《免于进行临床试验的体外诊断试剂临床评价资料基本要求(试行)》解读

2017-11-09 医药界 CFDA

国家食品药品监督管理总局组织制定并于2017年11月3日发布了《免于进行临床试验的体外诊断试剂临床评价资料基本要求(试行)》,自发布之日起施行。

为贯彻落实中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42),深入推进“放管服”改革工作,推进基于风险的产品评价方式,优化配置临床试验和审评审批资源,促进安全有效、风险可控的产品尽快上市,国家食品药品监督管理总局组织制定并于2017年11月3日发布了《免于进行临床试验的体外诊断试剂临床评价资料基本要求(试行)》,自发布之日起施行。

一、背景情况

根据体外诊断试剂产品的特点,2014年发布的《体外诊断试剂注册管理办法》(国家食品药品监督管理总局令第5号)第二十九条明确规定,无需进行临床试验的体外诊断试剂,申请人或者备案人应当通过对涵盖预期用途及干扰因素的临床样本的评估、综合文献资料等非临床试验的方式对体外诊断试剂的临床性能进行评价。因此,总局发布了免于进行临床试验的体外诊断试剂临床评价的基本要求, 配合《免于进行临床试验的体外诊断试剂目录》使用,用于指导注册申请人进行体外诊断试剂临床评价工作。

2017年年初启动制定工作,2017年5月征求意见,经综合各方面建议并参考国内外相关文献资料,反复修改完善后予以制定,于2017年11月3日发布实施。

二、主要内容

内容包括适用范围、基本要求、临床评价途径、试验方法、临床评价报告、其他评价资料共六章,描述了临床评价试验的基本要求及申报资料的相关要求。主要内容有:

(一)突出了申请人主体责任。明确了申请人自行或委托其他机构或实验室在中国境内完成临床评价工作,试验过程由申请人进行管理,评价报告应由申请人/代理人签章,试验数据的真实性由申请人负责。

(二)强调了样本来源追溯性的要求。要求评价用样本(病例)原始资料中应至少包括样本来源、唯一且可追溯的编号、年龄、性别、样本类型、样本临床背景信息等内容。

(三)明确了临床评价的试验方法。可参考相关方法学比对的指导原则开展试验,并根据产品特点选择合适的统计学方法进行统计分析,以求得到客观可信的结果。为贯彻落实中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42),深入推进“放管服”改革工作,推进基于风险的产品评价方式,优化配置临床试验和审评审批资源,促进安全有效、风险可控的产品尽快上市,国家食品药品监督管理总局组织制定并于2017年11月3日发布了《免于进行临床试验的体外诊断试剂临床评价资料基本要求(试行)》,自发布之日起施行。


版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1966835, encodeId=73001966835a2, content=<a href='/topic/show?id=e09323013fd' target=_blank style='color:#2F92EE;'>#临床评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23013, encryptionId=e09323013fd, topicName=临床评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cfa576, createdName=wfang545, createdTime=Thu Nov 09 18:42:00 CST 2017, time=2017-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006642, encodeId=c802200664262, content=<a href='/topic/show?id=4ae54210912' target=_blank style='color:#2F92EE;'>#基本要求#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42109, encryptionId=4ae54210912, topicName=基本要求)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Sep 11 21:42:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1320692, encodeId=daa6132069292, content=<a href='/topic/show?id=9ab3265e951' target=_blank style='color:#2F92EE;'>#体外诊断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26579, encryptionId=9ab3265e951, topicName=体外诊断)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6732482, createdName=w984445tii, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444289, encodeId=66911444289b5, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=260013, encodeId=fca92600131d, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Nov 09 15:24:13 CST 2017, time=2017-11-09, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1966835, encodeId=73001966835a2, content=<a href='/topic/show?id=e09323013fd' target=_blank style='color:#2F92EE;'>#临床评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23013, encryptionId=e09323013fd, topicName=临床评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cfa576, createdName=wfang545, createdTime=Thu Nov 09 18:42:00 CST 2017, time=2017-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006642, encodeId=c802200664262, content=<a href='/topic/show?id=4ae54210912' target=_blank style='color:#2F92EE;'>#基本要求#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42109, encryptionId=4ae54210912, topicName=基本要求)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Sep 11 21:42:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1320692, encodeId=daa6132069292, content=<a href='/topic/show?id=9ab3265e951' target=_blank style='color:#2F92EE;'>#体外诊断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26579, encryptionId=9ab3265e951, topicName=体外诊断)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6732482, createdName=w984445tii, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444289, encodeId=66911444289b5, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=260013, encodeId=fca92600131d, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Nov 09 15:24:13 CST 2017, time=2017-11-09, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1966835, encodeId=73001966835a2, content=<a href='/topic/show?id=e09323013fd' target=_blank style='color:#2F92EE;'>#临床评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23013, encryptionId=e09323013fd, topicName=临床评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cfa576, createdName=wfang545, createdTime=Thu Nov 09 18:42:00 CST 2017, time=2017-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006642, encodeId=c802200664262, content=<a href='/topic/show?id=4ae54210912' target=_blank style='color:#2F92EE;'>#基本要求#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42109, encryptionId=4ae54210912, topicName=基本要求)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Sep 11 21:42:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1320692, encodeId=daa6132069292, content=<a href='/topic/show?id=9ab3265e951' target=_blank style='color:#2F92EE;'>#体外诊断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26579, encryptionId=9ab3265e951, topicName=体外诊断)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6732482, createdName=w984445tii, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444289, encodeId=66911444289b5, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=260013, encodeId=fca92600131d, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Nov 09 15:24:13 CST 2017, time=2017-11-09, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1966835, encodeId=73001966835a2, content=<a href='/topic/show?id=e09323013fd' target=_blank style='color:#2F92EE;'>#临床评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23013, encryptionId=e09323013fd, topicName=临床评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cfa576, createdName=wfang545, createdTime=Thu Nov 09 18:42:00 CST 2017, time=2017-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006642, encodeId=c802200664262, content=<a href='/topic/show?id=4ae54210912' target=_blank style='color:#2F92EE;'>#基本要求#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42109, encryptionId=4ae54210912, topicName=基本要求)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Sep 11 21:42:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1320692, encodeId=daa6132069292, content=<a href='/topic/show?id=9ab3265e951' target=_blank style='color:#2F92EE;'>#体外诊断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26579, encryptionId=9ab3265e951, topicName=体外诊断)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6732482, createdName=w984445tii, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444289, encodeId=66911444289b5, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=260013, encodeId=fca92600131d, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Nov 09 15:24:13 CST 2017, time=2017-11-09, status=1, ipAttribution=)]
    2017-11-11 huagfeg
  5. [GetPortalCommentsPageByObjectIdResponse(id=1966835, encodeId=73001966835a2, content=<a href='/topic/show?id=e09323013fd' target=_blank style='color:#2F92EE;'>#临床评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23013, encryptionId=e09323013fd, topicName=临床评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cfa576, createdName=wfang545, createdTime=Thu Nov 09 18:42:00 CST 2017, time=2017-11-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006642, encodeId=c802200664262, content=<a href='/topic/show?id=4ae54210912' target=_blank style='color:#2F92EE;'>#基本要求#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42109, encryptionId=4ae54210912, topicName=基本要求)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Tue Sep 11 21:42:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1320692, encodeId=daa6132069292, content=<a href='/topic/show?id=9ab3265e951' target=_blank style='color:#2F92EE;'>#体外诊断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26579, encryptionId=9ab3265e951, topicName=体外诊断)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6732482, createdName=w984445tii, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444289, encodeId=66911444289b5, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Nov 11 05:42:00 CST 2017, time=2017-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=260013, encodeId=fca92600131d, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Nov 09 15:24:13 CST 2017, time=2017-11-09, status=1, ipAttribution=)]
    2017-11-09 Y—xianghai

    学习了新知识

    0

相关资讯

CFDA:总局办公厅关于开展生化药品专项检查的通知

《药品生产质量管理规范生化药品附录》(以下简称《附录》)已于2017年3月13日公布,并于2017年9月1日施行。为进一步规范生化药品生产,严厉打击违法违规行为,确保生化药品《附录》贯彻实施到位,总局要求各省对生化药品进行专项检查,现将有关事项通知如下

备案制细则来了!CFDA发布《药物临床试验机构管理规定(征求意见稿)》

10月26日,为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》,做好药物临床试验机构资格认定调整为备案管理的相关准备工作,CFDA官网发布了公开征求《药物临床试验机构管理规定(征求意见稿)》意见。

药械交易监管要线上线下一致

11月2日,国家食品药品监管总局发布《关于加强互联网药品医疗器械交易监管工作的通知》,明确建立完善互联网药品、医疗器械交易服务企业(第三方)监管制度,按照“线上线下一致”原则,规范互联网药品、医疗器械交易行为。

跨国药企出新招 本土创新药玩家迎洗牌

随着创新药将从“中国新”逐步变为“全球新”,外资品种的加速引入,国内简单“me-too”甚至“me-worse”的药品将面临严重冲击。

CFDA:中药注射剂安全性再评价方案已初步形成

国家食品药品监督管理总局9日举行新闻发布会,介绍药品医疗器械审评审批改革鼓励创新工作有关情况。

CFDA发文:加强互联网药品医疗器械交易监管

11月2日,食品药品监管总局办公厅发布公告称,为贯彻落实《国务院关于取消一批行政许可事项的决定》(国发〔2017〕46号)的要求,做好相关事中事后监管措施的衔接工作,就加强互联网药品、医疗器械交易监管工作有关事项通知如下: