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关于对ICH E6（R2）《药物临床试验管理规范》修订工作开展问卷调查的通知

2020-05-19 CDE CDE

药物临床试验管理规范
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2016年11月，ICH发布了《对E6(R1)的综合附录：药物床试验质量管理规范E6(R2)》(以下简称E6(R2))。但自E6(R2)制定以来，临床试验继续在试验设计和技术创新方面不断发展。2019

2016年11月，ICH发布了《对E6(R1)的综合附录：药物床试验质量管理规范E6(R2)》(以下简称E6(R2))。但自E6(R2)制定以来，临床试验继续在试验设计和技术创新方面不断发展。2019年6月，ICH大会批准新议题：《E6(R3)：药物临床试验质量管理规范（GCP）》。同年11月，《E6(R3)概念文件》和《业务计划》获得ICH管理委员会批准，E6(R3)专家工作组（以下简称EWG）同时成立，启动对ICH GCP的全面修订。

《E6(R3)概念文件》指出，计划通过此次修订，将GCP的原则应用于日益多样化的临床试验类型以及支持药品监管和相关医疗决策的数据中，并在任何适当的情况下促进临床试验的技术创新。E6(R3)最终将由总体原则、目标文件、附件1（干预性临床试验）和附件2（非传统干预性临床试验的附加考虑）构成。总体原则、目标文件以及附件1将取代现行版E6(R2)。EWG在此次修订过程中，希望加强多方面的参与，广泛听取意见。

根据ICH工作安排，以E6(R3)EWG提供的“临床试验转型倡议组织(CTTI)”2019年在“告知ICH E6革新”调查中使用的问卷为基础，国家药品监督管理局药品审评中心组织编写了《调查问卷：ICH E6(R2)<药物临床试验质量管理规范>全面修订》及《问卷填写说明》。以收集国内各方对E6(R2)各个条目修订的必要性和修改建议。此外，为方便阅读，翻译形成了《E6(R3)概念文件》中文版初稿。

我们诚挚地欢迎社会各界，积极填写此问卷，并及时反馈给我们，支持此次E6(R3) EWG对E6(R2)的全面修订。问卷调查的时限为自发布之日起一个月。

请您将填写完成的问卷邮件发送至：gkzhqyj@cde.org.cn，并在邮件标题注明【E6(R2)调查问卷反馈】，任何问题也请联系此邮箱。

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
                                                                                                                                         2020年5月15日

附件 1 ： 调查问卷：ICH E6《药物临床试验质量管理规范》全面修订.xls
附件 2 ： 问卷填写说明：ICH E6(R2)《药物临床试验质量管理规范》全面修订调查问卷.docx
附件 3 ： 概念文件终版（英文版）ICH E6(R3) 药物临床试验质量管理规范.pdf
附件 4 ： 概念文件终版（中文版初稿）ICH E6(R3) 药物临床试验质量管理规范.docx

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1978235, encodeId=027119e8235a4, content=<a href='/topic/show?id=1111e60615a' target=_blank style='color:#2F92EE;'>#管理规范#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76061, encryptionId=1111e60615a, topicName=管理规范)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Thu Oct 01 17:58:04 CST 2020, time=2020-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1941844, encodeId=cb16194184481, content=<a href='/topic/show?id=902e8e652e4' target=_blank style='color:#2F92EE;'>#药物临床试验管理规范#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87652, encryptionId=902e8e652e4, topicName=药物临床试验管理规范)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Tue Jan 12 07:58:04 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881656, encodeId=6efe88165606, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Tue Sep 01 08:11:06 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055317, encodeId=7909205531e1f, content=<a href='/topic/show?id=72c69e2076e' target=_blank style='color:#2F92EE;'>#问卷调查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97207, encryptionId=72c69e2076e, topicName=问卷调查)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/101173734/363C99735735B7F4CB11D5F78F580525/100, createdBy=aab22500211, createdName=ms3025846204744509, createdTime=Thu Sep 17 14:58:04 CST 2020, time=2020-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1316379, encodeId=9e6b13163e945, content=<a href='/topic/show?id=f3789349c3' target=_blank style='color:#2F92EE;'>#ICH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9349, encryptionId=f3789349c3, topicName=ICH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Thu May 21 03:58:04 CST 2020, time=2020-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1480938, encodeId=9a1b14809386f, content=<a href='/topic/show?id=96a08e64833' target=_blank style='color:#2F92EE;'>#药物临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87648, encryptionId=96a08e64833, topicName=药物临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu May 21 03:58:04 CST 2020, time=2020-05-21, status=1, ipAttribution=)]
    2020-10-01 luoxiaog

    #管理规范#

    0

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    2021-01-12 psybestwish

    #药物临床试验管理规范#

    0

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    2020-09-01 14818eb4m67暂无昵称

    学习

    0

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    2020-09-17 ms3025846204744509

    #问卷调查#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1978235, encodeId=027119e8235a4, content=<a href='/topic/show?id=1111e60615a' target=_blank style='color:#2F92EE;'>#管理规范#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76061, encryptionId=1111e60615a, topicName=管理规范)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Thu Oct 01 17:58:04 CST 2020, time=2020-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1941844, encodeId=cb16194184481, content=<a href='/topic/show?id=902e8e652e4' target=_blank style='color:#2F92EE;'>#药物临床试验管理规范#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87652, encryptionId=902e8e652e4, topicName=药物临床试验管理规范)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Tue Jan 12 07:58:04 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881656, encodeId=6efe88165606, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Tue Sep 01 08:11:06 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055317, encodeId=7909205531e1f, content=<a href='/topic/show?id=72c69e2076e' target=_blank style='color:#2F92EE;'>#问卷调查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97207, encryptionId=72c69e2076e, topicName=问卷调查)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/101173734/363C99735735B7F4CB11D5F78F580525/100, createdBy=aab22500211, createdName=ms3025846204744509, createdTime=Thu Sep 17 14:58:04 CST 2020, time=2020-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1316379, encodeId=9e6b13163e945, content=<a href='/topic/show?id=f3789349c3' target=_blank style='color:#2F92EE;'>#ICH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9349, encryptionId=f3789349c3, topicName=ICH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Thu May 21 03:58:04 CST 2020, time=2020-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1480938, encodeId=9a1b14809386f, content=<a href='/topic/show?id=96a08e64833' target=_blank style='color:#2F92EE;'>#药物临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87648, encryptionId=96a08e64833, topicName=药物临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu May 21 03:58:04 CST 2020, time=2020-05-21, status=1, ipAttribution=)]
    2020-05-21 diushouji

    #ICH#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1978235, encodeId=027119e8235a4, content=<a href='/topic/show?id=1111e60615a' target=_blank style='color:#2F92EE;'>#管理规范#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76061, encryptionId=1111e60615a, topicName=管理规范)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Thu Oct 01 17:58:04 CST 2020, time=2020-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1941844, encodeId=cb16194184481, content=<a href='/topic/show?id=902e8e652e4' target=_blank style='color:#2F92EE;'>#药物临床试验管理规范#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87652, encryptionId=902e8e652e4, topicName=药物临床试验管理规范)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Tue Jan 12 07:58:04 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881656, encodeId=6efe88165606, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Tue Sep 01 08:11:06 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055317, encodeId=7909205531e1f, content=<a href='/topic/show?id=72c69e2076e' target=_blank style='color:#2F92EE;'>#问卷调查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97207, encryptionId=72c69e2076e, topicName=问卷调查)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/101173734/363C99735735B7F4CB11D5F78F580525/100, createdBy=aab22500211, createdName=ms3025846204744509, createdTime=Thu Sep 17 14:58:04 CST 2020, time=2020-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1316379, encodeId=9e6b13163e945, content=<a href='/topic/show?id=f3789349c3' target=_blank style='color:#2F92EE;'>#ICH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9349, encryptionId=f3789349c3, topicName=ICH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Thu May 21 03:58:04 CST 2020, time=2020-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1480938, encodeId=9a1b14809386f, content=<a href='/topic/show?id=96a08e64833' target=_blank style='color:#2F92EE;'>#药物临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87648, encryptionId=96a08e64833, topicName=药物临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu May 21 03:58:04 CST 2020, time=2020-05-21, status=1, ipAttribution=)]
    2020-05-21 hb2008ye

    #药物临床试验#

    0