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一致性評價
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【為何要做一致性評價】
?    根據《國家藥品安全“十二五”規劃》,國家食品藥品監督管理局明確指出要求通過一致性評價全面提高仿制藥質量;
?    通過一致性評價的品種招標加分;
?    通過一致性評價的CFDA向社會公布;
?    企業可在說明書、標簽中標識;
?    社保部門在醫保支付方面予以適當支持;
?    醫療機構優先采購并在臨床中使用;
?    發改委、工業和信息化部給予支持;
?    同一品種達到3家以上通過一致性評價的,在集中采購等方面不再選用未通過一致性評價的品種。


【一致性評價基本要求】


《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》國辦發〔2016〕8號2016年03月05日

總局辦公廳公開征求關于落實《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》的有關事項的意見2016年04月08日

評價范圍

化學藥品新注冊分類實施前批準上市的仿制藥,凡未按照與原研藥品質量和療效一致原則審批的,均須開展一致性評價。

(一)化學藥品新注冊分類實施前批準上市的仿制藥,包括國產仿制藥、進口仿制藥和原研藥品地產化品種,均須開展一致性評價。

期限

國家基本藥物目錄(2012年版)中2007年10月1日前批準上市的化學藥品仿制藥口服固體制劑,應在2018年底前完成一致性評價,其中需開展臨床有效性試驗和存在特殊情形的品種,應在2021年底前完成一致性評價;逾期未完成的,不予再注冊。

化學藥品新注冊分類實施前批準上市的其他仿制藥,自首家品種通過一致性評價后,其他藥品生產企業的相同品種原則上應在3年內完成一致性評價;逾期未完成的,不予再注冊。

(二)凡2007年10月1日前批準上市的列入國家基本藥物目錄(2012年版)中的化學藥品仿制藥口服固體制劑(附件),原則上應在2018年底前完成一致性評價。

(三)上述第(二)款以外的化學藥品仿制口服固體制劑,自第一家通過一致性評價后,三年后不再受理其他藥品生產企業的同品種一致性評價申請。



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