%B9%88%E6%98%AF%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%EF%BC%9F&show=585#q585 <p><span style="font-family:宋体,SimSun"><strong>1 什么是参比制剂？</strong></span></p><p></p><p><span style="font-family:宋体,SimSun">参比制剂是指用于仿制药质量和疗效一致性评价的对照药品，通常为被仿制的对象，如原研药品或国际公认的同种药物。参比制剂应为处方工艺合理、质量稳定、疗效确切的药品。</span></p><p><span style="font-family:宋体,SimSun">原研药品是指境内外首个获准上市，且具有完整和充分的安全性、有效性数据作为上市依据的药品。</span></p><p><span style="font-family:宋体,SimSun">国际公认的同种药物是指在欧盟、美国、日本获准上市并获得参比制剂地位的仿制药。</span></p><p><span style="font-family:宋体,SimSun"><strong>2 什么企业需要购买参比制剂？</strong></span></p><p><span style="font-family:宋体,SimSun">1） 仿制药生产企业与CRO公司</span></p><p><span style="font-family:宋体,SimSun">2） 仿制药研发机构与临床试验采购</span></p><p><span style="font-family:宋体,SimSun">评价对象包括：</span></p><p><span style="font-family:宋体,SimSun">国产仿制药、进口仿制药和原研药品地产化品种。</span></p><p><span style="font-family:宋体,SimSun"><strong>3 参比制剂购买流程</strong></span></p><p><span style="font-family:宋体,SimSun">1）参比制剂的选择与确定筛选与确认</span></p><p><span style="font-family:宋体,SimSun">2）参比制剂的备案与公布&nbsp; &nbsp;从这里搜</span><a rel="nofollow" href="https://www.136.org.cn/rld/">https://www.136.org.cn/rld/</a></p><p><span style="font-family:宋体,SimSun">3）申请《进口药品批件》</span></p><p><span style="font-family:宋体,SimSun">4）参比制剂采购&nbsp; &nbsp; 从主里询</span><a rel="nofollow" href="https://www.bwxm.net/">https://www.bwxm.net/</a></p><p><span style="font-family:宋体,SimSun">5）办理《进口药品通关单》</span></p><p><span style="font-family:宋体,SimSun">6）交税后放行，交货到客户</span></p> 参比制剂 http://www.metu.cn/index.php?qa=585&qa_1=%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E4%BB%80%E4%B9%88%E9%80%89%EF%BC%9F%E9%80%89%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E8%A6%81%E6%B3%A8%E6%84%8F%E9%82%A3%E4%BA%9B%EF%BC%9F%E4%BB%80%E4%B9%88%E6%98%AF%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%EF%BC%9F&show=585#q585 Sun, 30 Jul 2023 03:35:55 +0000 http://www.metu.cn/index.php?qa=995&qa_1=%E5%B8%83%E6%B4%9B%E8%8A%AC%E7%89%87-%E5%B8%83%E6%B4%9B%E8%8A%AC%E8%83%B6%E5%9B%8A%EF%BC%8C%E5%B8%83%E6%B4%9B%E8%8A%AC%E6%B7%B7%E6%82%AC%E6%B6%B2%EF%BC%88%E5%84%BF%E7%AB%A5%EF%BC%89%E5%85%A8%E7%90%83%E7%89%88%E6%9C%AC%E4%B8%8E%E5%8E%9F%E7%A0%94&show=995#q995 <p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=14078464800994538706" style="height:383px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=6111145685386118515" style="height:325px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=11335901098520107886" style="height:273px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=8602336385710904405" style="height:266px; width:600px">布洛芬（Ibuprofen）为解热镇痛类，非甾体抗炎药。本品通过抑制环氧化酶，减少前列腺素的合成，产生镇痛、抗炎作用；通过下丘脑体温调节中枢而起解热作用。</p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=2974614718809235612" style="height:316px; width:412px"></p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=12137340494276072931" style="height:271px; width:505px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=11555172002773273632" style="height:208px; width:467px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=7741370143729481896" style="height:272px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=1709664444052923993" style="height:332px; width:600px"></p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=13240157847311279874" style="height:332px; width:600px"></p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=15752326344242744459" style="height:294px; width:600px">美国美林</p><p></p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=7066515058492856057" style="height:800px; width:600px">英国产以色列上市的 布洛芬混悬液（儿童）</p><p></p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=3206516261296203148" style="height:600px; width:600px">美国辉瑞与GSK的布洛芬混悬液（儿童）</p><p></p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=10245993447450653357" style="height:600px; width:600px"></p> 参比制剂 http://www.metu.cn/index.php?qa=995&qa_1=%E5%B8%83%E6%B4%9B%E8%8A%AC%E7%89%87-%E5%B8%83%E6%B4%9B%E8%8A%AC%E8%83%B6%E5%9B%8A%EF%BC%8C%E5%B8%83%E6%B4%9B%E8%8A%AC%E6%B7%B7%E6%82%AC%E6%B6%B2%EF%BC%88%E5%84%BF%E7%AB%A5%EF%BC%89%E5%85%A8%E7%90%83%E7%89%88%E6%9C%AC%E4%B8%8E%E5%8E%9F%E7%A0%94&show=995#q995 Wed, 28 Dec 2022 04:14:33 +0000 http://www.metu.cn/index.php?qa=993&qa_1=%E5%AF%B9%E4%B9%99%E9%85%B0%E6%B0%A8%E5%9F%BA%E9%85%9A%E7%89%87-%E5%85%A8%E7%90%83%E7%89%88%E6%9C%AC%E4%B8%8E%E5%8E%9F%E7%A0%94&show=996#a996 <p>对乙酰氨基酚片</p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=14245545435558749197" style="height:280px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=3162968550413278769" style="height:457px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=2856479859470301117" style="height:274px; width:600px"><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=4143123393139146630" style="height:266px; width:600px"></p><p></p><p></p><p>欧盟波兰的对乙酰氨基酚混悬液</p><p><img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=14438369653623849817" style="height:516px; width:600px"></p> 参比制剂 http://www.metu.cn/index.php?qa=993&qa_1=%E5%AF%B9%E4%B9%99%E9%85%B0%E6%B0%A8%E5%9F%BA%E9%85%9A%E7%89%87-%E5%85%A8%E7%90%83%E7%89%88%E6%9C%AC%E4%B8%8E%E5%8E%9F%E7%A0%94&show=996#a996 Tue, 27 Dec 2022 07:29:10 +0000 http://www.metu.cn/index.php?qa=709&qa_1=%E6%8B%89%E8%84%B1%E7%BB%B4%E4%BA%9A%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E5%BA%93%E5%AD%98%E4%BF%A1%E6%81%AF&show=762#c762 Product<br /> Aerius sirop 150ml<br /> Aldara cremă 5% 250mg N12<br /> Azopt pic.oft.susp.10mg/ml 5ml N1<br /> Buscopan sol.inj.20mg/ml 1ml N6<br /> Cellcept comp.500mg N10x5<br /> Diovan comp.160mg N14<br /> Diovan comp.80mg N14<br /> Dostinex comp.0,5mg N8<br /> Flixonase Aqueous Nasal Spray 50mcg 120doze<br /> Tamiflu caps.75mg N10<br /> Dysport 500<br /> Dysport 300<br /> VISTABEL, 4SU/0,1ML INJ PLV SOL 1X50SU 参比制剂 http://www.metu.cn/index.php?qa=709&qa_1=%E6%8B%89%E8%84%B1%E7%BB%B4%E4%BA%9A%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E5%BA%93%E5%AD%98%E4%BF%A1%E6%81%AF&show=762#c762 Wed, 19 May 2021 07:44:22 +0000 http://www.metu.cn/index.php?qa=415&qa_1=%E6%B3%A2%E5%85%B0%E7%9A%84%E8%8D%AF%E5%93%81%E5%BA%93%E5%AD%98%EF%BC%88%E5%9C%A8%E6%B3%A2%E5%85%B0%E8%8D%AF%E5%93%81%E5%90%88%E8%A7%84%E7%9A%84%E5%BA%93%E6%88%BF%EF%BC%89%E7%8E%B0%E8%B4%A7&show=761#a761 <div style="color: rgb(0, 0, 0); font-family: &quot;lucida Grande&quot;, Verdana, &quot;Microsoft YaHei&quot;; font-size: 14px;">的<span style="font-family:georgia,serif">Propofol 10mg/ml sol.f. inj./inf. 20ml vial N5，</span></div><div style="color: rgb(0, 0, 0); font-family: &quot;lucida Grande&quot;, Verdana, &quot;Microsoft YaHei&quot;; font-size: 14px;"><span style="font-family:georgia, serif; line-height:23.8px">4000盒batch A0D1169A exp&nbsp;<span style="border-bottom:1px dashed #cccccc">2022-10-31</span></span></div><div style="color: rgb(0, 0, 0); font-family: &quot;lucida Grande&quot;, Verdana, &quot;Microsoft YaHei&quot;; font-size: 14px;"><span style="font-family:georgia, serif; line-height:23.8px">8000盒batch A0D1226A exp&nbsp;<span style="border-bottom:1px dashed #cccccc; position:relative">2022-11</span>-30</span></div><div style="color: rgb(0, 0, 0); font-family: &quot;lucida Grande&quot;, Verdana, &quot;Microsoft YaHei&quot;; font-size: 14px;"><span style="line-height:23.8px">生产商Baxter</span></div><div style="color: rgb(0, 0, 0); font-family: &quot;lucida Grande&quot;, Verdana, &quot;Microsoft YaHei&quot;; font-size: 14px;"><span style="line-height:23.8px">可提供COA、注册证<img alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=12312453022331647106" style="height:799px; width:600px"></span></div> 参比制剂 http://www.metu.cn/index.php?qa=415&qa_1=%E6%B3%A2%E5%85%B0%E7%9A%84%E8%8D%AF%E5%93%81%E5%BA%93%E5%AD%98%EF%BC%88%E5%9C%A8%E6%B3%A2%E5%85%B0%E8%8D%AF%E5%93%81%E5%90%88%E8%A7%84%E7%9A%84%E5%BA%93%E6%88%BF%EF%BC%89%E7%8E%B0%E8%B4%A7&show=761#a761 Wed, 14 Apr 2021 23:53:18 +0000 http://www.metu.cn/index.php?qa=749&qa_1=%E8%8B%B1%E5%9B%BD%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%8E%B0%E8%B4%A7%E4%B8%8E%E5%BA%93%E5%AD%98%E4%BF%A1%E6%81%AF%EF%BC%8C%E4%B8%8D%E6%96%AD%E6%9B%B4%E6%96%B0 <div>Etab is pleased to be able to off the following EU products</div><div></div><div>&nbsp;<table border="0" cellpadding="0" style="border-collapse:collapse; width:485pt; border-spacing: 0px;"><colgroup><col width="436" style="width: 327pt;"><col width="140" style="width: 105pt;"><col width="71" style="width: 53pt;"></colgroup><tbody><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; width:327pt; height: 21px; width: 436px;" class="xl63">Products</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; width:105pt; width: 140px;" class="xl64">MA Number</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; width:53pt; width: 71px;"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Vyxeos 44mg/100mg powder conc for Infusion 1 vial (50mL)</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/18</span>/1308/001</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Soliris 10mg/ml 30ml Vial</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/07</span>/393/001</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Keytruda 25mg /4ml</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/15</span>/1024/002</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">HULIO 40mg N2 sol for infu</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU /<span style="border-bottom:1px dashed #cccccc">1/18</span>/1319/005</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Imraldi 40 mg sol for inj PEN</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/17</span>/1216/006</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Xtandi 40mg</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/13</span>/846/001</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Perjeta 420mg</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/13</span>/813/001</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Eylea sol.p/inj.40mg</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU/<span style="border-bottom:1px dashed #cccccc">1/12</span>/797/002</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt; height: 21px;" class="xl65">Simponi® 50 mg pre-filled syringe</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt" class="xl66">EU /&nbsp;<span style="border-bottom:1px dashed #cccccc">1/09</span>/546/003</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:16pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; border-top:none; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:15pt; height: 20px;" class="xl68">NOXAFIL 100MG X 24CP GASTROREZ</td><td style="-webkit-font-smoothing:subpixel-antialiased; border-top:none; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:15pt" class="xl69">EU/<span style="border-bottom:1px dashed #cccccc">1/05</span>/320/002</td><td style="-webkit-font-smoothing:subpixel-antialiased; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:15pt"></td></tr><tr><td style="-webkit-font-smoothing:subpixel-antialiased; color:#000000; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:15pt; height: 20px;" class="xl67"></td><td style="-webkit-font-smoothing:subpixel-antialiased; color:#000000; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:12px; height:15pt" class="xl67"></td></tr></tbody></table></div> 参比制剂 http://www.metu.cn/index.php?qa=749&qa_1=%E8%8B%B1%E5%9B%BD%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%8E%B0%E8%B4%A7%E4%B8%8E%E5%BA%93%E5%AD%98%E4%BF%A1%E6%81%AF%EF%BC%8C%E4%B8%8D%E6%96%AD%E6%9B%B4%E6%96%B0 Fri, 12 Mar 2021 01:28:28 +0000 http://www.metu.cn/index.php?qa=745&qa_1=%E6%96%AF%E6%B4%9B%E4%BC%90%E5%85%8B%E5%BA%93%E5%AD%98%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%EF%BC%8C%E5%B8%A6%E6%95%88%E6%9C%9F-%E6%89%B9%E6%AC%A1%E5%8F%B7-%E6%95%B0%E9%87%8F&show=748#c748 SPIRIVA RESPIMAT 2,5 MIKROGRAMU (CZ)&nbsp; &nbsp; INH SOL 1X60DAV+1INHX2,5RG/DAV&nbsp; &nbsp; 2023/3/31&nbsp; &nbsp; 002716E&nbsp; &nbsp; 3<br /> STALEVO 100 MG/25 MG/200 MG (*) &nbsp;FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (100 MG/25 MG/200 MG)&nbsp; &nbsp; 2021/9/30&nbsp; &nbsp; 1893393&nbsp; &nbsp; 2<br /> STALEVO 100 MG/25 MG/200 MG (*) &nbsp;FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (100 MG/25 MG/200 MG)&nbsp; &nbsp; 2023/2/28&nbsp; &nbsp; 2013861&nbsp; &nbsp; 28<br /> STALEVO 100 MG/25 MG/200 MG (*) &nbsp;FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (100 MG/25 MG/200 MG)&nbsp; &nbsp; 2023/5/31&nbsp; &nbsp; 2023835&nbsp; &nbsp; 449<br /> STALEVO 150 MG/37,5 MG/200 (*) MG FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (150 MG/37,5 MG/200 MG)&nbsp; &nbsp; 2022/11/30&nbsp; &nbsp; 2001652&nbsp; &nbsp; 10<br /> STALEVO 150 MG/37,5 MG/200 (*) MG FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (150 MG/37,5 MG/200 MG)&nbsp; &nbsp; 2023/4/30&nbsp; &nbsp; 2019328&nbsp; &nbsp; 135<br /> STALEVO 150 MG/37,5 MG/200 (*) MG FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (150 MG/37,5 MG/200 MG)&nbsp; &nbsp; 2023/8/31&nbsp; &nbsp; 2030747&nbsp; &nbsp; 95<br /> STALEVO 200 MG/50 MG/200 MG (*) FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 100 (200 MG/50 MG/200 MG)&nbsp; &nbsp; 2021/10/31&nbsp; &nbsp; 1905561&nbsp; &nbsp; 1<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 1X120DAV&nbsp; &nbsp; 2022/1/31&nbsp; &nbsp; SLGG&nbsp; &nbsp; 4<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 1X120DAV&nbsp; &nbsp; 2022/2/28&nbsp; &nbsp; SLHX&nbsp; &nbsp; 6<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 1X120DAV&nbsp; &nbsp; 2022/3/31&nbsp; &nbsp; SLLG&nbsp; &nbsp; 9<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 1X120DAV&nbsp; &nbsp; 2022/4/30&nbsp; &nbsp; SLNS&nbsp; &nbsp; 10<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 1X120DAV&nbsp; &nbsp; 2023/7/31&nbsp; &nbsp; KABX&nbsp; &nbsp; 15<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 320MCG/9MCG INH PLV 1X60DAV&nbsp; &nbsp; 2021/8/31&nbsp; &nbsp; PGEW&nbsp; &nbsp; 4<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 320MCG/9MCG INH PLV 1X60DAV&nbsp; &nbsp; 2021/8/31&nbsp; &nbsp; PGFN&nbsp; &nbsp; 5<br /> SYMBICORT TURBUHALER (CZ)&nbsp; &nbsp; 320MCG/9MCG INH PLV 1X60DAV&nbsp; &nbsp; 2022/2/28&nbsp; &nbsp; PGPU&nbsp; &nbsp; 1<br /> SYMBICORT TURBUHALER 100 MIKROGRAMU/6 MIKROGRAMU/INHALACE (CZ)&nbsp; &nbsp; 80MCG/4,5MCG INH PLV 1X120DAV&nbsp; &nbsp; 2021/12/31&nbsp; &nbsp; HAZB&nbsp; &nbsp; 12<br /> SYMBICORT TURBUHALER 160MCG/4,5MCG (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 3X120DAV&nbsp; &nbsp; 2023/5/31&nbsp; &nbsp; KAAK&nbsp; &nbsp; 8<br /> SYMBICORT TURBUHALER 160MCG/4,5MCG (CZ)&nbsp; &nbsp; 160MCG/4,5MCG INH PLV 3X120DAV&nbsp; &nbsp; 2023/5/31&nbsp; &nbsp; KAAM&nbsp; &nbsp; 1<br /> SYMBICORT TURBUHALER 320MCG/9MCG (CZ)&nbsp; &nbsp; 320MCG/9MCG INH PLV 3X60DAV&nbsp; &nbsp; 2023/6/30&nbsp; &nbsp; LABC&nbsp; &nbsp; 11<br /> SYMBICORT TURBUHALER 320MCG/9MCG (CZ)&nbsp; &nbsp; 320MCG/9MCG INH PLV 3X60DAV&nbsp; &nbsp; 2023/10/31&nbsp; &nbsp; LAEB&nbsp; &nbsp; 6<br /> TALTZ 80 MG INJEKCNY ROZTOK NAPLNENY V PERE&nbsp; &nbsp; SOL IRA 2X1 ML/80 MG (STRIEK.INJ.SKL. V PERE)&nbsp; &nbsp; 2022/4/30&nbsp; &nbsp; D254138AK&nbsp; &nbsp; 1<br /> TARKA 180/2 MG TBL. (CZ)&nbsp; &nbsp; 180MG/2MG TBL RET 98&nbsp; &nbsp; 2021/4/30&nbsp; &nbsp; 1123485&nbsp; &nbsp; 3<br /> TOVIAZ 8 MG TABLETY S PREDLZENYM UVOLNOVANIM (*)&nbsp; &nbsp; TBL PLG 28X8 MG (BLISTER AL/AL)&nbsp; &nbsp; 2022/3/31&nbsp; &nbsp; ED1458&nbsp; &nbsp; 3<br /> TOVIAZ 8 MG TABLETY S PREDLZENYM UVOLNOVANIM (*)&nbsp; &nbsp; TBL PLG 28X8 MG (BLISTER AL/AL)&nbsp; &nbsp; 2022/6/30&nbsp; &nbsp; EL2754&nbsp; &nbsp; 10<br /> TWYNSTA 80 MG/10 MG (*) TABLETY&nbsp; &nbsp; TBL 28X80 MG/10 MG (BLIS.PA/AL/PVC/AL)&nbsp; &nbsp; 2022/6/30&nbsp; &nbsp; 20D2041&nbsp; &nbsp; 5<br /> ULTIBRO BREEZHALER 85 MIKROGRAMU/43 MIKROGRAMU CZ&nbsp; &nbsp; 85MCG/43MCG&nbsp; &nbsp; 2021/8/31&nbsp; &nbsp; BNR45&nbsp; &nbsp; 10<br /> UNASYN (CZ)&nbsp; &nbsp; 375MG TBL FLM 12&nbsp; &nbsp; 2022/4/30&nbsp; &nbsp; 3904704&nbsp; &nbsp; 119<br /> UNASYN (CZ)&nbsp; &nbsp; 375MG TBL FLM 12&nbsp; &nbsp; 2022/9/30&nbsp; &nbsp; A3913002&nbsp; &nbsp; 180<br /> URIZIA 6 MG/0,4 MG &nbsp;(CZ) TABLETY S RIZENYM UVOLNOVANIM&nbsp; &nbsp; 6MG/0,4MG TBL RET 100&nbsp; &nbsp; 2022/8/31&nbsp; &nbsp; 19I2237&nbsp; &nbsp; 1<br /> URIZIA 6 MG/0,4 MG &nbsp;(CZ) TABLETY S RIZENYM UVOLNOVANIM&nbsp; &nbsp; 6MG/0,4MG TBL RET 100&nbsp; &nbsp; 2022/9/30&nbsp; &nbsp; 19J2337&nbsp; &nbsp; 3<br /> URIZIA 6 MG/0,4 MG &nbsp;(CZ) TABLETY S RIZENYM UVOLNOVANIM&nbsp; &nbsp; 6MG/0,4MG TBL RET 100&nbsp; &nbsp; 2022/9/30&nbsp; &nbsp; 19J2938&nbsp; &nbsp; 14<br /> URIZIA 6 MG/0,4 MG &nbsp;(CZ) TABLETY S RIZENYM UVOLNOVANIM&nbsp; &nbsp; 6MG/0,4MG TBL RET 100&nbsp; &nbsp; 2023/1/31&nbsp; &nbsp; 20B2336&nbsp; &nbsp; 9<br /> VAGIFEM (CZ)&nbsp; &nbsp; 10MCG VAG TBL NOB 18+18APL&nbsp; &nbsp; 2021/8/31&nbsp; &nbsp; HE71470&nbsp; &nbsp; 2<br /> VENORUTON FORTE (CZ)&nbsp; &nbsp; 500MG TBL NOB 60&nbsp; &nbsp; 2023/6/30&nbsp; &nbsp; VFA18022&nbsp; &nbsp; 399<br /> VERRUMAL (CZ)&nbsp; &nbsp; 5MG/G+100MG/G DRM SOL 13ML&nbsp; &nbsp; 2021/11/30&nbsp; &nbsp; 844272&nbsp; &nbsp; 29<br /> VERRUMAL (CZ)&nbsp; &nbsp; 5MG/G+100MG/G DRM SOL 13ML&nbsp; &nbsp; 2022/3/31&nbsp; &nbsp; 912281&nbsp; &nbsp; 500<br /> VERSATIS 700 MG LIECIVA NAPLAST&nbsp; &nbsp; EMP MED 6X(5X700 MG) (VRE.PAPIER/PE/AL/KOPOL.ETYLENMETAKRYL.KYS.)&nbsp; &nbsp; 2022/7/31&nbsp; &nbsp; 678P04&nbsp; &nbsp; 2<br /> VICTOZA 6 MG/ML (CZ)&nbsp; &nbsp; 6MG/ML INJ SOL 2X3ML&nbsp; &nbsp; 2022/2/28&nbsp; &nbsp; KS6AN43&nbsp; &nbsp; 3<br /> VIMPAT 100 MG (*) FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 56X100 MG (BLIS.PVC/PVDC/AL)&nbsp; &nbsp; 2024/10/31&nbsp; &nbsp; 5926102&nbsp; &nbsp; 3<br /> VIMPAT 200 MG (*) FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 56X200 MG (BLIS.PVC/PVDC/AL)&nbsp; &nbsp; 2024/11/30&nbsp; &nbsp; 7450202&nbsp; &nbsp; 2<br /> VIMPAT 200 MG (CZ)&nbsp; &nbsp; TBL FLM 56X200MG&nbsp; &nbsp; 2025/2/28&nbsp; &nbsp; 7535703&nbsp; &nbsp; 5<br /> VIMPAT 50 MG FILMOM OBALENE TABLETY (*)&nbsp; &nbsp; TBL FLM 14X50 MG (BLIS.PVC/PVDC/AL)&nbsp; &nbsp; 2024/8/31&nbsp; &nbsp; 7390706&nbsp; &nbsp; 4<br /> VIPIDIA 12,5 MG (*)&nbsp; &nbsp; TBL FLM 28X12,5 MG (BLIS.PCTFE/PVC/AL)&nbsp; &nbsp; 2023/6/30&nbsp; &nbsp; 11694412&nbsp; &nbsp; 3<br /> VIPIDIA 12,5 MG (*)&nbsp; &nbsp; TBL FLM 28X12,5 MG (BLIS.PCTFE/PVC/AL)&nbsp; &nbsp; 2024/3/31&nbsp; &nbsp; 11925018&nbsp; &nbsp; 21<br /> VIPIDIA 25 MG (*) FILMOM OBALENE TABLETY&nbsp; &nbsp; TBL FLM 28X25 MG (BLIS.PCTFE/PVC/AL)&nbsp; &nbsp; 2024/4/30&nbsp; &nbsp; 11955606&nbsp; &nbsp; 9<br /> ZOREM (CZ)&nbsp; &nbsp; 5MG TBL NOB 30&nbsp; &nbsp; 2021/2/28&nbsp; &nbsp; 8770&nbsp; &nbsp; 1<br /> ZOREM (CZ)&nbsp; &nbsp; 5MG TBL NOB 30&nbsp; &nbsp; 2021/5/31&nbsp; &nbsp; 10339&nbsp; &nbsp; 1<br /> ZYPREXA VELOTAB (CZ)&nbsp; &nbsp; 15MG POR TBL DIS 28&nbsp; &nbsp; 2021/5/31&nbsp; &nbsp; 1695824A&nbsp; &nbsp; 4<br /> ZYPREXA VELOTAB (CZ)&nbsp; &nbsp; 15MG POR TBL DIS 28&nbsp; &nbsp; 2021/7/31&nbsp; &nbsp; 1704506D&nbsp; &nbsp; 11<br /> (prázdne)&nbsp; &nbsp; (prázdne)&nbsp; &nbsp; (prázdne)&nbsp; &nbsp; (prázdne) 参比制剂 http://www.metu.cn/index.php?qa=745&qa_1=%E6%96%AF%E6%B4%9B%E4%BC%90%E5%85%8B%E5%BA%93%E5%AD%98%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%EF%BC%8C%E5%B8%A6%E6%95%88%E6%9C%9F-%E6%89%B9%E6%AC%A1%E5%8F%B7-%E6%95%B0%E9%87%8F&show=748#c748 Thu, 11 Mar 2021 04:12:17 +0000 http://www.metu.cn/index.php?qa=707&qa_1=%E6%9C%AC%E5%91%A8%E7%BE%8E%E5%9B%BD%E7%83%AD%E9%97%A8%E8%AF%A2%E7%9B%98%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%9B%AE%E5%BD%95%EF%BC%8C%E6%AF%8F%E5%A4%A9%E6%9B%B4%E6%96%B0&show=741#c741 美国 腹膜透析液 现货Dianeal low calcium with 1.5% Dextrose<br /> Baxter 6*2000ml<br /> NDC:0941-0424-52<br /> <br /> 批次 Y344760，效期 12/2021，2箱<br /> 批次 Y341813，效期 11/2021，2箱<br /> 批次 Y341790，效期 11/2021，1箱<br /> 现货便宜处理 参比制剂 http://www.metu.cn/index.php?qa=707&qa_1=%E6%9C%AC%E5%91%A8%E7%BE%8E%E5%9B%BD%E7%83%AD%E9%97%A8%E8%AF%A2%E7%9B%98%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%9B%AE%E5%BD%95%EF%BC%8C%E6%AF%8F%E5%A4%A9%E6%9B%B4%E6%96%B0&show=741#c741 Wed, 03 Feb 2021 00:07:58 +0000 http://www.metu.cn/index.php?qa=732&qa_1=%E4%BF%9D%E5%8A%A0%E5%88%A9%E4%BA%9A%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%9B%AE%E5%BD%95-%E9%9A%8F%E6%97%B6%E7%90%86%E6%96%B0&show=740#c740 TOSTRAN GEL 2% 60GR<br /> <br /> 30.44<br /> <br /> TOUJEO PF.PEN 3x1,5MLx300U/ML (SOLOSTAR)<br /> <br /> 40.12<br /> <br /> TOUJEO SOLOST.INJ.SOL. 3x1.5ml/450iu/ml<br /> <br /> 40.71<br /> <br /> TOVANOR BREEZHALER CAPS 30x44mcg<br /> <br /> 35.70<br /> <br /> TOVIAZ PR TABL. 30x4MG<br /> <br /> 26.08<br /> <br /> TOVIAZ PR TABL. 30x8MG<br /> <br /> 27.14<br /> <br /> TRESIBA PF.PEN 5x3MLx100U/ML<br /> <br /> 64.31<br /> <br /> TRILEPTAL ORAL SUSP.250mlx60mg/ml<br /> <br /> 28.14<br /> <br /> TRILEPTAL TABL 50 Χ 600MG<br /> <br /> 22.54<br /> <br /> TRIMBOW INH.SOL.P (87+5+9)MCG/DOSE 1<br /> <br /> 66.20<br /> <br /> TRIPLIXAM F.C.TABL. 30x(10+2,5+10)MG<br /> <br /> 11.45<br /> <br /> ULTIBRO BREEZHALER INHPD.CAP (85+43)MCG/DOSE BTx30<br /> <br /> 56.64<br /> <br /> UROREC CAPS 30x4MG<br /> <br /> 5.55<br /> <br /> VAGIFEM &nbsp;VAG 10 MICROGRAMS 18 TABS<br /> <br /> 18.88<br /> <br /> VALDOXAN F.C.TABL. 28x25MG<br /> <br /> 30.68<br /> <br /> VALTREX F.C.TABL. 42x500MG<br /> <br /> 35.87<br /> <br /> VASTAREL F.C.TABL. 60x20MG<br /> <br /> 3.78<br /> <br /> VERMOX TABS 6 Χ 100MG<br /> <br /> 1.42<br /> <br /> VERRUCA HERMAL CUT.SOL SOL.EXT.US FLx13ML<br /> <br /> 4.72<br /> <br /> VESICARE TABL.30x10mg<br /> <br /> 21.83<br /> <br /> VIAGRA F.C.TABL. 4x50MG<br /> <br /> 19.47<br /> <br /> VIBRAMYCIN TABL.DISP.8x100mg<br /> <br /> 1.71<br /> <br /> VIMPAT F.C.TAB 56x100MG (BLIST)<br /> <br /> 115.64<br /> <br /> VIMPAT F.C.TAB 56x200MG (BLIST)<br /> <br /> 191.16<br /> <br /> VIMPAT F.C.TABL. 14x150MG<br /> <br /> 31.86<br /> <br /> VOLTARENE TABL.DISP.20x50mg<br /> <br /> 1.83<br /> <br /> VOLTAROL FORTE 2,32% 100G<br /> <br /> 8.32<br /> <br /> WELLBRUTIN XR TABS 30 X 150MG<br /> <br /> 13.16<br /> <br /> XAMIOL GEL 60GR X (0.5MG+50MCG)<br /> <br /> 42.19<br /> <br /> XARELTO TABS F/C 10 X 10MG<br /> <br /> 23.42<br /> <br /> XARELTO TABS F/C 28 X 15MG<br /> <br /> 68.79<br /> <br /> XARELTO TABS F/C 28 X 20MG<br /> <br /> 67.85<br /> <br /> XENICAL CAPS 84x120mg<br /> <br /> 34.81<br /> <br /> XEPLION 100MG BTx1PF.SYR.x100MG+2 ΒΕΛΟΝΕΣ<br /> <br /> 482.62<br /> <br /> XEPLION 150MG PF.SYR INJ.SU.PRO BTx1PF.SYRx150MG +2 βελόνες<br /> <br /> 713.90<br /> <br /> XEPLION 75MG BTx1PF.SYR.x75MG+2 ΒΕΛΟΝΕΣ<br /> <br /> 362.26<br /> <br /> XOTERNA-BREEZHALER INH 30x(85+43)MCG/DOSE<br /> <br /> 55.46<br /> <br /> X-PREP SIROP 75mlx10mg/5ml<br /> <br /> 2.54<br /> <br /> ZEMPLAR CAPS 28x1MCG<br /> <br /> 51.21<br /> <br /> ZOFEPRIL F.C.TABL. 28x30MG<br /> <br /> 7.38<br /> <br /> ZOLADEX 1 INJ. Χ &nbsp;3,6MG<br /> <br /> 330.40<br /> <br /> ZOLADEX 1 INJ. Χ 10,8MG<br /> <br /> 95.11<br /> <br /> ZONEGRAN CAPS HARD 56 X 100MG<br /> <br /> 43.66<br /> <br /> ZONEGRAN HARD CAPS 28x50MG<br /> <br /> 9.68<br /> <br /> ZOVIRAX CREAM 2GR<br /> <br /> 3.54<br /> <br /> ZYPREXA PD INJ.SOL.1VIAL 10MG<br /> <br /> 4.01 参比制剂 http://www.metu.cn/index.php?qa=732&qa_1=%E4%BF%9D%E5%8A%A0%E5%88%A9%E4%BA%9A%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%9B%AE%E5%BD%95-%E9%9A%8F%E6%97%B6%E7%90%86%E6%96%B0&show=740#c740 Wed, 03 Feb 2021 00:03:42 +0000 http://www.metu.cn/index.php?qa=190&qa_1=%E5%9C%9F%E8%80%B3%E5%85%B6%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E8%8D%AF%E5%93%81%E5%BA%93%E5%AD%98%EF%BC%8C%E5%9C%9F%E8%80%B3%E5%85%B6%E8%8D%AF%E5%93%81&show=731#c731 NO&nbsp; &nbsp; COMMERCIAL NAME&nbsp; &nbsp; ACTIVE INGREDIENT&nbsp; &nbsp; MANUFACTURER&nbsp; &nbsp; COO<br /> 1&nbsp; &nbsp; ADACEL&nbsp; &nbsp; Diphtheria, Tetanus Toxoids and Acellular Pertussis Vaccine&nbsp; &nbsp; SANOFİ PASTEUR&nbsp; &nbsp; CANADA<br /> 2&nbsp; &nbsp; BEXSERO&nbsp; &nbsp; Meningococcal Group B Vaccine&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; ITALY<br /> 3&nbsp; &nbsp; BOOSTİRIX&nbsp; &nbsp; Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; FRANCE<br /> 4&nbsp; &nbsp; BOOSTİRIX POLIO&nbsp; &nbsp; Combined DTPa and İnactivated Poliomyelitis Vaccine&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; FRANCE<br /> 5&nbsp; &nbsp; ENGERİX PEDIATRIC&nbsp; &nbsp; Hepatitis B vaccine (rDNA), adjuvanted, monovalent&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 6&nbsp; &nbsp; ENGERİX ADULT&nbsp; &nbsp; Hepatitis B vaccine (rDNA), adjuvanted, monovalent&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 7&nbsp; &nbsp; GARDASİL&nbsp; &nbsp; Human papillomavirus vaccinia, recombinant, tetravalent&nbsp; &nbsp; MERCK SHARP &amp; DOHME&nbsp; &nbsp; USA<br /> 8&nbsp; &nbsp; HAVRİX 1440ADULT&nbsp; &nbsp; Hepatitis A Vaccine, Inactivated&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 9&nbsp; &nbsp; HAVRİX PEDIATRIC&nbsp; &nbsp; Hepatitis A Vaccine, Inactivated&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 10&nbsp; &nbsp; H VAC&nbsp; &nbsp; Hepatitis B vaccine (rDNA), adjuvanted, monovalent&nbsp; &nbsp; KEYMEN&nbsp; &nbsp; INDIA<br /> 11&nbsp; &nbsp; HEXAXIM&nbsp; &nbsp; DTaP, inactivated poliovirus, Hib, hepatitis B conjugate vaccine&nbsp; &nbsp; SANOFİ PASTEUR&nbsp; &nbsp; FRANCE<br /> 12&nbsp; &nbsp; HIBERİX&nbsp; &nbsp; Haemophilus influenzae type B (Hib) vaccine&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 13&nbsp; &nbsp; MENACTRA&nbsp; &nbsp; Meningococcal (Groups A,C,Y,W-135)Diphtheria Conjugate Vacc&nbsp; &nbsp; SANOFİ PASTEUR&nbsp; &nbsp; USA<br /> 14&nbsp; &nbsp; MENVEO&nbsp; &nbsp; Meningococcal oligosaccharide-CRM vaccine,(A, C, W135, Y)&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; ITALY<br /> 15&nbsp; &nbsp; NİMENRİX&nbsp; &nbsp; Meningococcal group A, C, W 135 and Y conjugate vaccine&nbsp; &nbsp; PFİZER PFE&nbsp; &nbsp; BELGIUM<br /> 16&nbsp; &nbsp; PREVENAR&nbsp; &nbsp; Pneumococcal Conjugate Vaccine (13-Valent)&nbsp; &nbsp; PFİZER PFE&nbsp; &nbsp; TURKEY<br /> 17&nbsp; &nbsp; PRİORİX&nbsp; &nbsp; Measles, Mumps, and Rubella Virus Vaccine&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 18&nbsp; &nbsp; ROTARIX APLC&nbsp; &nbsp; Human rotavirus, live attenuated&nbsp; &nbsp; GLAXOSMITHKLINE&nbsp; &nbsp; BELGIUM<br /> 19&nbsp; &nbsp; ROTATEQ&nbsp; &nbsp; Rotavirus vaccine, live, oral, pentavalent1&nbsp; &nbsp; MERCK SHARP &amp; DOHME&nbsp; &nbsp; USA<br /> 20&nbsp; &nbsp; TD-VAC&nbsp; &nbsp; Adsorbed diphtheria and tetanus vaccine&nbsp; &nbsp; KEYMEN&nbsp; &nbsp; INDIA<br /> 21&nbsp; &nbsp; TETAVAX&nbsp; &nbsp; Adsorbed tetanus vaccine&nbsp; &nbsp; SANOFİ PASTEUR&nbsp; &nbsp; FRANCE 参比制剂 http://www.metu.cn/index.php?qa=190&qa_1=%E5%9C%9F%E8%80%B3%E5%85%B6%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E8%8D%AF%E5%93%81%E5%BA%93%E5%AD%98%EF%BC%8C%E5%9C%9F%E8%80%B3%E5%85%B6%E8%8D%AF%E5%93%81&show=731#c731 Tue, 19 Jan 2021 04:02:56 +0000 http://www.metu.cn/index.php?qa=726&qa_1=%E7%96%AB%E8%8B%97%E5%8F%AF%E4%BE%9B%E7%9A%84%E4%BA%A7%E5%93%81%EF%BC%88%E6%8A%A5%E4%BB%B7%E9%9A%8F%E6%97%B6%E6%9B%B4%E6%96%B0%EF%BC%89&show=727#c727 HEPATITISAB TWINRIX AHABB416AX 30/05/2022 140 € 44,36<br /> <br /> HEPATITISAB10 Engerix pack 10 AHABB421AH 31/08/2022 105 € 443,63<br /> <br /> HEPATITISB Engerix Single NL AHBVC868AB 31/03/2022 1835 € 26,85<br /> <br /> MALARIAPROVE Malarone NL ME5E 30/10/2024 979 € 15,34<br /> <br /> 16117190 NEISVAC-C 20 MCG/ML WWSP 0,5ML AR0643 31/12/2021 3 € 78,84<br /> <br /> 16201922 NIMENRIX INJPDR FLACON + SOLVENS IN WWSP CJ3907 31/12/2022 113 € 51,90<br /> <br /> 16272366 PNEUMOVAX 23 VOORGEVULDE SPUIT / 1031476 NL 1036859 31/07/2022 20 € 28,27<br /> <br /> 15570525 POLIOVACCIN NVI FLACON0,5ML 1ST/18859 1949004A 04/11/2022 3 € 9,38<br /> <br /> 15537439 PREVENAR 13 INJSUSP WWSP 0,5ML DD0481 31/10/2022 36 € 81,41<br /> <br /> 15229378 PROVARIVAX INJPDR + SOLV / 1003764 T000615 31/12/2021 23 € 52,78<br /> <br /> 273-7849 RABIPUR (UK) UK ARBA101A 28/02/2022 5 € 57,50<br /> <br /> 705430 RABIPUR WWSP + FLACON INCL. NAALDEN ARBA581B 31/05/2023 119 € 66,45<br /> <br /> 16324684 RABIPUR WWSP + FLACON INCL. NAALDEN (GSK ARBA581B 31/05/2023 323 € 68,50<br /> <br /> 14818434 REVAXIS INJSUSP WWSP 0,5ML R3N416V 31/08/2021 294 € 15,05<br /> <br /> 15922766 REVAXIS INJSUSP WWSP 0,5ML 10 x 1 VERP R3N241V 31/10/2021 31 € 153,78<br /> <br /> 16902327 SHINGRIX 93DL9 31/08/2022 72 € 200,75<br /> <br /> 16408683 STAMARIL INJPDR FL+SOLV 0,5ML OMPAK (IT) NL 20B426 31/08/2021 100 € 31,25<br /> <br /> 16408683 STAMARIL INJPDR FL+SOLV 0,5ML OMPAK (IT) NL 20C507 31/08/2021 1000 € 31,25<br /> <br /> 16408683 STAMARIL INJPDR FL+SOLV 0,5ML OMPAK (IT) NL 20D80 31/08/2021 60 € 31,25<br /> <br /> 16408683 STAMARIL INJPDR FL+SOLV 0,5ML OMPAK (IT) NL 20D81 31/08/2021 389 € 31,25<br /> <br /> 14733250 STAMARIL INJPDR FLACON + SOLV 0,5ML R3N065V 31/08/2021 1198 € 46,13<br /> <br /> 16845455 SYNFLORIX INJSUSP WWSP 0.5ML + TOEBEH ASPNB280CF 30/08/2023 2 € 71,41<br /> <br /> 12147974 TETANUS MONODOSIS / 10087 2020001B 30/01/2025 236 € 9,38<br /> <br /> 14184222 TUBERCULINE PPDRT23 SSI 20TE/ML FL 1,5ML TB0031B 30/06/2022 50 € 38,36<br /> <br /> 15544877 TWINRIX ADULT INJSUSP 1ML OMPAK (BG) BG 20H505.025 30/06/2022 549 € 33,47<br /> <br /> 14229013 TWINRIX ADULT INJSUSP WWSP 1ML NL AHABB416AX 31/05/2022 1173 € 49,30<br /> <br /> 14229005 TWINRIX ADULT INJSUSP WWSP 1ML/10 NL AHABB421AH 31/08/2022 106 € 493,00<br /> <br /> 13915134 TYPHIM VI WWSP 0,5ML R2A764M 30/09/2021 243 € 31,48<br /> <br /> 14581108 VAQTA JUNIOR INJSUSP 50E/ML &nbsp;/ 1998290 S022469 31/08/2021 2 € 17,50<br /> <br /> 14581108 VAQTA JUNIOR INJSUSP 50E/ML &nbsp;/ 1998290 T011572 31/10/2021 20 € 17,50<br /> <br /> 15368696 ZOSTAVAX INJPDR FLAC+SOLV 0,65ML/1003926 T009484 31/07/2021 1 € 165,34 参比制剂 http://www.metu.cn/index.php?qa=726&qa_1=%E7%96%AB%E8%8B%97%E5%8F%AF%E4%BE%9B%E7%9A%84%E4%BA%A7%E5%93%81%EF%BC%88%E6%8A%A5%E4%BB%B7%E9%9A%8F%E6%97%B6%E6%9B%B4%E6%96%B0%EF%BC%89&show=727#c727 Mon, 11 Jan 2021 12:23:34 +0000 http://www.metu.cn/index.php?qa=148&qa_1=%E5%BE%B7%E5%9B%BD%E7%8E%B0%E8%B4%A7%E5%BA%93%E5%AD%98200%E5%A4%9A%E7%A7%8D%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E8%8D%AF%E5%93%81%E7%8E%B0%E8%B4%A7%EF%BC%8C%E6%9C%89%E8%BF%91%E6%95%88%E6%9C%9F%E4%B8%8E%E4%B8%8E%E8%BF%9C%E6%95%88%E6%9C%9F%E7%9A%84%EF%BC%8C%E6%AC%A2%E8%BF%8E%E9%80%89%E8%B4%AD&show=717#a717 <p><img style="height:316px; width:600px" alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=13803996607786966341"><img style="height:310px; width:600px" alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=5056820551550944378"><img style="height:358px; width:600px" alt="" src="http://www.metu.cn/?qa=blob&amp;qa_blobid=16928240184991036466"><strong><span style="font-family:Georgia"><span style="color:#000000">&nbsp;Influsplit (</span><span style="color:#000000">GSK</span><span style="color:#000000">&nbsp;Flu Vaccination)</span></span></strong></p> 参比制剂 http://www.metu.cn/index.php?qa=148&qa_1=%E5%BE%B7%E5%9B%BD%E7%8E%B0%E8%B4%A7%E5%BA%93%E5%AD%98200%E5%A4%9A%E7%A7%8D%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E8%8D%AF%E5%93%81%E7%8E%B0%E8%B4%A7%EF%BC%8C%E6%9C%89%E8%BF%91%E6%95%88%E6%9C%9F%E4%B8%8E%E4%B8%8E%E8%BF%9C%E6%95%88%E6%9C%9F%E7%9A%84%EF%BC%8C%E6%AC%A2%E8%BF%8E%E9%80%89%E8%B4%AD&show=717#a717 Wed, 25 Nov 2020 02:12:25 +0000 http://www.metu.cn/index.php?qa=574&qa_1=%E6%B3%95%E5%9B%BD%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%8E%B0%E8%B4%A7%E5%BA%93%E5%AD%98%EF%BC%8C%E5%B8%A6%E5%A4%9A%E6%89%B9%E6%AC%A1%E5%8F%B7&show=715#a715 注射用培美曲塞二钠 Alimta 500mg 1 vial<br /> Expiry 04-2022, single batch<br /> Quantity: 1000 packs ready<br /> (additional 500 packs per month available)<br /> Documents: COC, COA, Declaration of Drug Product<br /> Manufactured: Eli Lilly, Indiana, USA（CPP,产品质量证书）<br /> Released site: Lilly France, Fegersheim, France. 参比制剂 http://www.metu.cn/index.php?qa=574&qa_1=%E6%B3%95%E5%9B%BD%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%8E%B0%E8%B4%A7%E5%BA%93%E5%AD%98%EF%BC%8C%E5%B8%A6%E5%A4%9A%E6%89%B9%E6%AC%A1%E5%8F%B7&show=715#a715 Tue, 24 Nov 2020 06:19:44 +0000 http://www.metu.cn/index.php?qa=713&qa_1=%E3%80%8A%E5%8C%96%E5%AD%A6%E4%BB%BF%E5%88%B6%E8%8D%AF%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%9B%AE%E5%BD%95%EF%BC%88%E7%AC%AC%E4%B8%89%E5%8D%81%E4%BA%94%E6%89%B9%EF%BC%89%E3%80%8B%E7%9A%84%E5%85%AC%E7%A4%BA%EF%BC%8C27%E4%B8%AA%E6%96%B0%E5%A2%9E%EF%BC%8C15%E5%A2%9E%E8%A1%A5&show=714#c714 化学仿制药参比制剂目录（第三十五批）（征求意见稿）<br /> 序号&nbsp; &nbsp; 药品通用名称&nbsp; &nbsp; 英文名称/商品名&nbsp; &nbsp; 规格&nbsp; &nbsp; 持证商&nbsp; &nbsp; 备注1&nbsp; &nbsp; 备注2 <br /> 35-1&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 六氟化硫微泡&nbsp; &nbsp; Sulfur Hexafluoride Microbubbles for Injection/ SonoVue（声诺维）&nbsp; &nbsp; 59 mg&nbsp; &nbsp; Bracco International B.V.&nbsp; &nbsp; 国内上市的原研药品&nbsp; &nbsp; 原研进口<br /> 35-2&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone for Depot Suspension/Risperdal Consta（恒德）&nbsp; &nbsp; 25 mg&nbsp; &nbsp; Janssen-Cilag AG/Janssen Pharmaceutica N.V.&nbsp; &nbsp; 国内上市的原研药品&nbsp; &nbsp; 原研进口<br /> 35-3&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone for Depot Suspension/Risperdal Consta（恒德）&nbsp; &nbsp; 37.5 mg&nbsp; &nbsp; Janssen-Cilag AG/Janssen Pharmaceutica N.V.&nbsp; &nbsp; 国内上市的原研药品&nbsp; &nbsp; 原研进口<br /> 35-4&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone for Depot Suspension/Risperdal Consta（恒德）&nbsp; &nbsp; 50 mg&nbsp; &nbsp; Janssen-Cilag AG/Janssen Pharmaceutica N.V.&nbsp; &nbsp; 国内上市的原研药品&nbsp; &nbsp; 原研进口<br /> 35-5&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone Long-acting Injection/Risperdal Consta&nbsp; &nbsp; 12.5mg&nbsp; &nbsp; Janssen Pharmaceuticals, Inc.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-6&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone Long-acting <br /> Injection/Risperdal Consta&nbsp; &nbsp; 25 mg&nbsp; &nbsp; Janssen Pharmaceuticals, Inc.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-7&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone Long-acting Injection/Risperdal Consta&nbsp; &nbsp; 37.5 mg&nbsp; &nbsp; Janssen Pharmaceuticals, Inc.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-8&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone Long-acting Injection/Risperdal Consta&nbsp; &nbsp; 50 mg&nbsp; &nbsp; Janssen Pharmaceuticals, Inc.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-9&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone powder and solvent for depot suspension for Injection/Risperdal Consta&nbsp; &nbsp; 25 mg&nbsp; &nbsp; Janssen-Cilag GmbH&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-10&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone powder and solvent for depot suspension for Injection/Risperdal Consta&nbsp; &nbsp; 37.5 mg&nbsp; &nbsp; Janssen-Cilag GmbH&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-11&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 利培酮微球&nbsp; &nbsp; Risperidone powder and solvent for depot suspension for Injection/Risperdal Consta&nbsp; &nbsp; 50 mg&nbsp; &nbsp; Janssen-Cilag GmbH&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-12&nbsp; &nbsp; &nbsp; &nbsp; 普拉曲沙注射液&nbsp; &nbsp; Pralatrexate Injection/Folotyn&nbsp; &nbsp; 20mg/ml&nbsp; &nbsp; Acrotech <br /> Biopharma LLC&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-13&nbsp; &nbsp; &nbsp; &nbsp; 酒石酸<br /> 匹莫范色林片&nbsp; &nbsp; Pimavanserin Tartrate Capsules/Nuplazid&nbsp; &nbsp; 10mg（以匹莫范色林计）&nbsp; &nbsp; Acadia <br /> Pharmaceuticals Inc&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-14&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 苯唑西林钠&nbsp; &nbsp; Oxacillin Sodium for Injection&nbsp; &nbsp; 以C19H19N3O5S计1.0g&nbsp; &nbsp; Sagent <br /> Pharmaceuticals Inc&nbsp; &nbsp; 国际公认的同种药品&nbsp; &nbsp; 美国橙皮书<br /> 35-15&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 苯唑西林钠&nbsp; &nbsp; Oxacillin Sodium for Injection&nbsp; &nbsp; 以C19H19N3O5S计2.0g&nbsp; &nbsp; Sagent <br /> Pharmaceuticals Inc&nbsp; &nbsp; 国际公认的同种药品&nbsp; &nbsp; 美国橙皮书<br /> 35-16&nbsp; &nbsp; &nbsp; &nbsp; 盐酸去氧<br /> 肾上腺素注射液&nbsp; &nbsp; Phenylephrine Hydrochloride Injection/Vazculep&nbsp; &nbsp; 10mg/ml&nbsp; &nbsp; Avaedl Legacy&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-17&nbsp; &nbsp; &nbsp; &nbsp; 小儿复方氨基酸注射液（20AA）&nbsp; &nbsp; Amino Acid Solution for Infusion/Primene&nbsp; &nbsp; 10%<br /> （100ml/250ml）&nbsp; &nbsp; Baxter&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-18&nbsp; &nbsp; &nbsp; &nbsp; 小儿复方氨基酸注射液（20AA）&nbsp; &nbsp; Amino Acid Intravenous Infusion/Primene&nbsp; &nbsp; 10%（100ml/250ml）&nbsp; &nbsp; Baxter Healthcare <br /> Pty Ltd&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 澳大利亚上市<br /> 35-19&nbsp; &nbsp; &nbsp; &nbsp; 琥珀酸<br /> 呋罗曲坦片&nbsp; &nbsp; Frovatriptan Tablet/Isimig&nbsp; &nbsp; 2.5mg&nbsp; &nbsp; Menarini International Operations Luxembourg SA&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-20&nbsp; &nbsp; &nbsp; &nbsp; 间苯三酚<br /> 口服冻干片&nbsp; &nbsp; Phloroglucinol Oral Lyophilisates/ Spasfon Lyoc&nbsp; &nbsp; 160mg&nbsp; &nbsp; Teva Sante&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-21&nbsp; &nbsp; &nbsp; &nbsp; 复方磺胺甲噁唑注射液&nbsp; &nbsp; Sulfamethoxazole and Trimethoprim Injection/Bactrim&nbsp; &nbsp; 5ml，<br /> 磺胺甲噁唑80mg/ml，<br /> 甲氧苄啶16mg/ml&nbsp; &nbsp; Roche S.p.A&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-22&nbsp; &nbsp; &nbsp; &nbsp; 依托芬那酯凝胶&nbsp; &nbsp; Etofenamate Gel/Traumon&nbsp; &nbsp; 5%（50g，100g）&nbsp; &nbsp; MEDA Manufacturing GmbH&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-23&nbsp; &nbsp; &nbsp; &nbsp; 依托芬那酯凝胶&nbsp; &nbsp; Etofenamate Gel/Traumon&nbsp; &nbsp; 10%（50g，100g）&nbsp; &nbsp; MEDA Manufacturing GmbH&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-24&nbsp; &nbsp; &nbsp; &nbsp; 盐酸非索非那定干糖浆&nbsp; &nbsp; Fexofenadine Hydrochloride Dry Syrup/Allegra&nbsp; &nbsp; 1g中含盐酸非索非那定50mg&nbsp; &nbsp; サノフィ株式会社（赛诺菲株式会社）&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 日本上市<br /> 35-25&nbsp; &nbsp; &nbsp; &nbsp; 甲基多巴片&nbsp; &nbsp; Methyldopa Tablets/Aldomet&nbsp; &nbsp; 250mg&nbsp; &nbsp; 株式会社ミノファーゲン製薬&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 日本上市<br /> 35-26&nbsp; &nbsp; &nbsp; &nbsp; 注射用盐酸<br /> 罗沙替丁醋酸酯&nbsp; &nbsp; Roxatidine Acetate Hydrochloride For Injection/Altat&nbsp; &nbsp; 75mg&nbsp; &nbsp; あすか製薬株式会社&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 日本上市<br /> 35-27&nbsp; &nbsp; &nbsp; &nbsp; 瑞卢戈利片&nbsp; &nbsp; Relugolix Tablets/Relumina&nbsp; &nbsp; 40mg&nbsp; &nbsp; 武田药品工业株式会社/あすか制药株式会社&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 日本上市<br /> 备注&nbsp; &nbsp; 1.未在国内上市品种，需参照原总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。<br /> 2.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。<br /> 3.欧盟上市的参比制剂包括其在英国上市的同一药品。<br /> 4.选择未进口参比制剂开展仿制药研究除满足其质量要求外，还需满足现行版《中国药典》和相关指导原则要求。<br />  <br /> 附件2<br /> 已发布化学仿制药参比制剂目录（增补）（征求意见稿）<br /> 序号&nbsp; &nbsp; 药品通用名称&nbsp; &nbsp; 英文名称/商品名&nbsp; &nbsp; 规格&nbsp; &nbsp; 持证商&nbsp; &nbsp; 备注1&nbsp; &nbsp; 备注2 <br /> 35-28&nbsp; &nbsp; &nbsp; &nbsp; 拉考沙胺注射液&nbsp; &nbsp; Lacosamide Injection/Vimpat&nbsp; &nbsp; 10mg/ml&nbsp; &nbsp; UCB Pharma S.A.&nbsp; &nbsp; 国内上市的原研药品&nbsp; &nbsp; 原研进口<br /> 35-29&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 醋酸卡泊芬净&nbsp; &nbsp; Caspofungin Acetate for Injection/Cancidas&nbsp; &nbsp; 50mg&nbsp; &nbsp; Merck and Co INC&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-30&nbsp; &nbsp; &nbsp; &nbsp; 注射用<br /> 醋酸卡泊芬净&nbsp; &nbsp; Caspofungin Acetate for Injection/Cancidas&nbsp; &nbsp; 70mg&nbsp; &nbsp; Merck and Co INC&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-31&nbsp; &nbsp; &nbsp; &nbsp; 注射用右雷佐生&nbsp; &nbsp; Dexrazoxane for Injection/Zinecard&nbsp; &nbsp; 500mg&nbsp; &nbsp; Pharmacia and Upjohn Co&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-32&nbsp; &nbsp; &nbsp; &nbsp; 注射用唑来膦酸浓溶液&nbsp; &nbsp; Zoledronic Acid Concentrated Solution for Injection/Zometa&nbsp; &nbsp; 5ml:4mg&nbsp; &nbsp; Novartis Pharmaceuticals Corp&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-33&nbsp; &nbsp; &nbsp; &nbsp; 盐酸多塞平片&nbsp; &nbsp; Doxepin Hydrochloride Tablets /Silenor&nbsp; &nbsp; 6mg&nbsp; &nbsp; Currax Pharmaceuticals LLC&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-34&nbsp; &nbsp; &nbsp; &nbsp; 氯氮平片&nbsp; &nbsp; Clozapine Tablets/Clozaril&nbsp; &nbsp; 0.1g&nbsp; &nbsp; Heritage Life Sciences Barbados INC&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-35&nbsp; &nbsp; &nbsp; &nbsp; 麦考酚钠肠溶片&nbsp; &nbsp; Mycophenolate Sodium Enteric-coated tablets/Myfortic&nbsp; &nbsp; 180mg&nbsp; &nbsp; Novartis Pharmaceuticals Corporation&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-36&nbsp; &nbsp; &nbsp; &nbsp; 盐酸二甲双胍缓释片&nbsp; &nbsp; Metformin Hydrochloride Extended-release Tablets/Fortamet&nbsp; &nbsp; 1g&nbsp; &nbsp; Andrx Labs LLC&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书<br /> 35-37&nbsp; &nbsp; &nbsp; &nbsp; 司来帕格片&nbsp; &nbsp; Selexipag Tablets/ Uptravi&nbsp; &nbsp; 0.4mg&nbsp; &nbsp; Janssen-Cilag International NV&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市<br /> 35-38&nbsp; &nbsp; &nbsp; &nbsp; 左氧氟沙星<br /> 氯化钠注射液&nbsp; &nbsp; Levofloxacin and Sodium Chloride Injection /Tavanic&nbsp; &nbsp; 50ml:250mg&nbsp; &nbsp; Sanofi-Aventis Deutschland GmbH&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 德国上市<br /> 35-39&nbsp; &nbsp; &nbsp; &nbsp; 托拉塞米片&nbsp; &nbsp; Torasemide Tablets /Unat&nbsp; &nbsp; 5mg&nbsp; &nbsp; MEDA Pharma GmbH &amp; Co. KG&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 德国上市<br /> 35-40&nbsp; &nbsp; &nbsp; &nbsp; 紫杉醇注射液&nbsp; &nbsp; Paclitaxel Injection/Taxol&nbsp; &nbsp; 16.7ml:100mg&nbsp; &nbsp; Bristol-Myers Squibb S.R.L.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 瑞士上市<br /> 8-88&nbsp; &nbsp; 利巴韦林片&nbsp; &nbsp; Ribavirin Tablets/Copegus&nbsp; &nbsp; 0.2g&nbsp; &nbsp; Roche Products Limited/<br /> Roche S.p.A/<br /> Roche Pharma AG&nbsp; &nbsp; 欧盟上市&nbsp; &nbsp; 增加持证商<br /> Roche S.p.A/<br /> Roche Pharma AG；不限定产地<br /> 8-179&nbsp; &nbsp; 盐酸替扎尼定片&nbsp; &nbsp; Tizanidine Hydrochloride Tablets /Sirdalud&nbsp; &nbsp; 2mg&nbsp; &nbsp; Novartis Pharma GmbH&nbsp; &nbsp; 欧盟上市&nbsp; &nbsp; 修订，不限定产地<br /> 备注&nbsp; &nbsp; 1.未在国内上市品种，需参照原总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。<br /> 2.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。<br /> 3.欧盟上市的参比制剂包括其在英国上市的同一药品。<br /> 4.选择未进口参比制剂开展仿制药研究除满足其质量要求外，还需满足现行版《中国药典》和相关指导原则要求。<br /> 附件3<br /> 未通过审议品种目录<br /> 序号&nbsp; &nbsp; 药品通用名称&nbsp; &nbsp; 英文名称/商品名&nbsp; &nbsp; 规格&nbsp; &nbsp; 持证商&nbsp; &nbsp; 备注1&nbsp; &nbsp; 备注2 &nbsp; &nbsp; 遴选情况说明<br /> 35-41&nbsp; &nbsp; &nbsp; &nbsp; 氟轻松油剂&nbsp; &nbsp; Fluocinolone Acetonide Oil/ Derma-Smoothe/FS&nbsp; &nbsp; 0.01%&nbsp; &nbsp; Hill Dermaceuticals Inc&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 美国橙皮书&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请参比制剂在美国上市较早（1988年），且未在欧盟和日本上市。此外，国内氟轻松制剂规格多为0.025%，与本品不同。综上，审议未通过。<br /> 35-42&nbsp; &nbsp; &nbsp; &nbsp; 地氯雷他定口崩片&nbsp; &nbsp; Ddesloratadine Orodispersible Tablets/Aerius&nbsp; &nbsp; 2.5mg&nbsp; &nbsp; Merck Sharp &amp; Dohme B.V.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请剂型为口崩片，仅为临床提供一种剂型选择，与已上市其他口服制剂比较无临床应用优势。综上，审议未通过。<br /> 35-43&nbsp; &nbsp; &nbsp; &nbsp; 地氯雷他定口崩片&nbsp; &nbsp; Ddesloratadine Orodispersible Tablets/Aerius&nbsp; &nbsp; 5mg&nbsp; &nbsp; Merck Sharp &amp; Dohme B.V.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市&nbsp; &nbsp; 同上。<br /> 35-44&nbsp; &nbsp; &nbsp; &nbsp; 盐酸乙酰左卡尼汀肠溶片&nbsp; &nbsp; Acetyllevocarnitine Hydrochloride Enteric-Coated Tablets/ Nicetile&nbsp; &nbsp; 0.5g&nbsp; &nbsp; Alfasigma S.p.A.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 欧盟上市&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请参比制剂适应症的安全有效性数据不确切。此外，原研曾申报进口，其申报资料尚不足以支持本品对于所申请适应症的有效性，结论为不批准。综上，审议未通过。<br /> 35-45&nbsp; &nbsp; &nbsp; &nbsp; 复方氨基酸注射液（18AA-Ⅲ）&nbsp; &nbsp; Compound Amino Acid Injection（18AA-Ⅲ）/Moripron&nbsp; &nbsp; 200ml：20.720g&nbsp; &nbsp; エイワイファーマ株式会社&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 日本上市&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请参比制剂与国内已批准用法用量存在差异。审议未通过。<br /> 35-46&nbsp; &nbsp; &nbsp; &nbsp; 克拉霉素片&nbsp; &nbsp; Clarithromycin Tablets /Klacid&nbsp; &nbsp; 50mg&nbsp; &nbsp; 日本大正制药<br /> 株式会社/Taisho Pharmaceutical Co., Ltd.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 日本上市&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请参比制剂规格小于单次最小给药剂量，审议未通过。<br /> 35-47&nbsp; &nbsp; &nbsp; &nbsp; 左氧氟沙星滴眼液&nbsp; &nbsp; Levofloxacin Eye Drops/Oftaquix&nbsp; &nbsp; 0.5%（0.3ml:1.5mg）&nbsp; &nbsp; 参天制药<br /> 株式会社&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 英国上市&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请参比制剂与已发布原研进口参比制剂浓度相同，仅装量不同，审议未通过。<br /> 35-48&nbsp; &nbsp; &nbsp; &nbsp; 左氧氟沙星滴眼液&nbsp; &nbsp; Levofloxacin Eye Drops/Oftaquix&nbsp; &nbsp; 0.5%（0.5ml:2.5mg）&nbsp; &nbsp; 参天制药<br /> 株式会社&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 英国上市&nbsp; &nbsp; 同上。<br /> 35-49&nbsp; &nbsp; &nbsp; &nbsp; 西地那非达泊西汀片&nbsp; &nbsp; Sildenafil and Dapoxetine Tablet /Dapoxil&nbsp; &nbsp; 达泊西汀30mg、<br /> 西地那非50mg&nbsp; &nbsp; VİTALİS İLAÇ SAN. TİC. A.Ş.&nbsp; &nbsp; 未进口原研药品&nbsp; &nbsp; 土耳其<br /> 上市&nbsp; &nbsp; 经一致性评价专家委员会审议，拟申请参比制剂仅在土耳其上市，且未提供完整和充分的安全性、有效性数据。综上，审议未通过。 参比制剂 http://www.metu.cn/index.php?qa=713&qa_1=%E3%80%8A%E5%8C%96%E5%AD%A6%E4%BB%BF%E5%88%B6%E8%8D%AF%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E7%9B%AE%E5%BD%95%EF%BC%88%E7%AC%AC%E4%B8%89%E5%8D%81%E4%BA%94%E6%89%B9%EF%BC%89%E3%80%8B%E7%9A%84%E5%85%AC%E7%A4%BA%EF%BC%8C27%E4%B8%AA%E6%96%B0%E5%A2%9E%EF%BC%8C15%E5%A2%9E%E8%A1%A5&show=714#c714 Tue, 17 Nov 2020 12:48:58 +0000 http://www.metu.cn/index.php?qa=708&qa_1=%E6%9C%AC%E5%91%A8%E8%A5%BF%E7%8F%AD%E7%89%99%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E5%BA%93%E5%AD%98%E4%BF%A1%E6%81%AF <p><span style="color:#000000; font-family:&quot;lucida Grande&quot;,Verdana,&quot;Microsoft YaHei&quot;; font-size:14px">西班牙上市的IBRANCE一盒，效期很好07/2023，报价欧元3708</span></p> 参比制剂 http://www.metu.cn/index.php?qa=708&qa_1=%E6%9C%AC%E5%91%A8%E8%A5%BF%E7%8F%AD%E7%89%99%E5%8F%82%E6%AF%94%E5%88%B6%E5%89%82%E5%BA%93%E5%AD%98%E4%BF%A1%E6%81%AF Mon, 05 Oct 2020 14:01:56 +0000 http://www.metu.cn/index.php?qa=705&qa_1=%E6%97%A5%E6%9C%AC2020%E5%B9%B49%E6%9C%88%E4%BB%BD%E4%BA%BA%E6%B0%94%E8%AF%A2%E5%8D%95%E7%9A%84%E8%8D%AF%E5%93%81&show=706#c706 LYRICA Capsules 25mg Pregabalin Pfizer 100cap<br /> LYRICA Capsules 75mg Pregabalin Pfizer 100cap<br /> Meptin inhalation solution 0.3mL Procaterol Hydrochloride Otsuka 56units<br /> NESP INJECTION PLASTIC SYRINGE 60μg darbepoetin-alfa Kyowa Kirin 1 Syringe<br /> Radicut Inj.30mg Amp Edaravone Mitsubishi Tanabe 20ml10amp<br /> RAPIACTA for Intravenous Drip Infusion 300mg Peramivir Hydrate Shionogi 60ml* 1bag<br /> Sawacillin Capsules 250 Amoxicillin Hydrate LTL Pharma 100cab<br /> SIGMART Injection 12mg (Cold Chain) Nicorandil Chugai 10vial<br /> Somazon 10mg for Injection (cold chain) Mecasermin(Genetical Orphan Pacific 1vial<br /> Takepron INTRAVENOUS injection 30mg Lansoprazole Takeda Teva 10vials<br /> UNISIA Combination Tablets HD Candesartan Cilexetil Takeda Teva 100tab<br /> URIADEC Tablets 20mg Topiroxostat Sanwa Kagaku 100tab<br /> URSO tablets 50mg Ursodeoxycholic Acid Mitsubishi Tanabe 100tab<br /> Vagostigmin Injection 0.5mg Neostigmine Methylsulfate Shionogi 10amp<br /> Vagostigmin Injection 2mg Neostigmine Methylsulfate Shionogi 10amp<br /> Xofluza 10mg Baloxavir Marboxil Shionogi 10tab<br /> Xofluza 20mg Baloxavir Marboxil Shionogi 10tab<br /> Xtandi Tablets 80mg Enzalutamide Astellas pharma 28 tab<br /> Zafatek 100mg Trelagliptin Succinate Takeda 20tab<br /> Zafatek 50mg Trelagliptin Succinate Takeda 20tab 参比制剂 http://www.metu.cn/index.php?qa=705&qa_1=%E6%97%A5%E6%9C%AC2020%E5%B9%B49%E6%9C%88%E4%BB%BD%E4%BA%BA%E6%B0%94%E8%AF%A2%E5%8D%95%E7%9A%84%E8%8D%AF%E5%93%81&show=706#c706 Wed, 16 Sep 2020 11:38:36 +0000 http://www.metu.cn/index.php?qa=704&qa_1=%E9%97%AE%EF%BC%9A%E6%94%B9%E5%89%82%E5%9E%8B%E5%93%81%E7%A7%8D%E5%BF%85%E9%A1%BB%E5%BE%97%E4%BD%93%E7%8E%B0%E5%85%B7%E6%9C%89%E6%98%8E%E6%98%BE%E7%9A%84%E4%B8%B4%E5%BA%8A%E4%BC%98%E5%8A%BF%E5%90%97%EF%BC%9F%E4%B8%B4%E5%BA%8A%E4%BC%98%E5%8A%BF%E5%BA%94%E4%BD%93%E7%8E%B0%E5%9C%A8%E5%93%AA%E4%BA%9B%E6%96%B9%E9%9D%A2%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">改剂型品种必须得体现具有明显的临床优势吗？临床优势应体现在哪些方面？</strong></section><p style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">根据化药注册分类改革工作方案(2016年第51号)，改剂型品种属于改良型新药，与原剂型相比必须有明显的临床优势，主要体现在比原剂型在有效性、安全性等方面有优势。</span></p><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; color: rgb(62, 62, 62); font-family: monospace; letter-spacing: 0.54px; text-align: justify; overflow-wrap: break-word !important;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word !important;"><pre style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; font-size: 18px; letter-spacing: 0.54px; line-height: 25.6px;"></pre><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; font-size: 16px; line-height: 25.6px; white-space: normal;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; line-height: 25.6px;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word;"><pre style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; font-size: 18px; letter-spacing: 0.54px; line-height: 25.6px;"></pre><pre style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; letter-spacing: 0.54px; line-height: 25.6px;"></pre><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; font-size: 16px; line-height: 25.6px; white-space: normal;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; letter-spacing: 0.54px;"><pre style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; font-size: 18px; letter-spacing: 0.54px; line-height: 25.6px;"></pre><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; font-size: 16px; line-height: 25.6px; white-space: normal;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; line-height: 25.6px;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word;"><pre style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; font-size: 18px; letter-spacing: 0.54px; line-height: 25.6px;"></pre><pre style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; letter-spacing: 0.54px; line-height: 25.6px;"></pre><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; font-size: 16px; line-height: 25.6px; white-space: normal;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word; letter-spacing: 0.54px;"><p style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;"><strong style="box-sizing:border-box !important; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px"><span style="box-sizing:border-box !important; font-family:Helvetica,sans-serif; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">&nbsp;</span></strong></p></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section> 参比制剂 http://www.metu.cn/index.php?qa=704&qa_1=%E9%97%AE%EF%BC%9A%E6%94%B9%E5%89%82%E5%9E%8B%E5%93%81%E7%A7%8D%E5%BF%85%E9%A1%BB%E5%BE%97%E4%BD%93%E7%8E%B0%E5%85%B7%E6%9C%89%E6%98%8E%E6%98%BE%E7%9A%84%E4%B8%B4%E5%BA%8A%E4%BC%98%E5%8A%BF%E5%90%97%EF%BC%9F%E4%B8%B4%E5%BA%8A%E4%BC%98%E5%8A%BF%E5%BA%94%E4%BD%93%E7%8E%B0%E5%9C%A8%E5%93%AA%E4%BA%9B%E6%96%B9%E9%9D%A2%EF%BC%9F Tue, 08 Sep 2020 09:03:32 +0000 http://www.metu.cn/index.php?qa=703&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%A0%B7%E5%93%81-%E5%AF%B9%E7%85%A7%E5%93%81%E7%9A%84%E5%88%B6%E5%A4%87-%E9%80%89%E6%8B%A9%E4%B8%8E%E6%A3%80%E9%AA%8C%E6%9C%89%E4%BB%80%E4%B9%88%E8%A6%81%E6%B1%82%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">临床试验样品、对照品的制备、选择与检验有什么要求？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">临床试验样品应按照GCP中对试验药物管理相关条款及《药品注册管理办法》（28号令）第36条规定执行。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=703&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%A0%B7%E5%93%81-%E5%AF%B9%E7%85%A7%E5%93%81%E7%9A%84%E5%88%B6%E5%A4%87-%E9%80%89%E6%8B%A9%E4%B8%8E%E6%A3%80%E9%AA%8C%E6%9C%89%E4%BB%80%E4%B9%88%E8%A6%81%E6%B1%82%EF%BC%9F Tue, 08 Sep 2020 09:02:39 +0000 http://www.metu.cn/index.php?qa=702&qa_1=%E9%97%AE%EF%BC%9A%E5%9B%BD%E5%86%85%E9%A6%96%E5%AE%B6%E5%93%81%E7%A7%8D%E6%8A%A5%E7%94%9F%E4%BA%A7%E6%97%B6%E8%83%BD%E5%90%A6%E7%94%B3%E6%8A%A5%E5%95%86%E5%93%81%E5%90%8D%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">国内首家品种报生产时能否申报商品名？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">药品商品名的申报应符合《关于进一步规范药品名称管理的通知》（国食药监注[2006]99号）的要求。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=702&qa_1=%E9%97%AE%EF%BC%9A%E5%9B%BD%E5%86%85%E9%A6%96%E5%AE%B6%E5%93%81%E7%A7%8D%E6%8A%A5%E7%94%9F%E4%BA%A7%E6%97%B6%E8%83%BD%E5%90%A6%E7%94%B3%E6%8A%A5%E5%95%86%E5%93%81%E5%90%8D%EF%BC%9F Tue, 08 Sep 2020 09:02:10 +0000 http://www.metu.cn/index.php?qa=701&qa_1=%E9%97%AE%EF%BC%9A%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E4%BA%A7%E5%93%81%E5%B7%B2%E8%8E%B7%E5%BE%97%E4%B8%B4%E5%BA%8A%E6%89%B9%E4%BB%B6%EF%BC%8C%E5%B7%B2%E5%AE%8C%E6%88%90%E5%B7%A5%E8%89%BA%E6%94%B9%E8%BF%9B%E7%AD%89%E7%A0%94%E7%A9%B6%E5%B7%A5%E4%BD%9C%EF%BC%8C%E7%8E%B0%E6%8B%9F%E5%BC%80%E5%B1%95%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%EF%BC%8C%E6%98%AF%E5%90%A6%E5%BF%85%E9%A1%BB%E8%BF%9B%E8%A1%8C%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%E5%A4%87%E6%A1%88%E5%90%8E%E6%89%8D%E8%83%BD%E5%BC%80%E5%B1%95%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">口服固体制剂产品已获得临床批件，已完成工艺改进等研究工作，现拟开展生物等效性试验，是否必须进行生物等效性试验备案后才能开展？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">已获得临床试验批件且临床试验批件在有效期内的，可直接开展生物等效性试验，不必进行生物等效性试验备案。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=701&qa_1=%E9%97%AE%EF%BC%9A%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E4%BA%A7%E5%93%81%E5%B7%B2%E8%8E%B7%E5%BE%97%E4%B8%B4%E5%BA%8A%E6%89%B9%E4%BB%B6%EF%BC%8C%E5%B7%B2%E5%AE%8C%E6%88%90%E5%B7%A5%E8%89%BA%E6%94%B9%E8%BF%9B%E7%AD%89%E7%A0%94%E7%A9%B6%E5%B7%A5%E4%BD%9C%EF%BC%8C%E7%8E%B0%E6%8B%9F%E5%BC%80%E5%B1%95%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%EF%BC%8C%E6%98%AF%E5%90%A6%E5%BF%85%E9%A1%BB%E8%BF%9B%E8%A1%8C%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%E5%A4%87%E6%A1%88%E5%90%8E%E6%89%8D%E8%83%BD%E5%BC%80%E5%B1%95%EF%BC%9F Tue, 08 Sep 2020 09:01:49 +0000 http://www.metu.cn/index.php?qa=700&qa_1=%E9%97%AE%EF%BC%9A%E3%80%8A%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E6%80%BB%E5%B1%80%E5%85%B3%E4%BA%8E%E8%B0%83%E6%95%B4%E9%83%A8%E5%88%86%E8%8D%AF%E5%93%81%E8%A1%8C%E6%94%BF%E5%AE%A1%E6%89%B9%E4%BA%8B%E9%A1%B9%E5%AE%A1%E6%89%B9%E7%A8%8B%E5%BA%8F%E7%9A%84%E5%86%B3%E5%AE%9A%E3%80%8B%EF%BC%88%E6%80%BB%E5%B1%80%E4%BB%A4%E7%AC%AC31%E5%8F%B7%EF%BC%89%E5%8F%91%E5%B8%83%E5%90%8E%EF%BC%8C%E5%86%8D%E6%B3%A8%E5%86%8C%E6%9C%9F%E9%97%B4%E7%9A%84%E4%B8%B4%E6%97%B6%E8%BF%9B%E5%8F%A3%E6%98%AF%E5%90%A6%E4%B9%9F%E7%94%B1%E8%8D%AF%E5%AE%A1%E4%B8%AD%E5%BF%83%E5%AE%A1%E6%89%B9%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">《国家食品药品监督管理总局关于调整部分药品行政审批事项审批程序的决定》（总局令第31号）发布后，再注册期间的临时进口是否也由药审中心审批？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">临时进口申请不属于总局31号文调整审批程序的范围，应按原程序申报和审批。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=700&qa_1=%E9%97%AE%EF%BC%9A%E3%80%8A%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E6%80%BB%E5%B1%80%E5%85%B3%E4%BA%8E%E8%B0%83%E6%95%B4%E9%83%A8%E5%88%86%E8%8D%AF%E5%93%81%E8%A1%8C%E6%94%BF%E5%AE%A1%E6%89%B9%E4%BA%8B%E9%A1%B9%E5%AE%A1%E6%89%B9%E7%A8%8B%E5%BA%8F%E7%9A%84%E5%86%B3%E5%AE%9A%E3%80%8B%EF%BC%88%E6%80%BB%E5%B1%80%E4%BB%A4%E7%AC%AC31%E5%8F%B7%EF%BC%89%E5%8F%91%E5%B8%83%E5%90%8E%EF%BC%8C%E5%86%8D%E6%B3%A8%E5%86%8C%E6%9C%9F%E9%97%B4%E7%9A%84%E4%B8%B4%E6%97%B6%E8%BF%9B%E5%8F%A3%E6%98%AF%E5%90%A6%E4%B9%9F%E7%94%B1%E8%8D%AF%E5%AE%A1%E4%B8%AD%E5%BF%83%E5%AE%A1%E6%89%B9%EF%BC%9F Tue, 08 Sep 2020 09:01:29 +0000 http://www.metu.cn/index.php?qa=699&qa_1=%E9%97%AE%EF%BC%9A%E5%BE%85%E5%AE%A1%E8%AF%84%E5%93%81%E7%A7%8D%E5%B1%9E%E4%BA%8E%E5%BA%94%E8%BF%9B%E8%A1%8C%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E8%87%AA%E6%9F%A5%E6%A0%B8%E6%9F%A5%E8%8C%83%E5%9B%B4%E7%9A%84%EF%BC%8C%E4%BD%86-%E6%9C%AA%E6%A0%87%E8%AE%B0%E9%9C%80%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%A0%B8%E6%9F%A5%EF%BC%8C%E4%B9%9F%E6%9C%AA%E7%BA%B3%E5%85%A5%E6%80%BB%E5%B1%80%E5%85%AC%E5%91%8A%EF%BC%8C%E8%AF%A5%E5%A6%82%E4%BD%95%E5%A4%84%E7%90%86%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">待审评品种属于应进行临床试验数据自查核查范围的，但“申请人之窗”未标记需临床试验核查，也未纳入总局公告，该如何处理？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">发现此类情况，申请人可通过“申请人之窗”一般性技术问题咨询通道</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">提出，或邮件向项目管理人反映，或向药审中心提交公文说明。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=699&qa_1=%E9%97%AE%EF%BC%9A%E5%BE%85%E5%AE%A1%E8%AF%84%E5%93%81%E7%A7%8D%E5%B1%9E%E4%BA%8E%E5%BA%94%E8%BF%9B%E8%A1%8C%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E8%87%AA%E6%9F%A5%E6%A0%B8%E6%9F%A5%E8%8C%83%E5%9B%B4%E7%9A%84%EF%BC%8C%E4%BD%86-%E6%9C%AA%E6%A0%87%E8%AE%B0%E9%9C%80%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%A0%B8%E6%9F%A5%EF%BC%8C%E4%B9%9F%E6%9C%AA%E7%BA%B3%E5%85%A5%E6%80%BB%E5%B1%80%E5%85%AC%E5%91%8A%EF%BC%8C%E8%AF%A5%E5%A6%82%E4%BD%95%E5%A4%84%E7%90%86%EF%BC%9F Tue, 08 Sep 2020 09:01:10 +0000 http://www.metu.cn/index.php?qa=698&qa_1=%E9%97%AE%EF%BC%9A%E7%94%B3%E8%AF%B7%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E4%BC%9A%E8%AE%AE%E7%9A%84%E8%BF%9B%E5%BA%A6%E4%BB%A5%E5%8F%8A%E7%A8%8B%E5%BA%8F%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">申请沟通交流会议的进度以及程序？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">根据《总局关于发布药物研发与技术审评沟通交流管理办法（试行）》（2016年第94号），申请人可通过药审中心网站“申请人之窗”提交“沟通交流会议基本信息表”及“沟通交流会议资料”，药审中心项目管理人负责组织会议申请的审核、筹备沟通交流会议，确定日期、地点、内容、参会人员等信息。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=698&qa_1=%E9%97%AE%EF%BC%9A%E7%94%B3%E8%AF%B7%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E4%BC%9A%E8%AE%AE%E7%9A%84%E8%BF%9B%E5%BA%A6%E4%BB%A5%E5%8F%8A%E7%A8%8B%E5%BA%8F%EF%BC%9F Tue, 08 Sep 2020 09:00:45 +0000 http://www.metu.cn/index.php?qa=697&qa_1=%E9%97%AE%EF%BC%9A%E5%A6%82%E4%BD%95%E5%8F%98%E6%9B%B4%E5%BE%85%E5%AE%A1%E8%AF%84%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E7%9A%84%E8%81%94%E7%B3%BB%E4%BA%BA-%E5%85%AC%E5%8F%B8%E5%90%8D%E7%A7%B0%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px"><span style="box-sizing:border-box !important; color:#007aaa; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</span></strong><strong style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px"><span style="box-sizing:border-box !important; color:#007aaa; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">如何变更待审评注册申请的联系人、公司名称？</span></strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">根据食品药品监管总局《关于进一步规范药品注册受理工作的通知》（食药监药化管〔2015〕122号&nbsp;&nbsp;）&nbsp;&nbsp;，在审评过程中药品注册申请的申请人机构更名（主体不变）、联系方式变更（仅限于申请人联系电话、传真、电子邮箱地址的变更）、注册地址变更（不改变生产地址）、拟使用的商品名称增加或改变的，由原受理部门（省局注册处或总局受理中心）审核后通知药品技术审评部门。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=697&qa_1=%E9%97%AE%EF%BC%9A%E5%A6%82%E4%BD%95%E5%8F%98%E6%9B%B4%E5%BE%85%E5%AE%A1%E8%AF%84%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E7%9A%84%E8%81%94%E7%B3%BB%E4%BA%BA-%E5%85%AC%E5%8F%B8%E5%90%8D%E7%A7%B0%EF%BC%9F Tue, 08 Sep 2020 09:00:25 +0000 http://www.metu.cn/index.php?qa=696&qa_1=%E9%97%AE%EF%BC%9A%E5%A6%82%E4%BD%95%E5%9C%A8%E5%AE%A1%E8%AF%84%E8%BF%87%E7%A8%8B%E4%B8%AD%E8%A1%A5%E5%85%85%E7%A8%B3%E5%AE%9A%E6%80%A7%E7%A0%94%E7%A9%B6%E8%B5%84%E6%96%99%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px"><span style="box-sizing:border-box !important; color:#007aaa; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</span></strong><strong style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px"><span style="box-sizing:border-box !important; color:#007aaa; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">如何在审评过程中补充稳定性研究资料？</span></strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">对尚未完成审评的注册申请，申请人可以通过公文方式向药审中心补充提交稳定性研究数据；</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">对已完成审评的品种，不再接收此类资料。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=696&qa_1=%E9%97%AE%EF%BC%9A%E5%A6%82%E4%BD%95%E5%9C%A8%E5%AE%A1%E8%AF%84%E8%BF%87%E7%A8%8B%E4%B8%AD%E8%A1%A5%E5%85%85%E7%A8%B3%E5%AE%9A%E6%80%A7%E7%A0%94%E7%A9%B6%E8%B5%84%E6%96%99%EF%BC%9F Tue, 08 Sep 2020 09:00:06 +0000 http://www.metu.cn/index.php?qa=695&qa_1=%E9%97%AE%EF%BC%9A%E5%8F%91%E8%A1%A5%E9%80%9A%E7%9F%A5%E4%B8%AD%E8%A6%81%E6%B1%82%E8%BF%9B%E8%A1%8C%E8%B4%A8%E9%87%8F%E6%A0%87%E5%87%86%E5%A4%8D%E6%A0%B8%E6%88%96%E6%A3%80%E9%AA%8C%E6%97%B6%EF%BC%8C%E8%8D%AF%E5%93%81%E6%A3%80%E9%AA%8C%E6%9C%BA%E6%9E%84%E6%97%A0%E6%B3%95%E5%9C%A8%E8%A1%A5%E5%85%85%E8%B5%84%E6%96%99%E8%A7%84%E5%AE%9A%E6%9C%9F%E9%99%90%E5%86%85%E5%AE%8C%E6%88%90%E6%A3%80%E9%AA%8C%E5%B7%A5%E4%BD%9C%EF%BC%8C%E8%AF%A5%E5%A6%82%E4%BD%95%E5%A4%84%E7%90%86%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">发补通知中要求进行质量标准复核或检验时，药品检验机构无法在补充资料规定期限内完成检验工作，该如何处理？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">申请人应在补充资料规定的期限内向药审中心提交除检验报告（质量复核报告或检验报告）以外的其他资料、药品检验机构样品接收单，检验报告由检验机构在完成检验工作后报送药审中心，药审中心会在收到质量复核报告或检验报告后启动审评任务。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=695&qa_1=%E9%97%AE%EF%BC%9A%E5%8F%91%E8%A1%A5%E9%80%9A%E7%9F%A5%E4%B8%AD%E8%A6%81%E6%B1%82%E8%BF%9B%E8%A1%8C%E8%B4%A8%E9%87%8F%E6%A0%87%E5%87%86%E5%A4%8D%E6%A0%B8%E6%88%96%E6%A3%80%E9%AA%8C%E6%97%B6%EF%BC%8C%E8%8D%AF%E5%93%81%E6%A3%80%E9%AA%8C%E6%9C%BA%E6%9E%84%E6%97%A0%E6%B3%95%E5%9C%A8%E8%A1%A5%E5%85%85%E8%B5%84%E6%96%99%E8%A7%84%E5%AE%9A%E6%9C%9F%E9%99%90%E5%86%85%E5%AE%8C%E6%88%90%E6%A3%80%E9%AA%8C%E5%B7%A5%E4%BD%9C%EF%BC%8C%E8%AF%A5%E5%A6%82%E4%BD%95%E5%A4%84%E7%90%86%EF%BC%9F Tue, 08 Sep 2020 08:59:46 +0000 http://www.metu.cn/index.php?qa=694&qa_1=%E9%97%AE%EF%BC%9A%E5%AE%A1%E8%AF%84%E4%B8%8E%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E6%A0%B8%E6%9F%A5%E4%B9%8B%E9%97%B4%E7%9A%84%E5%85%88%E5%90%8E%E9%A1%BA%E5%BA%8F%E6%98%AF%E5%A6%82%E4%BD%95%E8%A1%94%E6%8E%A5%E7%9A%84%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">审评与临床试验数据核查之间的先后顺序是如何衔接的？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">临床核查按照总局《关于印发药物临床试验数据核查工作程序（暂行）的通知》(食药监药化管〔2016〕34号)执行。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">药审中心定期向总局核查中心更新需要临床试验数据核查的注册申请名单，其中纳入优先审评程序的建议作为第一优先级安排核查，已经完成各项审评工作等待汇总临床核查结果的建议作为第二优先级安排核查，其他注册申请则按序核查；</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">同一优先级的注册申请则建议按照注册申请转入药审中心的时间先后顺序安排核查。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=694&qa_1=%E9%97%AE%EF%BC%9A%E5%AE%A1%E8%AF%84%E4%B8%8E%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E6%A0%B8%E6%9F%A5%E4%B9%8B%E9%97%B4%E7%9A%84%E5%85%88%E5%90%8E%E9%A1%BA%E5%BA%8F%E6%98%AF%E5%A6%82%E4%BD%95%E8%A1%94%E6%8E%A5%E7%9A%84%EF%BC%9F Tue, 08 Sep 2020 08:59:26 +0000 http://www.metu.cn/index.php?qa=693&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%AD%E8%8D%AF%E5%88%B6%E5%89%82%E5%8F%AF%E5%90%A6%E7%94%A8%E8%A1%A5%E5%85%85%E7%94%B3%E8%AF%B7%E6%96%B9%E5%BC%8F%E5%9C%A8%E5%8E%9F%E6%9C%89%E7%B3%96%E5%9E%8B%E5%88%B6%E5%89%82%E5%9F%BA%E7%A1%80%E4%B8%8A%E5%A2%9E%E5%8A%A0%E6%97%A0%E7%B3%96%E5%9E%8B%E8%A7%84%E6%A0%BC%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">中药制剂可否用补充申请方式在原有糖型制剂基础上增加无糖型规格？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">中药制剂有糖型改为无糖型属于辅料的变更，不属于增加规格，两者只能保留其一，不能通过补充申请途径增加。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=693&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%AD%E8%8D%AF%E5%88%B6%E5%89%82%E5%8F%AF%E5%90%A6%E7%94%A8%E8%A1%A5%E5%85%85%E7%94%B3%E8%AF%B7%E6%96%B9%E5%BC%8F%E5%9C%A8%E5%8E%9F%E6%9C%89%E7%B3%96%E5%9E%8B%E5%88%B6%E5%89%82%E5%9F%BA%E7%A1%80%E4%B8%8A%E5%A2%9E%E5%8A%A0%E6%97%A0%E7%B3%96%E5%9E%8B%E8%A7%84%E6%A0%BC%EF%BC%9F Tue, 08 Sep 2020 08:58:43 +0000 http://www.metu.cn/index.php?qa=692&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%AD%E8%8D%AF%E4%B8%AD%E8%AF%95%E7%A0%94%E7%A9%B6%E6%A0%B7%E5%93%81%E7%9A%84%E5%88%B6%E5%A4%87%E6%98%AF%E5%90%A6%E9%9C%80%E8%A6%81%E5%9C%A8%E6%9C%89gmp%E8%AF%81%E4%B9%A6%E7%9A%84%E8%BD%A6%E9%97%B4%E7%94%9F%E4%BA%A7%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">中药中试研究样品的制备是否需要在有GMP证书的车间生产？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">对中试样品制备的车间，不要求必须有GMP证书。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=692&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%AD%E8%8D%AF%E4%B8%AD%E8%AF%95%E7%A0%94%E7%A9%B6%E6%A0%B7%E5%93%81%E7%9A%84%E5%88%B6%E5%A4%87%E6%98%AF%E5%90%A6%E9%9C%80%E8%A6%81%E5%9C%A8%E6%9C%89gmp%E8%AF%81%E4%B9%A6%E7%9A%84%E8%BD%A6%E9%97%B4%E7%94%9F%E4%BA%A7%EF%BC%9F Tue, 08 Sep 2020 08:58:22 +0000 http://www.metu.cn/index.php?qa=691&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%AD%E8%8D%AF%E5%A2%9E%E5%8A%A0%E9%80%82%E5%BA%94%E7%97%87%E6%88%96%E9%80%82%E7%94%A8%E4%BA%BA%E7%BE%A4%E7%AD%89%E9%9C%80%E8%A6%81%E5%BC%80%E5%B1%95%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%9A%84%E8%A1%A5%E5%85%85%E7%94%B3%E8%AF%B7%EF%BC%8C%E6%98%AF%E5%90%A6%E9%9C%80%E8%A6%81%E5%9C%A8%E7%AC%AC%E4%B8%80%E6%AC%A1%E6%8F%90%E4%BA%A4%E8%A1%A5%E5%85%85%E7%94%B3%E8%AF%B7%E7%9A%84%E6%97%B6%E5%80%99%E6%8F%90%E4%BA%A4%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">中药增加适应症或适用人群等需要开展临床试验的补充申请，是否需要在第一次提交补充申请的时候提交临床试验数据？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">第一次提交补充申请时不要求必须提交临床试验数据，经审评后如需开展临床试验的，由药审中心发出临床批件，申请人可在获得临床批件后开展临床试验，完成临床试验后按照补充申请再次申报。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=691&qa_1=%E9%97%AE%EF%BC%9A%E4%B8%AD%E8%8D%AF%E5%A2%9E%E5%8A%A0%E9%80%82%E5%BA%94%E7%97%87%E6%88%96%E9%80%82%E7%94%A8%E4%BA%BA%E7%BE%A4%E7%AD%89%E9%9C%80%E8%A6%81%E5%BC%80%E5%B1%95%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%9A%84%E8%A1%A5%E5%85%85%E7%94%B3%E8%AF%B7%EF%BC%8C%E6%98%AF%E5%90%A6%E9%9C%80%E8%A6%81%E5%9C%A8%E7%AC%AC%E4%B8%80%E6%AC%A1%E6%8F%90%E4%BA%A4%E8%A1%A5%E5%85%85%E7%94%B3%E8%AF%B7%E7%9A%84%E6%97%B6%E5%80%99%E6%8F%90%E4%BA%A4%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%EF%BC%9F Tue, 08 Sep 2020 08:58:02 +0000 http://www.metu.cn/index.php?qa=690&qa_1=%E9%97%AE%EF%BC%9A-%E7%94%B3%E8%AF%B7%E4%BA%BA%E4%B9%8B%E7%AA%97-%E6%98%BE%E7%A4%BA%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E5%B7%B2%E7%BB%8F%E5%AE%8C%E6%88%90%E6%8A%80%E6%9C%AF%E5%AE%A1%E8%AF%84%EF%BC%8C%E4%B8%BA%E4%BD%95%E4%B8%80%E7%9B%B4%E5%A4%84%E4%BA%8E%E6%96%87%E4%BB%B6%E5%88%B6%E4%BD%9C%E7%8A%B6%E6%80%81%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">“申请人之窗”显示注册申请已经完成技术审评，为何一直处于文件制作状态？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">为兼顾公平和效率，药审中心对注册申请实施同品种集中审评和按进中心时间先后顺序放行的管理方式，审评团队可不按申报顺序实施品种集中审评，完成审评后由业务管理处按同审评序列注册申请的申报时间顺序制作送签文件和放行。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">因此，申报时间靠后但先完成审评的注册申请，需等待排在其前面的任务完成后才能转入下一环节。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">纳入优先审评程序的注册申请不受按序放行的限制，各环节均应第一时间处理。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=690&qa_1=%E9%97%AE%EF%BC%9A-%E7%94%B3%E8%AF%B7%E4%BA%BA%E4%B9%8B%E7%AA%97-%E6%98%BE%E7%A4%BA%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E5%B7%B2%E7%BB%8F%E5%AE%8C%E6%88%90%E6%8A%80%E6%9C%AF%E5%AE%A1%E8%AF%84%EF%BC%8C%E4%B8%BA%E4%BD%95%E4%B8%80%E7%9B%B4%E5%A4%84%E4%BA%8E%E6%96%87%E4%BB%B6%E5%88%B6%E4%BD%9C%E7%8A%B6%E6%80%81%EF%BC%9F Tue, 08 Sep 2020 08:57:44 +0000 http://www.metu.cn/index.php?qa=689&qa_1=%E9%97%AE%EF%BC%9A%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E5%AE%A1%E8%AF%84%E6%9C%9F%E9%97%B4%E5%A6%82%E4%BD%95%E7%94%B3%E8%AF%B7%E6%92%A4%E5%9B%9E%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">注册申请审评期间如何申请撤回？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">国产注册申请应请向省局提出撤回申请，由省局把撤回申请和省局意见单一并转送药审中心；</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">进口注册申请应向总局提出撤回申请，由总局把撤回申请转药审中心。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=689&qa_1=%E9%97%AE%EF%BC%9A%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E5%AE%A1%E8%AF%84%E6%9C%9F%E9%97%B4%E5%A6%82%E4%BD%95%E7%94%B3%E8%AF%B7%E6%92%A4%E5%9B%9E%EF%BC%9F Tue, 08 Sep 2020 08:57:22 +0000 http://www.metu.cn/index.php?qa=688&qa_1=%E9%97%AE%EF%BC%9A%E8%BF%9B%E5%8F%A3%E8%8D%AF%E7%9A%84be%E8%AF%95%E9%AA%8C%E6%98%AF%E5%90%A6%E5%8F%AF%E4%BB%A5%E5%9C%A8be%E5%A4%87%E6%A1%88%E5%B9%B3%E5%8F%B0%E8%BF%9B%E8%A1%8C%E5%A4%87%E6%A1%88%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">进口药的BE试验是否可以在BE备案平台进行备案？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">符合《国家食品药品监督管理总局关于化学药生物等效性试验实行备案管理的公告》（2015年第257号）规定范围的进口药品注册申请可以进行BE备案。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=688&qa_1=%E9%97%AE%EF%BC%9A%E8%BF%9B%E5%8F%A3%E8%8D%AF%E7%9A%84be%E8%AF%95%E9%AA%8C%E6%98%AF%E5%90%A6%E5%8F%AF%E4%BB%A5%E5%9C%A8be%E5%A4%87%E6%A1%88%E5%B9%B3%E5%8F%B0%E8%BF%9B%E8%A1%8C%E5%A4%87%E6%A1%88%EF%BC%9F Tue, 08 Sep 2020 08:57:03 +0000 http://www.metu.cn/index.php?qa=687&qa_1=%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E4%BA%BA%E5%BC%80%E5%B1%95%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%E5%89%8D30%E5%A4%A9%EF%BC%8C%E5%BA%94%E5%BD%93%E5%9C%A8%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E6%80%BB%E5%B1%80%E6%8C%87%E5%AE%9A%E7%9A%84%E5%8C%96%E5%AD%A6%E8%8D%AFbe%E8%AF%95%E9%AA%8C%E5%A4%87%E6%A1%88%E4%BF%A1%E6%81%AF%E5%B9%B3%E5%8F%B0%E8%BF%9B%E8%A1%8C%E5%8C%96%E5%AD%A6%E8%8D%AFbe%E8%AF%95%E9%AA%8C%E5%A4%87%E6%A1%88%EF%BC%8C%E6%8C%89%E8%A6%81%E6%B1%82%E6%8F%90%E4%BA%A4%E5%A4%87%E6%A1%88%E8%B5%84%E6%96%99 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">《国家食品药品监督管理总局关于化学药生物等效性试验实行备案管理的公告》（2015年第257号）中“注册申请人开展生物等效性试验前30天，应当在国家食品药品监督管理总局指定的化学药BE试验备案信息平台进行化学药BE试验备案，按要求提交备案资料”中，30天是自然日还是工作日？</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">申请人在获得备案号后30天，如总局无意见即可自行开展BE试验吗？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">《国家食品药品监督管理总局关于化学药生物等效性试验实行备案管理的公告》（2015年第257号）中关于备案时间的30天要求为自然日，备案成功并获得备案号30天后企业即可自行开展试验。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=687&qa_1=%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E4%BA%BA%E5%BC%80%E5%B1%95%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%E5%89%8D30%E5%A4%A9%EF%BC%8C%E5%BA%94%E5%BD%93%E5%9C%A8%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E6%80%BB%E5%B1%80%E6%8C%87%E5%AE%9A%E7%9A%84%E5%8C%96%E5%AD%A6%E8%8D%AFbe%E8%AF%95%E9%AA%8C%E5%A4%87%E6%A1%88%E4%BF%A1%E6%81%AF%E5%B9%B3%E5%8F%B0%E8%BF%9B%E8%A1%8C%E5%8C%96%E5%AD%A6%E8%8D%AFbe%E8%AF%95%E9%AA%8C%E5%A4%87%E6%A1%88%EF%BC%8C%E6%8C%89%E8%A6%81%E6%B1%82%E6%8F%90%E4%BA%A4%E5%A4%87%E6%A1%88%E8%B5%84%E6%96%99 Tue, 08 Sep 2020 08:56:44 +0000 http://www.metu.cn/index.php?qa=686&qa_1=%E9%97%AE%EF%BC%9Abe%E8%AF%95%E9%AA%8C%E4%B8%AD%E7%94%B1%E4%BA%8E%E5%A5%B3%E6%80%A7%E5%8F%97%E8%AF%95%E8%80%85%E6%8B%9B%E5%8B%9F%E5%9B%B0%E9%9A%BE%EF%BC%8C%E5%8F%AF%E5%90%A6%E4%BB%85%E9%87%87%E7%94%A8%E7%94%B7%E6%80%A7%E5%8F%97%E8%AF%95%E8%80%85%E8%BF%9B%E8%A1%8Cbe%E8%AF%95%E9%AA%8C%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">BE试验中由于女性受试者招募困难，可否仅采用男性受试者进行BE试验？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究》指导原则对于受试者的规定：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">应涵盖一般人群的特征，包括年龄、性别等。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">如果研究药物拟用于两种性别的人群，一般情况下，受试者应有适当的性别比例。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=686&qa_1=%E9%97%AE%EF%BC%9Abe%E8%AF%95%E9%AA%8C%E4%B8%AD%E7%94%B1%E4%BA%8E%E5%A5%B3%E6%80%A7%E5%8F%97%E8%AF%95%E8%80%85%E6%8B%9B%E5%8B%9F%E5%9B%B0%E9%9A%BE%EF%BC%8C%E5%8F%AF%E5%90%A6%E4%BB%85%E9%87%87%E7%94%A8%E7%94%B7%E6%80%A7%E5%8F%97%E8%AF%95%E8%80%85%E8%BF%9B%E8%A1%8Cbe%E8%AF%95%E9%AA%8C%EF%BC%9F Tue, 08 Sep 2020 08:56:23 +0000 http://www.metu.cn/index.php?qa=685&qa_1=%E9%97%AE%EF%BC%9A%E6%8C%89%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%811%E7%B1%BB%E7%94%B3%E6%8A%A5%E7%9A%84%E5%93%81%E7%A7%8D%EF%BC%8C%E5%8F%96%E5%BE%97%E4%B8%B4%E5%BA%8A%E6%89%B9%E4%BB%B6%E5%90%8E%E2%85%A0%E6%9C%9F%E4%B8%B4%E5%BA%8A%E6%A0%B7%E5%93%81%E7%94%9F%E4%BA%A7%E6%97%B6%E5%8F%AF%E5%90%A6%E6%9B%B4%E6%8D%A2%E5%9F%B9%E5%85%BB%E5%9F%BA%E7%9A%84%E7%94%9F%E4%BA%A7%E5%8E%82%E5%AE%B6%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按生物制品1类申报的品种，取得临床批件后Ⅰ期临床样品生产时可否更换培养基的生产厂家？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">根据现有指导原则要求，如需更换培养基的生产厂申请人应重新申报。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=685&qa_1=%E9%97%AE%EF%BC%9A%E6%8C%89%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%811%E7%B1%BB%E7%94%B3%E6%8A%A5%E7%9A%84%E5%93%81%E7%A7%8D%EF%BC%8C%E5%8F%96%E5%BE%97%E4%B8%B4%E5%BA%8A%E6%89%B9%E4%BB%B6%E5%90%8E%E2%85%A0%E6%9C%9F%E4%B8%B4%E5%BA%8A%E6%A0%B7%E5%93%81%E7%94%9F%E4%BA%A7%E6%97%B6%E5%8F%AF%E5%90%A6%E6%9B%B4%E6%8D%A2%E5%9F%B9%E5%85%BB%E5%9F%BA%E7%9A%84%E7%94%9F%E4%BA%A7%E5%8E%82%E5%AE%B6%EF%BC%9F Tue, 08 Sep 2020 08:56:03 +0000 http://www.metu.cn/index.php?qa=684&qa_1=%E9%97%AE%EF%BC%9A%E7%8E%B0%E8%A1%8C%E3%80%8A%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%81%E7%94%9F%E4%BA%A7%E5%B7%A5%E8%89%BA%E8%BF%87%E7%A8%8B%E5%8F%98%E6%9B%B4%E7%AE%A1%E7%90%86%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E3%80%8B%E4%B8%BA2005%E5%B9%B4%E9%A2%81%E5%B8%83%E7%9A%84%EF%BC%8C%E6%9C%89%E5%85%B3%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%81%E7%94%9F%E4%BA%A7%E5%B7%A5%E8%89%BA%E8%BF%87%E7%A8%8B%E5%8F%98%E6%9B%B4%E6%98%AF%E5%90%A6%E6%9C%89%E5%85%B6%E4%BB%96%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E5%8F%AF%E4%BB%A5%E5%8F%82%E8%80%83%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">现行《生物制品生产工艺过程变更管理技术指导原则》为2005年颁布的，有关生物制品生产工艺过程变更是否有其他指导原则可以参考？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">有关生物制品生产工艺过程变更可参考ICH Q5E指南。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=684&qa_1=%E9%97%AE%EF%BC%9A%E7%8E%B0%E8%A1%8C%E3%80%8A%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%81%E7%94%9F%E4%BA%A7%E5%B7%A5%E8%89%BA%E8%BF%87%E7%A8%8B%E5%8F%98%E6%9B%B4%E7%AE%A1%E7%90%86%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E3%80%8B%E4%B8%BA2005%E5%B9%B4%E9%A2%81%E5%B8%83%E7%9A%84%EF%BC%8C%E6%9C%89%E5%85%B3%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%81%E7%94%9F%E4%BA%A7%E5%B7%A5%E8%89%BA%E8%BF%87%E7%A8%8B%E5%8F%98%E6%9B%B4%E6%98%AF%E5%90%A6%E6%9C%89%E5%85%B6%E4%BB%96%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E5%8F%AF%E4%BB%A5%E5%8F%82%E8%80%83%EF%BC%9F Tue, 08 Sep 2020 08:55:43 +0000 http://www.metu.cn/index.php?qa=683&qa_1=%E9%97%AE%EF%BC%9A%E7%94%A8%E4%BA%8E%E8%82%8C%E8%82%89%E6%B3%A8%E5%B0%84%E7%9A%84%E7%8B%82%E7%8A%AC%E7%97%85%E4%BA%BA%E5%85%8D%E7%96%AB%E7%90%83%E8%9B%8B%E7%99%BD2%E6%AD%A5%E7%97%85%E6%AF%92%E7%81%AD%E6%B4%BB%E5%B7%A5%E8%89%BA%E6%98%AF%E5%90%A6%E5%BF%85%E9%9C%80%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">用于肌肉注射的狂犬病人免疫球蛋白2步病毒灭活工艺是否必需？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">根据现有指导原则要求，需要采用2步病毒灭活工艺。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=683&qa_1=%E9%97%AE%EF%BC%9A%E7%94%A8%E4%BA%8E%E8%82%8C%E8%82%89%E6%B3%A8%E5%B0%84%E7%9A%84%E7%8B%82%E7%8A%AC%E7%97%85%E4%BA%BA%E5%85%8D%E7%96%AB%E7%90%83%E8%9B%8B%E7%99%BD2%E6%AD%A5%E7%97%85%E6%AF%92%E7%81%AD%E6%B4%BB%E5%B7%A5%E8%89%BA%E6%98%AF%E5%90%A6%E5%BF%85%E9%9C%80%EF%BC%9F Tue, 08 Sep 2020 08:55:23 +0000 http://www.metu.cn/index.php?qa=682&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E5%8E%9F%E8%BE%85%E5%8C%85%E5%85%B3%E8%81%94%E7%94%B3%E6%8A%A5%E7%9A%84%E5%88%B6%E5%89%82%E7%94%B3%E8%AF%B7%E8%A1%A8%E5%A1%AB%E6%8A%A5%E9%97%AE%E9%A2%98 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于原辅包关联申报的制剂申请表填报问题</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">申请人应在制剂申请表“同品种已被受理或同期申报的原料药、制剂或不同规格品种” &nbsp;项填写该制剂已被受理或关联审批的原料药、辅料、药包材、制剂或不同规格品种的受理号/登记号及名称。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">完成临床研究申请上市的申请，还需填写原临床申请受理号、临床试验批件号、临床试验登记号或生物等效性试验备案号等。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=682&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E5%8E%9F%E8%BE%85%E5%8C%85%E5%85%B3%E8%81%94%E7%94%B3%E6%8A%A5%E7%9A%84%E5%88%B6%E5%89%82%E7%94%B3%E8%AF%B7%E8%A1%A8%E5%A1%AB%E6%8A%A5%E9%97%AE%E9%A2%98 Tue, 08 Sep 2020 08:55:05 +0000 http://www.metu.cn/index.php?qa=681&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E8%87%AA%E6%9F%A5%E6%A0%B8%E6%9F%A5%E8%8C%83%E5%9B%B4%E9%97%AE%E9%A2%98 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于药物临床试验数据自查核查范围问题</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《总局关于调整药品注册受理工作的公告》（2017年第&nbsp; 134号）规定：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">“集中受理后，国家食品药品监督管理总局新受理的药品注册申请，根据药品技术审评中的需求，由国家食品药品监督管理总局食品药品审核查验中心统一组织全国药品注册检查资源实施现场检查，并不再列入2015年7月以来国家食品药品监督管理总局开展的药物临床试验数据自查核查范围。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">”集中受理前的注册申请，依然属于2015年7月以来国家食品药品监督管理总局开展的药物临床试验数据自查核查范围。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=681&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E8%87%AA%E6%9F%A5%E6%A0%B8%E6%9F%A5%E8%8C%83%E5%9B%B4%E9%97%AE%E9%A2%98 Tue, 08 Sep 2020 08:54:42 +0000 http://www.metu.cn/index.php?qa=680&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E6%9C%AA%E5%9C%A8%E5%9B%BD%E5%86%85%E4%B8%8A%E5%B8%82%E7%9A%84%E8%8D%AF%E6%A2%B0%E7%BB%84%E5%90%88%E4%BA%A7%E5%93%81%E7%9A%84%E7%94%B3%E6%8A%A5%E9%97%AE%E9%A2%98 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于未在国内上市的药械组合产品的申报问题</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于药械组合产品注册有关事宜的公告》（2009年第&nbsp;&nbsp;第16号）规定，拟申报注册的药械组合产品，如该类产品尚未在中国获准上市，申请人应当在申报注册前，向行政受理服务中心申请产品属性界定，根据产品属性审定意见，申报药品/医疗器械注册申请，并在申请表中注明“药械组合产品”。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">为引导申请人合理申报，总局定期公布药械组合产品的界定结果，申请人可进行参考。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=680&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E6%9C%AA%E5%9C%A8%E5%9B%BD%E5%86%85%E4%B8%8A%E5%B8%82%E7%9A%84%E8%8D%AF%E6%A2%B0%E7%BB%84%E5%90%88%E4%BA%A7%E5%93%81%E7%9A%84%E7%94%B3%E6%8A%A5%E9%97%AE%E9%A2%98 Tue, 08 Sep 2020 08:54:24 +0000 http://www.metu.cn/index.php?qa=679&qa_1=%E9%97%AE%EF%BC%9A%E6%8C%89%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%AE%A1%E7%90%86%E7%9A%84%E8%8D%AF%E6%A2%B0%E7%BB%84%E5%90%88%E4%BA%A7%E5%93%81%E6%9C%89%E5%93%AA%E4%BA%9B%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按医疗器械管理的药械组合产品有哪些？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于药械组合产品注册有关事宜的公告》（2009年第&nbsp;&nbsp;第16号）规定，带药物涂层的支架，带抗菌涂层的导管、含药避孕套、含药节育环等，属于以医疗器械为主的药械组合产品，按医疗器械进行注册管理。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=679&qa_1=%E9%97%AE%EF%BC%9A%E6%8C%89%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%AE%A1%E7%90%86%E7%9A%84%E8%8D%AF%E6%A2%B0%E7%BB%84%E5%90%88%E4%BA%A7%E5%93%81%E6%9C%89%E5%93%AA%E4%BA%9B%EF%BC%9F Tue, 08 Sep 2020 08:54:01 +0000 http://www.metu.cn/index.php?qa=678&qa_1=%E9%97%AE%EF%BC%9A%E6%8C%89%E8%8D%AF%E5%93%81%E7%AE%A1%E7%90%86%E7%9A%84%E8%8D%AF%E6%A2%B0%E7%BB%84%E5%90%88%E4%BA%A7%E5%93%81%E6%9C%89%E5%93%AA%E4%BA%9B%EF%BC%9F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按药品管理的药械组合产品有哪些？</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于药械组合产品注册有关事宜的公告》（2009年第&nbsp;&nbsp;第16号）规定，含抗菌、消炎药品的创口贴、中药外用贴敷类产品等，属于以药品为主的药械组合产品，按药品进行注册管理</span></section> 参比制剂 http://www.metu.cn/index.php?qa=678&qa_1=%E9%97%AE%EF%BC%9A%E6%8C%89%E8%8D%AF%E5%93%81%E7%AE%A1%E7%90%86%E7%9A%84%E8%8D%AF%E6%A2%B0%E7%BB%84%E5%90%88%E4%BA%A7%E5%93%81%E6%9C%89%E5%93%AA%E4%BA%9B%EF%BC%9F Tue, 08 Sep 2020 08:53:42 +0000 http://www.metu.cn/index.php?qa=677&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E6%A0%B9%E6%8D%AE%E8%8D%AF%E5%93%81%E6%89%B9%E5%87%86%E6%96%87%E4%BB%B6%E8%A6%81%E6%B1%82%E5%AE%8C%E6%88%90%E4%B8%8A%E5%B8%82%E5%90%8E%E7%9B%B8%E5%85%B3%E6%8A%80%E6%9C%AF%E7%A0%94%E7%A9%B6%E7%9A%84%E7%94%B3%E6%8A%A5%E6%96%B9%E5%BC%8F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于根据药品批准文件要求完成上市后相关技术研究的申报方式</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于进一步规范药品注册受理工作的通知》（2015年第&nbsp; 122号）要求，此类情形应按补充申请申报，按照《药品注册管理办法》附件4药品补充申请注册事项第18项办理。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=677&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E6%A0%B9%E6%8D%AE%E8%8D%AF%E5%93%81%E6%89%B9%E5%87%86%E6%96%87%E4%BB%B6%E8%A6%81%E6%B1%82%E5%AE%8C%E6%88%90%E4%B8%8A%E5%B8%82%E5%90%8E%E7%9B%B8%E5%85%B3%E6%8A%80%E6%9C%AF%E7%A0%94%E7%A9%B6%E7%9A%84%E7%94%B3%E6%8A%A5%E6%96%B9%E5%BC%8F Tue, 08 Sep 2020 08:53:24 +0000 http://www.metu.cn/index.php?qa=676&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E5%B7%B2%E4%B8%8A%E5%B8%82%E7%9C%BC%E7%94%A8%E5%88%B6%E5%89%82%E5%A2%9E%E5%8A%A0%E5%8D%95%E5%89%82%E9%87%8F%E8%A3%85%E9%87%8F%E8%A7%84%E6%A0%BC%E7%9A%84%E7%94%B3%E6%8A%A5%E6%96%B9%E5%BC%8F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于已上市眼用制剂增加单剂量装量规格的申报方式</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于进一步规范药品注册受理工作的通知》（2015年第&nbsp; 122号）要求，眼用制剂申请变更最小制剂单位装量，应按补充申请申报，按照《药品注册管理办法》附件4药品补充申请注册事项第5项的程序和要求办理。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=676&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E5%B7%B2%E4%B8%8A%E5%B8%82%E7%9C%BC%E7%94%A8%E5%88%B6%E5%89%82%E5%A2%9E%E5%8A%A0%E5%8D%95%E5%89%82%E9%87%8F%E8%A3%85%E9%87%8F%E8%A7%84%E6%A0%BC%E7%9A%84%E7%94%B3%E6%8A%A5%E6%96%B9%E5%BC%8F Tue, 08 Sep 2020 08:52:36 +0000 http://www.metu.cn/index.php?qa=675&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E7%94%B3%E8%AF%B7%E6%A0%B8%E9%94%80%E5%95%86%E5%93%81%E5%90%8D%E7%A7%B0%E7%9A%84%E7%94%B3%E6%8A%A5%E6%96%B9%E5%BC%8F <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于申请核销商品名称的申报方式</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于进一步规范药品注册受理工作的通知》（2015年第&nbsp; 122号）要求，应按补充申请申报，按照《药品注册管理办法》附件药品补充注册申请注册事项第36项办理，并应符合《关于办理撤销商品名补充申请有关事项的通知》（食药监办注[2012]130号）相关要求.</span></section> 参比制剂 http://www.metu.cn/index.php?qa=675&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E7%94%B3%E8%AF%B7%E6%A0%B8%E9%94%80%E5%95%86%E5%93%81%E5%90%8D%E7%A7%B0%E7%9A%84%E7%94%B3%E6%8A%A5%E6%96%B9%E5%BC%8F Tue, 08 Sep 2020 08:52:11 +0000 http://www.metu.cn/index.php?qa=674&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E5%AE%A1%E8%AF%84%E8%BF%87%E7%A8%8B%E4%B8%AD%E8%81%94%E7%B3%BB%E6%96%B9%E5%BC%8F%E5%8F%98%E6%9B%B4%E7%9A%84%E5%8A%9E%E7%90%86 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于审评过程中联系方式变更的办理</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">按照《关于进一步规范药品注册受理工作的通知》（2015年第&nbsp; 122号）要求，在审评过程中，药品注册申请的申请人机构更名（主体不变）、联系方式变更（仅限于申请人联系电话、传真、电子邮箱地址的变更）、注册地址变更（不改变生产地址）、拟使用商品名称增加或改变的，由原受理部门审核后通知药品技术审评机构。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=674&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E5%AE%A1%E8%AF%84%E8%BF%87%E7%A8%8B%E4%B8%AD%E8%81%94%E7%B3%BB%E6%96%B9%E5%BC%8F%E5%8F%98%E6%9B%B4%E7%9A%84%E5%8A%9E%E7%90%86 Tue, 08 Sep 2020 08:51:44 +0000 http://www.metu.cn/index.php?qa=673&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%99%BB%E8%AE%B0%E4%B8%8E%E4%BF%A1%E6%81%AF%E5%85%AC%E7%A4%BA%E7%9A%84%E8%A6%81%E6%B1%82 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于临床试验登记与信息公示的要求</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">凡在我国进行的临床试验（含生物等效性试验、药代动力学试验、I、Ⅱ、Ⅲ、Ⅳ期试验等）的，均应登陆信息平台，按要求进行临床试验登记与信息公示。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">已开展临床试验的申请，提出后续注册申请时应同时提交按照《关于药物临床试验信息平台的公告》（第28号）要求已进行临床试验登记与信息公示的相关材料。</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">符合257号公告的生物等效性试验，应按照要求在相应平台进行备案。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=673&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%99%BB%E8%AE%B0%E4%B8%8E%E4%BF%A1%E6%81%AF%E5%85%AC%E7%A4%BA%E7%9A%84%E8%A6%81%E6%B1%82 Tue, 08 Sep 2020 08:51:25 +0000 http://www.metu.cn/index.php?qa=672&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E8%BF%9B%E5%8F%A3%E4%BA%A7%E5%93%81%E5%A4%9A%E4%B8%AA%E5%8C%85%E8%A3%85%E5%8E%82%E7%9A%84%E7%94%B3%E6%8A%A5 <section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">问：</strong><strong style="box-sizing:border-box !important; color:#007aaa; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">关于进口产品多个包装厂的申报</strong></section><section style="margin: 0px 8px 10px; padding: 0px; max-width: 100%; text-align: justify; letter-spacing: 0.544px; widows: 1; color: rgb(106, 104, 104); min-height: 1em; font-family: -apple-system-font, system-ui, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif; line-height: 1.75em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">解答：</span><span style="box-sizing:border-box !important; font-family:微软雅黑; font-size:15px; letter-spacing:0.544px; margin:0px; max-width:100%; overflow-wrap:break-word !important; padding:0px">申请人可在申请表中机构3（进口药品国外包装厂）一栏可填写多个包装厂名称和地址，各包装厂中间用分号间隔以示区别。</span></section> 参比制剂 http://www.metu.cn/index.php?qa=672&qa_1=%E9%97%AE%EF%BC%9A%E5%85%B3%E4%BA%8E%E8%BF%9B%E5%8F%A3%E4%BA%A7%E5%93%81%E5%A4%9A%E4%B8%AA%E5%8C%85%E8%A3%85%E5%8E%82%E7%9A%84%E7%94%B3%E6%8A%A5 Tue, 08 Sep 2020 08:50:54 +0000