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關于注射劑一致性評價補充資料相關事宜的通知

來源:CFDE  發布時間:2020-10-21  瀏覽量:1205

關于注射劑一致性評價補充資料相關事宜的通知

發布日期:20201021

       化學仿制藥注射劑一致性評價工作開展以來,部分注射劑一致性評價品種注冊申報資料缺陷明顯,與相關的指導原則要求差距較大,需補充開展大量新的研究工作。為落實《藥品注冊管理辦法》(2020年總局第27號令)相關要求,進一步提高注射劑一致性評價工作效率,優化審評審批流程,現就相關事宜通知如下:
       1. 按照《藥品注冊管理辦法》,書面補充資料需在80日內補回,逾期不能按要求提交全部補充資料的,將不予批準。
       2. 中心對于補充資料存在實質性缺陷的,將按不批準處理,不再進行第二次發補。
       3. 申請人可主動撤回申請,自行完善相關研究后重新申報。
                                                                                                                           國家藥品監督管理局藥品審評中心
                                                                                                                                         2020年10月21日

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