CDE发布《药物临床试验中心化监查统计指导原则(征求意见稿)》公开征求意见通知

2021-09-17 CDE CDE

9月16日,国家药监局药审中心(CDE)发布《药物临床试验中心化监查统计指导原则(征求意见稿)》并公开征求意见通知。

9月16日,国家药监局药审中心(CDE)发布《药物临床试验中心化监查统计指导原则(征求意见稿)》并公开征求意见通知。通知称,这是为了呼应 ICH E6(R2)和我国药品监督管理局2020年发布的《药物临床试验质量管理规范》中均明确提出申办者应采用系统的、基于风险的方式对临床试验进行监查,并强调了中心化监查的优势。这将指导申办者对中心化监查的实践与应用,促进临床试验质量核查更加高效。

 
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       ICH E6(R2)和我国药品监督管理局2020年发布的《药物临床试验质量管理规范》中均明确提出申办者应采用系统的、基于风险的方式对临床试验进行监查,并强调了中心化监查的优势。为了指导申办者对中心化监查的实践与应用,促进临床试验质量核查更加高效。我中心组织起草了《药物临床试验中心化监查统计指导原则(征求意见稿)》,现公开征求意见。欢迎社会各界提出宝贵意见和建议,并请及时反馈给我们。

       征求意见时限为自发布之日起1个月。

       请将您的反馈意见发到邮箱:王北琪 wangbq@cde.org.cn

       感谢您的参与和大力支持。

                                                                                                                                                            国家药品监督管理局药品审评中心

                                                                                                                                                                            2021年9月16日

 

参考资料:https://www.cde.org.cn/main/news/viewInfoCommon/e83d165520d9ab17004eb10ff39d2c24

 

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    2021-09-18 查查佳佳

    你记错计算机死咯**片子

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