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關于化學原料藥申報資料有關事宜的通知

來源:NMPA CDE  發布時間:2020-01-13  瀏覽量:1858

 

      關于化學原料藥申報資料有關事宜的通知

發布日期:20200113

       按照《國家藥監局關于進一步完善藥品關聯審評審批和監管工作有關事宜的公告》(2019年第56號)要求,對于因特殊原因無法在平臺登記的原輔包,也可在藥品制劑注冊申請時,由藥品制劑注冊申請人一并提供原輔包研究資料。目前,部分申請人存在原料藥部分申報資料滯后遞交影響了審評進度的情況,為確保資料的完整性,提高審評效率,現再次明確藥品制劑注冊申請人在遞交申請時,應嚴格按照《M4:人用藥物注冊申請通用技術文檔(CTD)》或《關于發布化學藥品新注冊分類申報資料要求(試行)的通告》(2016年第80號)要求遞交完整的申報資料。
       特此通知。
                                                                                                                           國家藥品監督管理局藥品審評中心
                                                                                                                                         2020年1月13日

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