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國家藥監局藥審中心關于發布《藥品注冊申報資料格式體例與整理規范》的通告(2020年第12號)

來源:CFDE  發布時間:2020-07-09  瀏覽量:1928

國家藥監局藥審中心關于發布《藥品注冊申報資料格式體例與整理規范》的通告(2020年第12號)

發布日期:20200709

      根據《國家藥監局關于實施<藥品注冊管理辦法>有關事宜的公告》(2020年第46號),為推進相關配套規范性文件、技術指導原則起草制定工作,在國家藥品監督管理局的部署下,藥審中心組織制定了《藥品注冊申報資料格式體例與整理規范》(見附件),經國家藥品監督管理局審核同意,現予發布,自2020年10月1日起施行。
       特此通告。
                                                                                                                           國家藥品監督管理局藥品審評中心
                                                                                                                                         2020年7月8日

       附件1:藥品注冊申報資料格式體例與整理規范

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