药物临床试验伦理审查工作指导原则

国家药品监督管理局药品审评中心(CDE) CDE

为加强药物临床试验质量管理和受试者保护,规范和指导伦理委员会的药物临床试验伦理审查工作,提高药物临床试验伦理审查工作质量,根据《药品注册管理办法》和《药物临床试验质量管理规范》的有关规定,国家食品药品

中文标题:

药物临床试验伦理审查工作指导原则

发布日期:

简要介绍:

为加强药物临床试验质量管理和受试者保护,规范和指导伦理委员会的药物临床试验伦理审查工作,提高药物临床试验伦理审查工作质量,根据《药品注册管理办法》和《药物临床试验质量管理规范》的有关规定,国家食品药品监督管理局组织制定了《药物临床试验伦理审查工作指导原则》,并于日前印发。该《指导原则》共五十二条,自发布之日起施行。

关于印发药物临床试验伦理审查工作指导原则的通知
国食药监注[2010]436号

各省、自治区、直辖市食品药品监督管理局(药品监督管理局),总后卫生部药品监督管理局:

    为加强药物临床试验的质量管理和受试者的保护,规范和指导伦理委员会的药物临床试验伦理审查工作,提高药物临床试验伦理审查工作质量,根据《药品注册管理办法》和《药物临床试验质量管理规范》的有关规定,国家局组织制定了《药物临床试验伦理审查工作指导原则》,现予印发。请你局指导本辖区内药物临床试验机构学习,参照执行。

国家食品药品监督管理局
二○一○年十一月二日

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    2021-01-25 LeoQ

    新形势下的学习

    0

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    2020-08-13 彭红

    新形式下的浪潮

    0

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    2020-08-10 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=919707, encodeId=97cc919e074a, content=新形势下的学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201030/d4f9cda9838b4ced8e47258b7d2fa483/822ba90b8644401f8d14936df38a1720.jpg, createdBy=b0475413073, createdName=LeoQ, createdTime=Mon Jan 25 14:55:13 CST 2021, time=2021-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=808513, encodeId=558a80851335, content=新形式下的浪潮, beContent=null, objectType=guider, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200726/689f5dfb6e5b4165b1a5156604f91964/518e32492fdf40689b7cc8c73fa0f600.jpg, createdBy=cc9a5402881, createdName=彭红, createdTime=Thu Aug 13 19:22:49 CST 2020, time=2020-08-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807337, encodeId=f03b80e3372e, content=学习了,谢谢分享, beContent=null, objectType=guider, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Aug 10 21:34:35 CST 2020, time=2020-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807179, encodeId=84f580e1792f, content=这都2020了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e6785205858, createdName=1474c43fm46暂无昵称, createdTime=Mon Aug 10 06:59:32 CST 2020, time=2020-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807123, encodeId=0e6b80e123ff, content=好的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b7a75409810, createdName=ms3000000694882001, createdTime=Sun Aug 09 17:36:06 CST 2020, time=2020-08-09, status=1, ipAttribution=)]
    2020-08-10 1474c43fm46暂无昵称

    这都2020了

    0

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    2020-08-09 ms3000000694882001

    好的资料

    0