发改委:GMP/GSP认证费全取消

2018-01-04 遥望 赛柏蓝

2018年,医药人的第一个好消息,GMP/GSP认证收费文件被废止。据了解,这一利好已经于昨日(2018年1月1日)开始施行。

2018年,医药人的第一个好消息,GMP/GSP认证收费文件被废止。据了解,这一利好已经于昨日(2018年1月1日)开始施行。

近日,国家发改委发布《中华人民共和国国家发展和改革委员会令》(第12号),决定废止9个规章和143个规范性文件。



在废止的143个规范性文件中,第55个就是关于GMP、GSP认证收费的通知。



据了解,GMP认证费收费标准国家食品药品监督管理局药品认证管理中心(以下简称国家药品认证管理中心)在对申请药品GMP认证的生产注射剂、放射性药品和国务院药品监督管理部门规定的生物制品的企业进行初步技术审查时,收取受理申请费的收费标准为每个企业500元;

组织专家对申请药品GMP认证的生产注射剂、放射性药品和国务院药品监督管理部门规定的生物制品的企业进行实地勘验审核时收取审核费,收费标准为一个剂型(含一条生产线)30000元,每增加一个剂型可加收3000元。取消国家药品认证管理中心向获得GMP证书企业收取的年费。

GSP认证费收费标准含受理申请费和审核费,各省、自治区、直辖市药品认证管理机构对本辖区内的药品经营企业进行 GSP认证,向申请企业收取。收费标准由企业所在地省、自治区、直辖市价格主管部门会同财政部门制定,并报国家发展改革委、财政部备案。

就像我们的生命再也不可能踏进2017的河流,我们永远地告别了2017。伴随发改委一纸政令,GMP/GSP认证收费也淹没在了历史的尘埃里。而无疑取消GMP/GSP认证收费正是取消GMP/GSP认证的伏笔。

附:《中华人民共和国国家发展和改革委员会令》(第12号)全文

“为贯彻落实党中央、国务院关于“简政放权、放管结合、优化服务”改革和生态文明建设、环境保护等要求,经商国务院相关部门,现决定废止《关于印发〈关于改进工程建设概预算定额管理工作的若干规定〉等三个文件的通知》等9件规章和《关于颁发〈电力网电能损耗管理规定〉的通知》等143件规范性文件。本决定自2018年1月1日起施行。”

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    2018-01-05 hxq78316
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    2018-01-04 1ddf0692m34(暂无匿称)

    学习了.涨知识

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1952169, encodeId=81cb1952169b2, content=<a href='/topic/show?id=32648302fc' target=_blank style='color:#2F92EE;'>#GSP认证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8302, encryptionId=32648302fc, topicName=GSP认证)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Tue Jan 16 09:22:00 CST 2018, time=2018-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1636356, encodeId=0c92163635688, content=<a href='/topic/show?id=56f63e8706d' target=_blank style='color:#2F92EE;'>#发改委#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37870, encryptionId=56f63e8706d, topicName=发改委)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569522619490, createdName=ms6519009802973839, createdTime=Fri Nov 30 06:22:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376693, encodeId=56d113e6693d9, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Fri Jan 05 16:22:00 CST 2018, time=2018-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515513, encodeId=0b0a15155137c, content=<a href='/topic/show?id=5cc983010e' target=_blank style='color:#2F92EE;'>#GSP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8301, encryptionId=5cc983010e, topicName=GSP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6dd10815840, createdName=12498bb3m93(暂无昵称), createdTime=Fri Jan 05 16:22:00 CST 2018, time=2018-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=275298, encodeId=a1ec2e529818, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Thu Jan 04 07:46:21 CST 2018, time=2018-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=275249, encodeId=c5712e524906, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Thu Jan 04 06:48:23 CST 2018, time=2018-01-04, status=1, ipAttribution=)]
    2018-01-04 1dd8c52fm63(暂无匿称)

    了解了解.继续关注

    0

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