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國家藥監局藥審中心關于發布《藥物臨床試驗適應性設計指導原則(試行)》的通告(2021年第6號)

來源:NMPA CDE  發布時間:2021-01-29  瀏覽量:725

國家藥監局藥審中心關于發布《藥物臨床試驗適應性設計指導原則(試行)》的通告(2021年第6號)

發布日期:20210129

       為規范和統一國內對適應性設計的認識,促進適應性設計的應用和理解以提高研發效率,藥審中心組織制定了《藥物臨床試驗適應性設計指導原則(試行)》(見附件)。根據《國家藥監局綜合司關于印發藥品技術指導原則發布程序的通知》(藥監綜藥管〔2020〕9號)要求,經國家藥品監督管理局審查同意,現予發布,自發布之日起施行。
       特此通告。

       附件1:藥物臨床試驗適應性設計指導原則(試行)

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