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国家药监局:加强应急审批新冠肺炎病毒检测试剂上市後监管
阿思达克 03-31 07:38
国家药监局发布中国对新型冠状病毒检测试剂和防护用品的监管要求及标准,其中要求,加强应急审批新冠肺炎病毒检测试剂上市後监管。

同时,结合注册审批进展,及时要求相关省局切实加强对应急审批新冠肺炎病毒检测试剂生产企业的监督检查,监督企业严格落实主体责任,认真履行有关规定要求,严格按照产品技术要求组织生产,保证质量管理体系有效运行,认真开展不良事件监测,及时跟踪产品使用情况,确保产品质量安全。

国家药监局透露,截至2020年3月30日,国家药品监督管理局应急审批批准23个新冠病毒检测试剂,其中包括15个核酸检测试剂,8个抗体检测试剂。(ta/w) ~

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