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藥監局加強保健食品人體試食試驗管理工作

時間:2009-10-19  來源:未知  作者:山東新稀寶  點擊:

    為貫徹落實《食品安全法》對保健食品實行嚴格監管的要求,規范和加強保健食品人體試食試驗管理工作,國家藥監局現就有關工作通知如下:

    一、保健食品產品注冊申報資料中應當增加倫理委員會出具的允許開展該人體試食試驗證明文件的復印件。復印件須加蓋檢驗機構印鑒,附于人體試食試驗報告后。

    二、6月20日前已受理的產品,涉及人體試食試驗的,申請人應當向國家食品藥品監督管理局保健食品審評中心補交上述證明文件的復印件;自6月20日起受理的保健食品,申報資料中應當包含該證明文件。

    三、各省級局要進一步加強對保健食品注冊申報資料的形式審查。國家局保健食品審評中心要加強對產品醫學倫理資料的審核,嚴把技術審評關。

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