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CFDA重磅消息:第一批通过仿制药一致性评价品种公布!

2017-12-29 CFDA CFDA

根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)、《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》(国办发〔2016〕8号)、《关于仿制药质量和疗效一致性评价工作有关事项的公告》(国家食品药品监督管理总局公告2017年第100号)的规定,经审查,现发布符合仿制药质量和疗效一致性评价要求的药品申请品种目录

根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)、《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》(国办发〔2016〕8号)、《关于仿制药质量和疗效一致性评价工作有关事项的公告》(国家食品药品监督管理总局公告2017年第100号)的规定,经审查,现发布符合仿制药质量和疗效一致性评价要求的药品申请品种目录


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  1. [GetPortalCommentsPageByObjectIdResponse(id=1906858, encodeId=602d1906858d1, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Thu Jun 28 20:36:00 CST 2018, time=2018-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890691, encodeId=862b189069158, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, 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 Jul 31 11:36:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261373, encodeId=a51c12613e35d, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sun Dec 31 07:36:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444315, encodeId=564b1444315ab, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sun Dec 31 07:36:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549254, encodeId=1306154925452, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sun Dec 31 07:36:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273607, encodeId=55732e36077d, content=学习了受益匪浅, 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/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Fri Dec 29 19:37:34 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273546, encodeId=1e252e354608, content=根据<中华人民共和国药品管理法>.<国务院关于改革药品医疗器械审评审批制度的意见>(国发[2015]44号).<国务院办公厅关于开展仿制药质量和疗效一致性评价的意见>(国办发[2016]8号).<关于仿制药质量和疗效一致性评价工作有关事项的公告>(国家食品药品监督管理总局公告2017年第100号)的规定.经审查.现发布符合仿制药质量和疗效一致性评价要求的药品申请品种目录, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Fri Dec 29 17:02:38 CST 2017, time=2017-12-29, status=1, ipAttribution=)]
    2018-06-28 zhanfl
  2. [GetPortalCommentsPageByObjectIdResponse(id=1906858, encodeId=602d1906858d1, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Thu Jun 28 20:36:00 CST 2018, time=2018-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890691, encodeId=862b189069158, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, 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 Jul 31 11:36:00 CST 2018, time=2018-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261373, encodeId=a51c12613e35d, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sun Dec 31 07:36:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444315, encodeId=564b1444315ab, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sun Dec 31 07:36:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549254, encodeId=1306154925452, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sun Dec 31 07:36:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273607, encodeId=55732e36077d, content=学习了受益匪浅, 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/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Fri Dec 29 19:37:34 CST 2017, time=2017-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273546, encodeId=1e252e354608, content=根据<中华人民共和国药品管理法>.<国务院关于改革药品医疗器械审评审批制度的意见>(国发[2015]44号).<国务院办公厅关于开展仿制药质量和疗效一致性评价的意见>(国办发[2016]8号).<关于仿制药质量和疗效一致性评价工作有关事项的公告>(国家食品药品监督管理总局公告2017年第100号)的规定.经审查.现发布符合仿制药质量和疗效一致性评价要求的药品申请品种目录, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Fri Dec 29 17:02:38 CST 2017, time=2017-12-29, status=1, ipAttribution=)]
    2018-07-31 stfoxst
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    2017-12-31 drwjr
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    2017-12-31 huagfeg
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    2017-12-31 xxxx1054
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    2017-12-29 131****1460

    学习了受益匪浅

    0

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    2017-12-29 有备才能无患

    根据<中华人民共和国药品管理法>.<国务院关于改革药品医疗器械审评审批制度的意见>(国发[2015]44号).<国务院办公厅关于开展仿制药质量和疗效一致性评价的意见>(国办发[2016]8号).<关于仿制药质量和疗效一致性评价工作有关事项的公告>(国家食品药品监督管理总局公告2017年第100号)的规定.经审查.现发布符合仿制药质量和疗效一致性评价要求的药品申请品种目录

    0

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