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國家藥監局就「規範人源性幹細胞產品研究」徵求意見 進一步規範研發
據國家藥品監督管理局藥品審評中心公布,為規範和引導人源性幹細胞產品的藥學研究,國家藥品監督管理局藥品審評中心在前期調研的基礎上,結合國內外相關法規和技術要求,以及對這類產品當前技術發展和科學的認知,形成了《人源性幹細胞產品藥學研究與評價技術指導原則(徵求意見稿)》並向社會公開徵求意見。 據文件,2017年,原國家食品藥品監督管理總局發布《細胞治療產品研究與評價技術指導原則(試行)》,對細胞治療產品按照藥品管理相關法律法規進行研發時的技術要求進行了總體闡述。為進一步規範和指導幹細胞產品的藥學研發和申報,促進幹細胞產業發展,定下技術指導原則。
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