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CFDA半夜发文:临床试验机构拟改为备案制 鼓励社会资本投资

2017-05-12 佚名 CFDA

此次征求意见稿若通过,临床试验机构中将有更多社会资本的参与空间,有利于提高临床试验人员的积极性、临床试验的效率等。


为进一步深化审评审批制度改革,促进药品医疗器械产业结构调整和技术创新,提高产业竞争力,满足公众临床需要,国家食品药品监督管理总局商国务院有关部门起草了《关于鼓励药品医疗器械创新改革临床试验管理的相关政策》(征求意见稿),现向社会公开征求意见。建议将修改意见于2017年5月25日前通过电子邮件反馈至国家食品药品监督管理总局(药品化妆品注册管理司)。征求意见截止时间为2017年6月10日。

征求意见稿中涉及法律法规修订的内容按相关程序进行。

电子邮件:yhzcszhc@cfda.gov.cn

特此公告。

附件:关于鼓励药品医疗器械创新改革临床试验管理的相关政策(征求意见稿)

食品药品监管总局

2017年5月11日

附件

关于鼓励药品医疗器械创新改革临床试验管理的相关政策(征求意见稿)

一、临床试验机构资格认定改为备案管理。取消临床试验机构的资格认定。具备临床试验条件的医疗机构在食品药品监管部门指定网站登记备案后,均可接受申请人委托开展临床试验。鼓励社会资本投资设立临床试验机构,提供临床试验专业服务。临床试验主要研究者须具有高级职称,参加过3个以上临床试验。临床试验申请人可聘请第三方对临床试验机构是否具备条件进行评估认证。临床试验机构实施备案管理后,食品药品监管部门要加强对临床试验项目进行现场检查,检查结果向社会公开。未能通过检查的临床试验项目,相关数据将不被食品药品监管部门接受。临床试验机构管理规定由食品药品监管部门会同卫生计生部门制定。

二、支持研究者和临床试验机构开展临床试验。支持医疗机构、医学研究机构、医药高等院校参与临床试验,将临床试验的条件与能力纳入医疗机构等级评审、临床重点学科认定的重要指标。鼓励三级甲等医疗机构、省属及以上高等本科医学院校的附属医院承接临床试验工作。对开展药物临床试验的医疗机构建立单独评价考核体系,仅用于开展临床试验的病床不计入医疗机构总病床,不规定病床效益、周转率、使用率等考评指标鼓励医疗机构设立专职临床试验部门,配备职业化的临床试验人员。鼓励临床医生参与药品医疗器械技术创新活动。允许境外企业和科研机构在中国开展药物Ⅰ期临床试验。开展临床试验的医务人员在职务提升、职称晋升等方面与临床医生一视同仁。结合完善单位绩效工资分配激励机制,保障临床试验研究者收入水平。

三、完善伦理委员会机制。临床试验需符合伦理道德标准,保证受试者在自愿参与之前被告知足够的试验信息,理解并签署《知情同意书》,确保受试者的安全、健康和权益受到保护。开展临床试验的医疗机构要成立伦理委员会,负责审查临床试验方案并作出批准、要求修改或不批准的决定,负责对临床试验进行定期审查和实时监督并接受监管部门的检查,负责本机构研究者资质的审核和监督。各地区可根据需要设立区域性伦理委员会,负责审查、监督医疗机构承担的临床试验项目和监督研究者的资质,负责审理研究者和申请人的上诉,负责区域内医疗机构伦理委员会的工作指导。卫生计生部门、中医药管理部门和食品药品监管部门要加强对伦理委员会工作的管理指导和业务监督。

四、提高伦理审查效率。申请人在向审评机构提出临床试验申请前,应先将临床试验方案交由伦理委员会审查批准。在中国境内开展多中心临床试验的,经组长单位伦理审查后,其他成员单位伦理委员会可认可组长单位的审查结论,不再重复审查。国家医学临床研究中心及获得国家科技重大专项和国家重点研发计划支持的临床试验机构,应整合资源建立统一的伦理审查平台,逐步推进伦理审查互认。

五、优化临床试验审查程序。建立和完善申请人与审评机构的沟通交流机制。开展Ⅰ期和Ⅲ期药物临床试验前,须经申请人与审评机构会议沟通后正式申请和受理。开展需审批的医疗器械临床试验前,须经申请人与审评机构会议沟通后正式申请和受理。审评机构自受理之日起60个工作日后,没有给出否定或质疑的审查意见即视为同意,申请人可按照递交的方案开展临床试验。临床试验期间,发生临床试验方案变更、重大药学变更或非临床研究安全性问题的,申请人应及时将变更情况报送审评机构。发现存在安全性及其他风险的,申请人应及时修改临床试验方案、暂停或终止临床试验。审评机构要加强对临床试验全过程的审查、监督,组织对正在开展的临床试验进行现场核查,审评过程中可以组织对临床试验数据进行有因检查。

六、接受境外临床试验数据。申请人在境外取得的临床试验数据,符合中国药品医疗器械注册相关要求的,经现场检查后可用于在中国申报注册申请。境外企业在中国进行的国际多中心药物临床试验,符合中国药品注册相关要求的,完成国际多中心临床试验后可以直接提出上市申请。在中国首次申请上市的药品医疗器械,申请人应提供不存在种族差异的临床试验数据。申请人在欧洲药品管理局、美国和日本获准上市仿制药的生物等效性试验数据,符合中国药品注册相关要求的,经现场检查后可用于在中国申报仿制药注册。申请人在境外获准上市的医疗器械,除需进行临床试验审批的第三类医疗器械外,在境外获准上市时提交的临床试验数据,可作为临床试验资料用于在中国申报医疗器械注册。

七、支持拓展性临床试验。对于正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段疾病的药物医疗器械,经临床试验初步观察可能获益,且符合伦理要求的,经知情同意后可用于其他患者,其安全性数据可用于支持审评审批。拓展使用的试验药物,仅限在开展Ⅱ、Ⅲ期临床试验的机构使用,使用人数不得超过临床试验规定的受试者数量。

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    2017-09-17 drj2014
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    2017-08-17 184****9840

    学习了受益匪浅

    0

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    2017-10-08 kord1993
  4. [GetPortalCommentsPageByObjectIdResponse(id=1718305, encodeId=fda41e18305cc, content=<a href='/topic/show?id=34cf424e727' target=_blank style='color:#2F92EE;'>#备案制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42477, encryptionId=34cf424e727, topicName=备案制)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b25e32549752, createdName=drj2014, createdTime=Sun Sep 17 11:49:00 CST 2017, time=2017-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234451, encodeId=7f84234451a7, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=144, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Thu Aug 17 13:32:50 CST 2017, time=2017-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1719277, encodeId=9a6f1e1927784, content=<a href='/topic/show?id=12b792553da' target=_blank style='color:#2F92EE;'>#资本#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92553, encryptionId=12b792553da, topicName=资本)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef5032698226, createdName=kord1993, createdTime=Sun Oct 08 13:49:00 CST 2017, time=2017-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890627, encodeId=00de189062e1f, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Sun Jan 28 21:49:00 CST 2018, time=2018-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642344, encodeId=e0d4164234468, content=<a href='/topic/show?id=c56ae4020fb' target=_blank style='color:#2F92EE;'>#社会资本#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74020, encryptionId=c56ae4020fb, topicName=社会资本)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=afa722912070, createdName=ms7524819409032184, createdTime=Sun Nov 19 23:49:00 CST 2017, time=2017-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590902, encodeId=9b571590902b8, content=<a href='/topic/show?id=f175424e6fe' target=_blank style='color:#2F92EE;'>#备案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42476, encryptionId=f175424e6fe, topicName=备案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=41f217885803, createdName=cenghis, createdTime=Sun May 14 01:49:00 CST 2017, time=2017-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1616690, encodeId=a2c01616690b0, content=<a href='/topic/show?id=e660e3936c0' target=_blank style='color:#2F92EE;'>#社会#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73936, encryptionId=e660e3936c0, topicName=社会)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e6de19781024, createdName=ms705947299214030, createdTime=Sun May 14 01:49:00 CST 2017, time=2017-05-14, status=1, ipAttribution=)]
    2018-01-28 stfoxst
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  6. [GetPortalCommentsPageByObjectIdResponse(id=1718305, encodeId=fda41e18305cc, content=<a href='/topic/show?id=34cf424e727' target=_blank style='color:#2F92EE;'>#备案制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42477, encryptionId=34cf424e727, topicName=备案制)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b25e32549752, createdName=drj2014, createdTime=Sun Sep 17 11:49:00 CST 2017, time=2017-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234451, encodeId=7f84234451a7, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=144, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Thu Aug 17 13:32:50 CST 2017, time=2017-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1719277, encodeId=9a6f1e1927784, content=<a href='/topic/show?id=12b792553da' target=_blank style='color:#2F92EE;'>#资本#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92553, encryptionId=12b792553da, topicName=资本)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef5032698226, createdName=kord1993, createdTime=Sun Oct 08 13:49:00 CST 2017, time=2017-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890627, encodeId=00de189062e1f, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Sun Jan 28 21:49:00 CST 2018, time=2018-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642344, encodeId=e0d4164234468, content=<a href='/topic/show?id=c56ae4020fb' target=_blank style='color:#2F92EE;'>#社会资本#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74020, encryptionId=c56ae4020fb, topicName=社会资本)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=afa722912070, createdName=ms7524819409032184, createdTime=Sun Nov 19 23:49:00 CST 2017, time=2017-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590902, encodeId=9b571590902b8, content=<a href='/topic/show?id=f175424e6fe' target=_blank style='color:#2F92EE;'>#备案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42476, encryptionId=f175424e6fe, topicName=备案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=41f217885803, createdName=cenghis, createdTime=Sun May 14 01:49:00 CST 2017, time=2017-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1616690, encodeId=a2c01616690b0, content=<a href='/topic/show?id=e660e3936c0' target=_blank style='color:#2F92EE;'>#社会#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73936, encryptionId=e660e3936c0, topicName=社会)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e6de19781024, createdName=ms705947299214030, createdTime=Sun May 14 01:49:00 CST 2017, time=2017-05-14, status=1, ipAttribution=)]
    2017-05-14 cenghis
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