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国家药监局:新药上市许可行政审批时限压缩1/3

2018-11-22 董童 人民网-人民健康网

日前,国家药品监督管理局在官网发布《关于贯彻落实国务院“证照分离”改革要求做好药品监管相关审批工作的通知》(以下简称《通知》),要求加快新药上市许可,进一步将新药上市许可的法定行政审批时限压缩三分之一。

日前,国家药品监督管理局在官网发布《关于贯彻落实国务院“证照分离”改革要求做好药品监管相关审批工作的通知》(以下简称《通知》),要求加快新药上市许可,进一步将新药上市许可的法定行政审批时限压缩三分之一。

通知提出,要简化流程,优化审批服务。一是结合行政区域实际,整合药品行政审批业务办理窗口,力争实行集中统一受理,并在门户网站、受理场所公示相关流程和时限要求。二是各级药品监管部门在保证审批质量前提下,进一步简化审批步骤。各省药品监管部门要将开办药品生产、经营企业等审批事项的行政审批时限压缩三分之一。借助“证照分离”改革和“优化营商环境”的政策契机,按照党中央国务院有关药品审评审批制度改革的部署和《中华人民共和国行政许可法》的要求,加快新药上市许可,进一步将新药上市许可的法定行政审批时限压缩三分之一。三是要在药品再注册和互联网药品信息服务审批中进一步推广网上业务办理,公示审批程序、受理条件和办理标准,公开办理进度,除涉及药品质量安全必须进行现场检查的外,不再另行开展药品再注册、互联网药品信息服务等审批事项现场检查。四是试行告知承诺。对医疗机构放射性药品使用许可(一、二类)等审批事项试行告知承诺。

通知明确,各地要依法依规、合理设置审批条件和标准,对审批标准进行公平性审查。对于涉及药品质量安全的审批事项务必严格把关,注意防止出现简化流程、提升服务后降低审批标准现象。要明确“谁审批谁监管”原则,加强对药品生产、经营和使用环节全过程的监督检查。要进一步强化风险和隐患的排查,突出对重点企业和重点品种的现场检查、产品抽检,多措并举提升监管成效。要做到放开准入和严格监管相结合,督促从业者持续合法合规,守住药品质量安全的底线。

通知还提出,各地要加强部门协作,实现证照信息在线获取、信息共享。各地要建立信用管理制度,发挥社会引导和舆论监督作用,将弄虚作假、违背承诺或严重违法违规的申请人,纳入信用“黑名单”,予以联合惩戒。

通知最后强调,各口岸药监局和口岸药检所在配合海关总署推进国际贸易“单一窗口”建设过程中,要认真落实海关总署、国家药品监督管理局2018年第148号公告要求和 “证照分离”改革要求,充分利用当地资源,在药品和中药材进口备案过程中通过在线获取核验有关证明文件等措施优化工作程序。同时做好审批程序、受理条件、办理标准、办理进度等信息公开,并推进部门间信息共享应用,加强事中事后监管。

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1676917, encodeId=d29416e69171c, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Sat Apr 27 07:02:00 CST 2019, time=2019-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1694096, encodeId=844616940964d, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Tue Sep 17 05:02:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301623, encodeId=94341301623e6, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429180, encodeId=b21514291806e, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353344, encodeId=491d3533448c, content=好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30251637888, createdName=lietome15, createdTime=Thu Nov 22 11:25:00 CST 2018, time=2018-11-22, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1676917, encodeId=d29416e69171c, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Sat Apr 27 07:02:00 CST 2019, time=2019-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1694096, encodeId=844616940964d, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Tue Sep 17 05:02:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301623, encodeId=94341301623e6, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429180, encodeId=b21514291806e, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353344, encodeId=491d3533448c, content=好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30251637888, createdName=lietome15, createdTime=Thu Nov 22 11:25:00 CST 2018, time=2018-11-22, status=1, ipAttribution=)]
    2018-11-24 xuyu
  4. [GetPortalCommentsPageByObjectIdResponse(id=1676917, encodeId=d29416e69171c, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Sat Apr 27 07:02:00 CST 2019, time=2019-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1694096, encodeId=844616940964d, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Tue Sep 17 05:02:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301623, encodeId=94341301623e6, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429180, encodeId=b21514291806e, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353344, encodeId=491d3533448c, content=好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30251637888, createdName=lietome15, createdTime=Thu Nov 22 11:25:00 CST 2018, time=2018-11-22, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1676917, encodeId=d29416e69171c, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Sat Apr 27 07:02:00 CST 2019, time=2019-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1694096, encodeId=844616940964d, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Tue Sep 17 05:02:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301623, encodeId=94341301623e6, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429180, encodeId=b21514291806e, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sat Nov 24 02:02:00 CST 2018, time=2018-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353344, encodeId=491d3533448c, content=好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30251637888, createdName=lietome15, createdTime=Thu Nov 22 11:25:00 CST 2018, time=2018-11-22, status=1, ipAttribution=)]
    2018-11-22 lietome15

    好文,值得点赞!认真学习了,把经验应用于实践,为患者解除病痛。

    0

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