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ICH指导原则《S12：基因治疗产品的生物分布研究》(step 3征求意见)

2021-08-11 国家药品监督管理局药品审评中心（CDE） CDE

基因治疗

ICH指导原则《S12：基因治疗产品的生物分布研究》现进入第3阶段征求意见。按照ICH相关章程要求，ICH监管机构成员需收集本地区关于第2b阶段指导原则草案的意见并反馈ICH。

中文标题：

ICH指导原则《S12：基因治疗产品的生物分布研究》(step 3征求意见)

发布机构：

国家药品监督管理局药品审评中心（CDE）

发布日期：

2021-08-11

简要介绍：

 ICH指导原则《S12：基因治疗产品的生物分布研究》现进入第3阶段征求意见。按照ICH相关章程要求，ICH监管机构成员需收集本地区关于第2b阶段指导原则草案的意见并反馈ICH。
       S12草案的原文和译文见附件，现就该指导原则及中文翻译稿向社会公开征求意见。

原始英文见：【英文】ICH_S12_Step2_DraftGuideline.pdf

相关资料下载：
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    2021-12-13 137*****173<手机用户>

    棒棒哒

    0

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    2021-08-29 ms5000000287314931

    很不错

    0

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    2021-08-29 ms4000001350683783

    积分

    0

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    2021-08-29 ms5000000668334664

    学习学习

    0

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    2021-08-28 1209e435m98(暂无昵称)

    学习了，谢谢分享

    0

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