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《用于产生真实世界证据的真实世界数据指导原则（试行）》

2021-04-15 国家药品监督管理局药品审评中心（CDE） 国家药品监督管理局药品审评中心

真实世界数据真实世界研究

为进一步指导和规范申办者利用真实世界数据生成真实世界证据支持药物研发，药审中心组织制定了《用于产生真实世界证据的真实世界数据指导原则（试行）》（见附件）。根据《国家药监局综合司关于印发药品

中文标题：

《用于产生真实世界证据的真实世界数据指导原则（试行）》

发布机构：

国家药品监督管理局药品审评中心（CDE）

发布日期：

2021-04-15

简要介绍：

 为进一步指导和规范申办者利用真实世界数据生成真实世界证据支持药物研发，药审中心组织制定了《用于产生真实世界证据的真实世界数据指导原则（试行）》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。
       特此通告。
                                                                                                                           国家药品监督管理局药品审评中心

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《用于产生真实世界证据的真实世界数据指导原则（试行）》.pdf
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    2021-08-19 ms2000000690830510

    如何下载到呢

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1009506, encodeId=939a100950666, content=如何下载到呢, beContent=null, objectType=guider, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78825578414, createdName=ms2000000690830510, createdTime=Thu Aug 19 17:00:01 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=972873, encodeId=2bc69e287320, content=好东西！, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=38901548105, createdName=guanjian06, createdTime=Fri Jun 11 15:36:27 CST 2021, time=2021-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958898, encodeId=496d9588988e, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=67, replyNumber=1, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=03225481495, createdName=ms2000000317419565, createdTime=Tue Apr 20 22:05:36 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=957999, encodeId=459495e999a8, content=学, beContent=null, objectType=guider, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b545481506, createdName=ms1000000634463445, createdTime=Sun Apr 18 11:53:16 CST 2021, time=2021-04-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=957877, encodeId=103395e877fc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b545481506, createdName=ms1000000634463445, createdTime=Sat Apr 17 18:19:32 CST 2021, time=2021-04-17, status=1, ipAttribution=)]
    2021-06-11 guanjian06

    好东西！

    0

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    2021-04-20 ms2000000317419565

    学习了

    1

    展开1条回复
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    2021-04-18 ms1000000634463445

    学

    0

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    2021-04-17 ms1000000634463445

    学习

    0