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國家藥監局:加強應急審批新冠肺炎病毒檢測試劑上市後監管
阿思達克 03-31 07:38
國家藥監局發布中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準,其中要求,加強應急審批新冠肺炎病毒檢測試劑上市後監管。

同時,結合註冊審批進展,及時要求相關省局切實加強對應急審批新冠肺炎病毒檢測試劑生產企業的監督檢查,監督企業嚴格落實主體責任,認真履行有關規定要求,嚴格按照產品技術要求組織生產,保證質量管理體系有效運行,認真開展不良事件監測,及時跟蹤產品使用情況,確保產品質量安全。

國家藥監局透露,截至2020年3月30日,國家藥品監督管理局應急審批批准23個新冠病毒檢測試劑,其中包括15個核酸檢測試劑,8個抗體檢測試劑。(ta/w) ~

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