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[法律法規] 關于生物制品需要關聯審評嗎？

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樓主

发表于 2018-8-22 14:27:27 | 只看該作者 |只看大圖回帖奖励

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我们生产溶瘤病毒类生物制品，生物新药品种請问做关联审评吗？读法规都蒙圈了

這裏說在中華人民共和國境內研制、生産、進口和使用的藥包材、藥用輔料，適用本公告要求。进口药品中所用的药包材、药用辅料按照《药品注冊管理办法》的相关规定执行。言外之意就是包括生物制品了，但是

里面说药品注冊申請人在中华人民共和国境内提出的注冊分类2.2、2.3、2.4、3、4、5类药品制剂申請所使用的原料药，以及各类药品注冊申請所使用的药用辅料、药包材适用于本公告要求。这明显是化药分类原则，

我蒙圈了，到底怎麽辦，有高人給我詳細解答一下嗎？這兩個公告是不是有沖突啊？

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堯甯靜森林

沙發

发表于 2018-8-22 14:59:20 | 只看該作者

沒什麽沖突啊，因爲生物制品沒有原料藥，所以原料藥當然是指化藥分類的啦。

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堯甯靜森林

板凳

发表于 2018-8-22 15:02:01 | 只看該作者

生物制品所用的輔料和藥包材適用于2017年發布的那份，有沖突的以2017年版的爲准（好像公告裏有提到）

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地板

发表于 2019-1-17 10:04:49 | 只看該作者

堯甯靜森林发表于 2018-8-22 15:02
生物制品所用的輔料和藥包材適用于2017年發布的那份，有沖突的以2017年版的爲准（好像公告裏有提到）

生物制品的辅料和药包材需要关联审评，那原液生产过程中使用的原料药药用辅料等就不需要关联审评了？那不需要如何控制？按三部进行质量控制？可是三部的质量控制里也包含上市许可，是包含注冊批件的，可是以后又取消原辅包的注冊了，该登记制，那不还得关联审评么？蒙了。。。

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