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CFDA發布一致性評價臨床有效性試驗一般考慮的通告

2017/02/24

來源:藥研發             時間:2017.2.8

為規范仿制藥質量和療效一致性評價工作,CFDA發布了《關于落實〈國務院辦公廳關于開展仿制藥質量和療效一致性評價的意見〉有關事項的公告》(2016年第106號)。文件提出,仿制藥一致性評價應合理選用評價方法。原則上應采用體內生物等效性試驗的方法進行一致性評價。找不到或無法確定參比制劑的,由藥品生產企業開展臨床有效性試驗。


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