关于《社区获得性细菌性肺炎抗菌药物研发临床试验技术指导原则》和《急性细菌性皮肤与皮肤结构感染抗菌药物研发临床试验技术指导原则》征求意见的通知

2020-03-26 CDE CDE

各有关单位:

各有关单位:
       为贯彻落实国务院《关于改革药品医疗器械审审批制度的意见》(国发【2015】44号)的有关要求,鼓励研究和创制新药,加快创新抗菌药物研发与评价技术指南体系的建设,我中心现已完成《社区获得性细菌性肺炎抗菌药物研发临床试验技术指导原则(网上征求意见稿)》和《急性细菌性皮肤与皮肤结构感染抗菌药物研发临床试验技术指导原则(网上征求意见稿)》的起草工作,现向社会公开征求意见。如有意见,请于2020年4月17日前通过电子邮件反馈至我中心。
       联系人:赵明   翟云
       电子邮件:zhaom@cde.org.cn   zhaiy@cde.org.cn
       联系电话:85242770   85242750

附件 1 : CAP抗菌药物临床试验技术指导原则.docx
附件 2 : 皮肤软组织 抗菌药物临床试验技术指导原则.docx

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    2020-03-28 lqvr
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  5. 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  6. 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createdBy=8cab9069092, createdName=hjwang82, createdTime=Sat Mar 28 06:00:16 CST 2020, time=2020-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515184, encodeId=f7d4151518408, content=<a href='/topic/show?id=ff10548e973' target=_blank style='color:#2F92EE;'>#技术指导原则#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54879, encryptionId=ff10548e973, topicName=技术指导原则)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3ba310728503, createdName=12498a1cm70暂无昵称, createdTime=Sat Mar 28 06:00:16 CST 2020, time=2020-03-28, status=1, ipAttribution=)]
    2020-03-28 lhlxtx
  7. 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