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

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：

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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66.pdf

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2021-12-13 137*****173<手机用户>

棒棒哒

106 0 举报
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2021-08-29 ms5000000287314931

很不错

122 0 举报
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2021-08-29 ms4000001350683783

积分

121 0 举报
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2021-08-29 ms5000000668334664

学习学习

109 0 举报
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2021-08-28 1209e435m98(暂无昵称)

学习了，谢谢分享

125 0 举报

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