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2017年CFDA重点工作:建立中国药品橙皮书、释放临床试验资源

2017-03-23 佚名 医药魔方数据

2017年3月23日,全国药品注册管理工作会在京召开,会议研究进一步全面贯彻落实《国务院关于药品医疗器械审评审批制度改革的意见》和全国食品药品监督管理暨党风廉政建设工作会议精神,总结过去一年的药品注册工作,研究部署2017年药品注册管理重点任务,进一步深入推进药品审评审批制度改革。总局党组成员、副局长吴浈同志出席会议并讲话,各省、市、自治区、直辖市食品药品监管部门分管药品注册工作的负责同志和总局各


2017年3月23日,全国药品注册管理工作会在京召开,会议研究进一步全面贯彻落实《国务院关于药品医疗器械审评审批制度改革的意见》和全国食品药品监督管理暨党风廉政建设工作会议精神,总结过去一年的药品注册工作,研究部署2017年药品注册管理重点任务,进一步深入推进药品审评审批制度改革。总局党组成员、副局长吴浈同志出席会议并讲话,各省、市、自治区、直辖市食品药品监管部门分管药品注册工作的负责同志和总局各司局、直属事业单位的有关负责同志参加了会议。

2016年药品审评审批制度改革成绩显著,一是药品注册审评效率明显提高,基本消除了注册积压。二是品种申报结构明显优化,以化学药品为例,2016年接受的化学创新药申请240件,较2015年增长了18%,与2015年相比,仿制药申请减少了92%。三是临床急需药品审评明显加快,公众对于药品审评审批制度改革的获得感大幅提升。其中13价肺炎球菌结合疫苗、贝那鲁肽注射液、富马酸替诺福韦二吡呋酯、富马酸贝达喹啉、苹果酸诺奈沙星、吉非替尼片、金花清感颗粒等一批应对严重公共卫生难题和重大疑难疾病的创新药和首仿药通过优先审评审批进入市场。四是药品临床试验质量进一步提高,新药研发生态环境进一步优化。

2017年的药品注册管理工作将继续按照国务院《关于改革药品医疗器械审评审批制度改革的意见》的要求,继续以提高药品质量为核心,以提高审评效率和水平为重点,以鼓励创新为导向大力推进药品审评审批制度改革工作,重点做好下几个方面的工作:

深化改革,进一步鼓励药品创新;

加快推进药品质量和疗效一致性评价工作;

开展生产工艺信息登记、建立药品品种档案;

改革受理模式,加快推进电子通用技术文档(eCTD)系统建设逐步实现化学仿制药的网上集中申报;

进一步优化药品审评审批流程,进一步提高审评审批效率和水平,适应当前医药行业创新需要;

参照发达国家做法建立我国的上市药品目录集(“橙皮书”),引导仿制药进一步提升水平;

加强临床试验机构管理,释放临床试验资源,更好的服务企业开展仿制药质量和疗效一致性评价;

进一步推动药品上市许可持有人制度试点。

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    2017-04-25 stfoxst
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    2017-03-25 飘飘爱

    很好

    0

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    2017-03-24 天涯183

    非常好的研究

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1945496, encodeId=9460194549619, content=<a href='/topic/show?id=f7cb9588e49' target=_blank style='color:#2F92EE;'>#重点工作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95887, encryptionId=f7cb9588e49, topicName=重点工作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Jan 20 03:30:00 CST 2018, time=2018-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890618, encodeId=7f581890618ab, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Tue Apr 25 04:30:00 CST 2017, time=2017-04-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182699, encodeId=792a182699ce, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2emBzjO0FtqTJ05AqrEEdRmp6tmlsLXqpzfxWdtgbbgPGWRHagoK9fLTd3IayRPgkJVIVBWtdlmnkBhOIR4cFM/0, createdBy=e8d51649330, createdName=飘飘爱, createdTime=Sat Mar 25 23:36:35 CST 2017, time=2017-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182398, encodeId=fa9e18239892, content=非常好的研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Fri Mar 24 12:22:08 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182358, encodeId=f5aa182358c7, content=好好学习,涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLANEL7Sww3HicKsN9aribicAmGGWXOIMEiaZ1iadgZg9RibjqSwIKUS8gSPib2NwTVg2zVvVJhdP3BkuDIl/0, createdBy=944d1605392, createdName=shaosai, createdTime=Fri Mar 24 08:17:08 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182350, encodeId=fab718235039, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Mar 24 07:57:06 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182310, encodeId=7539182310fd, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Mar 24 06:36:06 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182281, encodeId=25cd182281c8, content=继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Fri Mar 24 00:58:01 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182271, encodeId=22b11822e1cc, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Mar 24 00:03:52 CST 2017, time=2017-03-24, status=1, ipAttribution=)]
    2017-03-24 shaosai

    好好学习,涨知识

    0

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    2017-03-24 明月清辉

    谢谢分享,学习了

    0

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    2017-03-24 刘煜

    阅读了谢谢分享

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1945496, encodeId=9460194549619, content=<a href='/topic/show?id=f7cb9588e49' target=_blank style='color:#2F92EE;'>#重点工作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95887, encryptionId=f7cb9588e49, topicName=重点工作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Jan 20 03:30:00 CST 2018, time=2018-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890618, encodeId=7f581890618ab, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Tue Apr 25 04:30:00 CST 2017, time=2017-04-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182699, encodeId=792a182699ce, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2emBzjO0FtqTJ05AqrEEdRmp6tmlsLXqpzfxWdtgbbgPGWRHagoK9fLTd3IayRPgkJVIVBWtdlmnkBhOIR4cFM/0, createdBy=e8d51649330, createdName=飘飘爱, createdTime=Sat Mar 25 23:36:35 CST 2017, time=2017-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182398, encodeId=fa9e18239892, content=非常好的研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Fri Mar 24 12:22:08 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182358, encodeId=f5aa182358c7, content=好好学习,涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLANEL7Sww3HicKsN9aribicAmGGWXOIMEiaZ1iadgZg9RibjqSwIKUS8gSPib2NwTVg2zVvVJhdP3BkuDIl/0, createdBy=944d1605392, createdName=shaosai, createdTime=Fri Mar 24 08:17:08 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182350, encodeId=fab718235039, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Mar 24 07:57:06 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182310, encodeId=7539182310fd, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Mar 24 06:36:06 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182281, encodeId=25cd182281c8, content=继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Fri Mar 24 00:58:01 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182271, encodeId=22b11822e1cc, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Mar 24 00:03:52 CST 2017, time=2017-03-24, status=1, ipAttribution=)]
    2017-03-24 1dd8c52fm63(暂无匿称)

    继续关注

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1945496, encodeId=9460194549619, content=<a href='/topic/show?id=f7cb9588e49' target=_blank style='color:#2F92EE;'>#重点工作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95887, encryptionId=f7cb9588e49, topicName=重点工作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Jan 20 03:30:00 CST 2018, time=2018-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890618, encodeId=7f581890618ab, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Tue Apr 25 04:30:00 CST 2017, time=2017-04-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182699, encodeId=792a182699ce, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2emBzjO0FtqTJ05AqrEEdRmp6tmlsLXqpzfxWdtgbbgPGWRHagoK9fLTd3IayRPgkJVIVBWtdlmnkBhOIR4cFM/0, createdBy=e8d51649330, createdName=飘飘爱, createdTime=Sat Mar 25 23:36:35 CST 2017, time=2017-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182398, encodeId=fa9e18239892, content=非常好的研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Fri Mar 24 12:22:08 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182358, encodeId=f5aa182358c7, content=好好学习,涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLANEL7Sww3HicKsN9aribicAmGGWXOIMEiaZ1iadgZg9RibjqSwIKUS8gSPib2NwTVg2zVvVJhdP3BkuDIl/0, createdBy=944d1605392, createdName=shaosai, createdTime=Fri Mar 24 08:17:08 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182350, encodeId=fab718235039, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Mar 24 07:57:06 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182310, encodeId=7539182310fd, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Mar 24 06:36:06 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182281, encodeId=25cd182281c8, content=继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Fri Mar 24 00:58:01 CST 2017, time=2017-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=182271, encodeId=22b11822e1cc, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Mar 24 00:03:52 CST 2017, time=2017-03-24, status=1, ipAttribution=)]
    2017-03-24 飛歌

    学习了很有用

    0

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