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    陜西省大幅壓縮藥品 GMP認證時限
    日期:2019-07-02 07:53:40  來源:陜西傳媒網(陜西日報)    字號: T | T

      6月27日,記者從陜西省藥品監管局獲悉,為進一步推進“放管服”改革,該局日前出臺《陜西省藥品生產質量管理規范認證管理若干規定》(以下簡稱《規定》),優化藥品GMP認證工作流程。
     
      《規定》指出,7月6日起,陜西省藥品生產質量管理規范(藥品GMP)認證由145個工作日壓縮至63個工作日完成;省藥品監管局生產監管處將負責全省藥品GMP認證管理工作。
     
      《規定》明確了申請藥品GMP認證的生產企業需要提交的資料、現場檢查組人員組成、主要職責和人員分工等事項;進一步細化了認證程序,明確指出檢查組應形成現場檢查報告,藥品技術審核查驗中心需結合企業整改情況,按照國家對藥品生產現場檢查風險評定指導原則,對現場檢查報告進行綜合評定,并進行公示;公示期滿后,檢查組將綜合評定意見和相關材料報省藥品監管局生產監管處,由生產監管處對藥品技術審核查驗中心的綜合評定和相關材料進行行政審核審批。
     
      《規定》強調,申請認證企業或利益關系人不得向工作人員(含檢查員及專家)饋送禮金、禮品、支付憑證和有價證券等;工作人員不得以各種名義向申請認證企業或利益關系人吃拿卡要和報銷費用,嚴格執行認證工作紀律。(徐穎 張偉峰 瞿健蓬)
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