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受管制审批延误 欧洲抗癌新药上市要等多年

2018-12-05 佚名 中国新闻网

据外媒报道,由于医学界对癌症的研究取得突破,许多新的癌症药物也被研发出来,但英国一项研究发现,由于管制和审批过程的延误,导致欧洲病人通常要等待多年,才能见到这些药物面世。当地时间4日,英国癌症研究院发表报告,称2000年至2016年,欧洲药品管理局批准了97种拥有177种用途的癌症药物。其中,2009年至2016年的每年平均批准速度为14.6种,比2000年至2008年的7.5种增加一倍。然而,药

据外媒报道,由于医学界对癌症的研究取得突破,许多新的癌症药物也被研发出来,但英国一项研究发现,由于管制和审批过程的延误,导致欧洲病人通常要等待多年,才能见到这些药物面世。

当地时间4日,英国癌症研究院发表报告,称2000年至2016年,欧洲药品管理局批准了97种拥有177种用途的癌症药物。其中,2009年至2016年的每年平均批准速度为14.6种,比2000年至2008年的7.5种增加一倍。

然而,药物从第一阶段临床试验到获得欧洲药品管理局营销执照,其平均时间,从2000年至2008年期间的7.8年,延长到2009年至2016年期间的9.1年。

而从获得专利权,到获得英国国民医疗保健系统批准使用在病人身上的时间,从2000年至2008年的12.7年,延长到2009年至2016年的14.1年。

领导该研究的英国癌症研究院院长沃克曼教授说:“科技的发展使过去10年研发出来的新药有所增加,但这项研究显示,我们要做得更多,才能把创新疗法带给病人。”

研究人员称,随着对癌症的了解取得显着进展,癌症药物的研发和制造应该变得更快,虽延误的部分原因是要批准靶向疗法,但其实只须根据较小规模的临床试验就行了。

沃克曼还表示,从药物研发、临床试验到管制与审批,问题的症结无法归咎于任何一个阶段,但“繁文缛节和官僚主义”使得整个过程被延误。

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    2018-12-09 清风拂面

    谢谢分享学习

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1651213, encodeId=55be16512131b, content=<a href='/topic/show?id=1e61555223e' target=_blank style='color:#2F92EE;'>#抗癌新药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55522, encryptionId=1e61555223e, topicName=抗癌新药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a6224143528, createdName=zhangmingxiang, createdTime=Sun Dec 23 17:23:00 CST 2018, time=2018-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676918, encodeId=8bf116e6918d6, 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=64, 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=Tue Mar 12 02:23:00 CST 2019, time=2019-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=354964, encodeId=73ad354964d4, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Dec 09 23:49:51 CST 2018, time=2018-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339149, encodeId=63441339149ed, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Fri Dec 07 14:23:00 CST 2018, time=2018-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=354605, encodeId=1d023546055c, content=了解一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Thu Dec 06 09:40:32 CST 2018, time=2018-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=354571, encodeId=9e6d3545e110, content=学习了,谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Wed Dec 05 23:39:11 CST 2018, time=2018-12-05, status=1, ipAttribution=)]
    2018-12-06 kafei

    了解一下谢谢

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1651213, encodeId=55be16512131b, content=<a href='/topic/show?id=1e61555223e' target=_blank style='color:#2F92EE;'>#抗癌新药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55522, encryptionId=1e61555223e, topicName=抗癌新药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a6224143528, createdName=zhangmingxiang, createdTime=Sun Dec 23 17:23:00 CST 2018, time=2018-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676918, encodeId=8bf116e6918d6, 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=64, 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=Tue Mar 12 02:23:00 CST 2019, time=2019-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=354964, encodeId=73ad354964d4, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Dec 09 23:49:51 CST 2018, time=2018-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339149, encodeId=63441339149ed, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Fri Dec 07 14:23:00 CST 2018, time=2018-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=354605, encodeId=1d023546055c, content=了解一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Thu Dec 06 09:40:32 CST 2018, time=2018-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=354571, encodeId=9e6d3545e110, content=学习了,谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Wed Dec 05 23:39:11 CST 2018, time=2018-12-05, status=1, ipAttribution=)]
    2018-12-05 惠映实验室

    学习了,谢谢分享。

    0

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