CFDA深化药品审评审批制度改革打出“组合拳”

2017-11-01 姚晓璐 医药地理  

10月28日,国家食品药品监督管理总局副局长、中国药学会理事长孙咸泽在中国药学会主办的2017年第十一届中国药物制剂大会上指出,食品药品监管总局将深入贯彻落实中共中央办公厅、国务院办公厅印发的《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》,进一步深化药品审评审批制度改革,以监管制度创新推动医药产业转型升级。


10月28日,国家食品药品监督管理总局副局长、中国药学会理事长孙咸泽在中国药学会主办的2017年第十一届中国药物制剂大会上指出,食品药品监管总局将深入贯彻落实中共中央办公厅、国务院办公厅印发的《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》,进一步深化药品审评审批制度改革,以监管制度创新推动医药产业转型升级。

消除积压,药品审评审批速度显著提高

当前我国已经是医药制造大国,但还不是医药创新强国,药品质量疗效还有差距,制药工业低水平重复问题仍然存在,药品研发、生产、经销等环节还存在问题,审评和监督力量薄弱,既影响和限制了医药产业的长远发展,也无法满足人民群众对药品安全有效的实际需求。2015年8月,国务院专门印发了《关于改革药品医疗器械审评审批制度的意见》,食品药品监管总局围绕提高药品质量改革,出台了一系列改革措施,以监管制度创新推动医药产业转型升级。

记者在会上了解到,目前,在审评中的药品注册基本消除积压,化药和疫苗临床试验申请,中药、民族药各类注册申请已经实现了按时限受理。截至当前共有353个药品注册申请纳入优先审评范围,其中40个儿童用药获得批准,一批全球新药物(如重组埃博拉病毒疫苗等)获得新药注册批准,一批创新药和临床急需药(如十三价肺炎球菌结合疫苗、贝那鲁肽注射液、苹果酸奈诺沙星胶囊等)获批上市。

上市许可人制度有序展开,仿制药一致性评价工作稳步推进

药品安全事关人民群众生命健康,党中央国务院历来高度重视,并采取了有力措施推动我国药物创新体系建设和创新能力提升,促进医药产业快速发展,调整结构和技术增长。新中国成立以来,特别是改革开放以来,药物创新体系建设加强,医药产业增速显著高于全球其他国家,成为全球第二大医药市场。2016年,规模以上医药工业销售收入2.8万亿元,同比增长9.7%,实现利润3000亿元,同比增长13.9%。

孙咸泽介绍,目前总局已经在10个省市开展药品上市许可人持有人制度试点,已经受理试点品种各类申请556件,完成审批128件,申报品种类型覆盖了药品研发机构、科研人员以及药品生产企业。

同时,仿制药质量和疗效一致性评价工作也在稳步推进。国务院在2016年2月专门印发了《关于开展仿制药质量和疗效一致性评价的意见》,在药品审评审批制度改革领导小组的统筹协调下,食品药品监管总局仿制药质量和疗效一致性评价办公室会同各有关单位落实各项任务。目前总局已经组织发布一致性评价各配套性文件25项,成立了以侯惠民院士为主任的由66位国内权威专家组成的一致性评价专家委员会,对参比制剂的核心问题开展审议工作,到目前为止,总局收到参比制剂近6000种,已经试批公告了近900个品规的参比制剂。

药品审评持续改革,将建立中国上市药品目录集

10月8日,中共中央办公厅、国务院办公厅印发了《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》,针对当前药品医疗器械创新面临的突出问题,着眼长远制度建设,提出了6个方面36条改革措施,主要是针对改革临床试验管理,加快上市审评审批速度,促进药品医疗器械创新和仿制药发展,加强药品和医疗器械全生命周期管理,提升技术支撑能力,加强组织领导等。

孙咸泽表示,围绕意见精神,食品药品监管总局将建立以审评为主导,检查检验为支撑的审评体系,实现检查、检验与审评并联推进,对临床急需有突破性疗效的药品、罕见病用药予以加快审评,允许可附带条件批准上市。为进一步推动仿制药质量疗效一致性评价,总局将建立中国上市药品目录集,注明所有药品各类信息,并建立药品档案,包括注册申请、临床研究、上市后评价、不良反应监测、检查检验抽验质量情况等,全部在档案中体现,并向社会公开。

同时,总局还将继续探索建立药品审评审批与药品专利链接制度、临床数据保护制度等一系列“组合拳”,并向全国全面实施上市许可持有人制度,完善技术审评体系和制度,加强审评检查能力建设,建设职业化检查人员队伍。《意见》从医药产业参与国际竞争,促进人民群众健康的战略高度,立足产业实际,放眼国际市场,对深化审评审批制度改革做出了积极、系统的制度设计,是今后几年药品监管和医药产业发展的纲领性文件,有利于鼓励创新,减少低水平重复,满足临床用药需求,最终促进医药产业的健康发展,对于贯彻落实党的十九大提出的建设创新型国家战略,激发医药产业创新发展活力,推进医药产业供给侧结构改革,提高中国药品质量和国际竞争力,更好的满足公众用药需求,推进健康中国建设,保障国家安全都具有十分重大的意义。

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=1890666, encodeId=3ba4189066657, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Fri Dec 29 17:36:00 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1717568, encodeId=fac11e1756826, content=<a href='/topic/show?id=c05be7634e8' target=_blank style='color:#2F92EE;'>#组合拳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77634, encryptionId=c05be7634e8, topicName=组合拳)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9ed332427480, createdName=hxj0128, createdTime=Mon Nov 06 16:36:00 CST 2017, time=2017-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1570426, encodeId=f09615e0426eb, content=<a href='/topic/show?id=98a18e3969d' target=_blank style='color:#2F92EE;'>#药品审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87396, encryptionId=98a18e3969d, topicName=药品审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b33b15654332, createdName=qingrejiedu, createdTime=Fri Nov 03 07:36:00 CST 2017, time=2017-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257849, encodeId=eb8525e84984, content=学习了吗受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Wed Nov 01 19:05:26 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257829, encodeId=852a25e8298e, content=学习学习.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Nov 01 17:02:32 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
    2017-12-29 stfoxst
  2. [GetPortalCommentsPageByObjectIdResponse(id=1890666, encodeId=3ba4189066657, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Fri Dec 29 17:36:00 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1717568, encodeId=fac11e1756826, content=<a href='/topic/show?id=c05be7634e8' target=_blank style='color:#2F92EE;'>#组合拳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77634, encryptionId=c05be7634e8, topicName=组合拳)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9ed332427480, createdName=hxj0128, createdTime=Mon Nov 06 16:36:00 CST 2017, time=2017-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1570426, encodeId=f09615e0426eb, content=<a href='/topic/show?id=98a18e3969d' target=_blank style='color:#2F92EE;'>#药品审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87396, encryptionId=98a18e3969d, topicName=药品审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b33b15654332, createdName=qingrejiedu, createdTime=Fri Nov 03 07:36:00 CST 2017, time=2017-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257849, encodeId=eb8525e84984, content=学习了吗受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Wed Nov 01 19:05:26 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257829, encodeId=852a25e8298e, content=学习学习.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Nov 01 17:02:32 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
    2017-11-06 hxj0128
  3. [GetPortalCommentsPageByObjectIdResponse(id=1890666, encodeId=3ba4189066657, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Fri Dec 29 17:36:00 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1717568, encodeId=fac11e1756826, content=<a href='/topic/show?id=c05be7634e8' target=_blank style='color:#2F92EE;'>#组合拳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77634, encryptionId=c05be7634e8, topicName=组合拳)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9ed332427480, createdName=hxj0128, createdTime=Mon Nov 06 16:36:00 CST 2017, time=2017-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1570426, encodeId=f09615e0426eb, content=<a href='/topic/show?id=98a18e3969d' target=_blank style='color:#2F92EE;'>#药品审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87396, encryptionId=98a18e3969d, topicName=药品审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b33b15654332, createdName=qingrejiedu, createdTime=Fri Nov 03 07:36:00 CST 2017, time=2017-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257849, encodeId=eb8525e84984, content=学习了吗受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Wed Nov 01 19:05:26 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257829, encodeId=852a25e8298e, content=学习学习.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Nov 01 17:02:32 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1890666, encodeId=3ba4189066657, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Fri Dec 29 17:36:00 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1717568, encodeId=fac11e1756826, content=<a href='/topic/show?id=c05be7634e8' target=_blank style='color:#2F92EE;'>#组合拳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77634, encryptionId=c05be7634e8, topicName=组合拳)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9ed332427480, createdName=hxj0128, createdTime=Mon Nov 06 16:36:00 CST 2017, time=2017-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1570426, encodeId=f09615e0426eb, content=<a href='/topic/show?id=98a18e3969d' target=_blank style='color:#2F92EE;'>#药品审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87396, encryptionId=98a18e3969d, topicName=药品审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b33b15654332, createdName=qingrejiedu, createdTime=Fri Nov 03 07:36:00 CST 2017, time=2017-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257849, encodeId=eb8525e84984, content=学习了吗受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Wed Nov 01 19:05:26 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257829, encodeId=852a25e8298e, content=学习学习.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Nov 01 17:02:32 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
    2017-11-01 131****1460

    学习了吗受益匪浅

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1890666, encodeId=3ba4189066657, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Fri Dec 29 17:36:00 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1717568, encodeId=fac11e1756826, content=<a href='/topic/show?id=c05be7634e8' target=_blank style='color:#2F92EE;'>#组合拳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77634, encryptionId=c05be7634e8, topicName=组合拳)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9ed332427480, createdName=hxj0128, createdTime=Mon Nov 06 16:36:00 CST 2017, time=2017-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1570426, encodeId=f09615e0426eb, content=<a href='/topic/show?id=98a18e3969d' target=_blank style='color:#2F92EE;'>#药品审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87396, encryptionId=98a18e3969d, topicName=药品审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b33b15654332, createdName=qingrejiedu, createdTime=Fri Nov 03 07:36:00 CST 2017, time=2017-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257849, encodeId=eb8525e84984, content=学习了吗受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Wed Nov 01 19:05:26 CST 2017, time=2017-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=257829, encodeId=852a25e8298e, content=学习学习.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Nov 01 17:02:32 CST 2017, time=2017-11-01, status=1, ipAttribution=)]
    2017-11-01 1dd8c52fm63(暂无匿称)

    学习学习.了解了解

    0