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關于公開征求ICH《Q12:藥品生命周期管理的技術和監管考慮》及附件中文翻譯稿意見的通知

來源:CFDE  發布時間:2020-06-03  瀏覽量:2446

 關于公開征求ICH《Q12:藥品生命周期管理的技術和監管考慮》及附件中文翻譯稿意見的通知

發布日期:20200603

      為推動ICH指導原則在國內轉化實施,我中心組織翻譯了ICH《Q12:藥品生命周期管理的技術和監管考慮》及其附件(詳見通知附件),現對中文翻譯稿公開征求意見,為期1個月。
       如有修改意見,請反饋至聯系人電子郵箱:gkzhqyj@cde.org.cn。
                                                                                                                          

                                                                                                                           國家藥品監督管理局藥品審評中心
                                                                                                                                         2020年6月3日

附件1:Q12英文原文

附件2:Q12:藥品生命周期管理的技術和監管考慮(中文翻譯公開征求意見稿)

附件3:Q12附件英文原文

附件4:Q12附件(中文翻譯公開征求意見稿)


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