基于人用经验的中药复方制剂新药临床研发指导原则(试行)

2022-04-29 国家药品监督管理局药品审评中心(CDE) 国家药品监督管理局药品审评中心 发表于加利福尼亚

为推动构建中医药理论、人用经验和临床试验相结合的中药注册审评证据体系,在国家药品监督管理局的部署下,药审中心组织制定了《基于人用经验的中药复方制剂新药临床研发指导原则(试行)》。根据《国家药监局综合司

中文标题:

基于人用经验的中药复方制剂新药临床研发指导原则(试行)

发布日期:

2022-04-29

简要介绍:

为推动构建中医药理论、人用经验和临床试验相结合的中药注册审评证据体系,在国家药品监督管理局的部署下,药审中心组织制定了《基于人用经验的中药复方制剂新药临床研发指导原则(试行)》。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》(药监综药管〔2020〕9号)要求,经国家药品监督管理局审查同意,现予发布,自发布之日起施行。

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    2022-05-02 1064510_1039
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    2022-05-01 小白努力长高高

    谢谢分享,了解了!!!

    0

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    2022-05-01 小白努力长高高

    谢谢分享,学习了

    0