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总局调整部分药品和医疗器械行政审批事项审批程序

2017-04-06 佚名 CFDA中国食品药品监管

为优化药品和医疗器械审评审批流程,提高审评审批效率,日前,食品药品监管总局发布总局令31号《国家食品药品监督管理总局关于调整部分药品行政审批事项审批程序的决定》和总局令32号《国家食品药品监督管理总局关于调整部分医疗器械行政审批事项审批程序的决定》,对食品药品监管总局负责的临床试验审批事项、再注册和延续注册审批事项、注册变更审批事项等药品和医疗器械行政审批事项的审批程序进行调整。 从2017年5月

为优化药品和医疗器械审评审批流程,提高审评审批效率,日前,食品药品监管总局发布总局令31号《国家食品药品监督管理总局关于调整部分药品行政审批事项审批程序的决定》和总局令32号《国家食品药品监督管理总局关于调整部分医疗器械行政审批事项审批程序的决定》,对食品药品监管总局负责的临床试验审批事项、再注册和延续注册审批事项、注册变更审批事项等药品和医疗器械行政审批事项的审批程序进行调整。
 
从2017年5月1日起,国产和进口药物的临床试验审批决定、国产和进口药品的补充申请审批决定、进口药品再注册审批决定,调整为由总局药品审评中心以总局名义作出,审批决定由药品审评中心负责人签发。
 
从2017年7月1日起,第三类高风险医疗器械临床试验审批决定、国产第三类医疗器械和进口医疗器械许可事项变更审批决定、国产第三类医疗器械和进口医疗器械延续注册审批决定,由总局医疗器械审评中心以总局名义作出,审批决定由总局医疗器械技术审评中心负责人签发。

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  1. 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content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, 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    2017-04-08 1771ae4158m

    学习一下很不错

    0

  2. 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likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Apr 07 07:52:45 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185676, encodeId=dbee1856e68c, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Apr 07 07:16:24 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185657, encodeId=972c18565ee7, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, 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    2017-04-08 lou.minghong

    学习了

    0

  3. 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content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=20971999626, createdName=laymankey, createdTime=Fri Apr 07 00:06:44 CST 2017, time=2017-04-07, status=1, ipAttribution=)]
    2017-04-07 1ddf0692m34(暂无匿称)

    希望对老百姓有用

    0

  4. 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    2017-04-07 1e10c84am36(暂无匿称)

    文章不错,值得分享

    0

  5. 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    2017-04-07 shaosai

    好好学习,涨知识

    0

  6. 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    2017-04-07 明月清辉

    1398504075

    0

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content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=20971999626, createdName=laymankey, createdTime=Fri Apr 07 00:06:44 CST 2017, time=2017-04-07, status=1, ipAttribution=)]
    2017-04-07 飛歌

    学习了很有用

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=185932, encodeId=a32a18593229, content=学习一下很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/11/23/ac01daf0962458a9eb8c0b1e2f6ce5bc.jpg, createdBy=04b81710322, createdName=1771ae4158m, createdTime=Sat Apr 08 07:59:31 CST 2017, time=2017-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185880, encodeId=23fc185880dd, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Sat Apr 08 04:43:14 CST 2017, time=2017-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185808, encodeId=8e76185808f7, content=希望对老百姓有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, 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=Fri Apr 07 17:09:17 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185721, encodeId=c4ad185e21d9, content=文章不错,值得分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Apr 07 09:00:39 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185702, encodeId=43a9185e0237, content=好好学习,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://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLANEL7Sww3HicKsN9aribicAmGGWXOIMEiaZ1iadgZg9RibjqSwIKUS8gSPib2NwTVg2zVvVJhdP3BkuDIl/0, createdBy=944d1605392, createdName=shaosai, createdTime=Fri Apr 07 08:22:34 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185694, encodeId=7570185694ec, content=1398504075, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Apr 07 07:52:45 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185676, encodeId=dbee1856e68c, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Apr 07 07:16:24 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185657, encodeId=972c18565ee7, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=20971999626, createdName=laymankey, createdTime=Fri Apr 07 00:06:44 CST 2017, time=2017-04-07, status=1, ipAttribution=)]
    2017-04-07 刘煜

    阅读了谢谢分享

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=185932, encodeId=a32a18593229, content=学习一下很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/11/23/ac01daf0962458a9eb8c0b1e2f6ce5bc.jpg, createdBy=04b81710322, createdName=1771ae4158m, createdTime=Sat Apr 08 07:59:31 CST 2017, time=2017-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185880, encodeId=23fc185880dd, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Sat Apr 08 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likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Apr 07 07:52:45 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185676, encodeId=dbee1856e68c, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Apr 07 07:16:24 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185657, encodeId=972c18565ee7, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=20971999626, createdName=laymankey, createdTime=Fri Apr 07 00:06:44 CST 2017, time=2017-04-07, status=1, ipAttribution=)]
    2017-04-07 yfjms

    感谢分享,学习了

    0

  10. [GetPortalCommentsPageByObjectIdResponse(id=185932, encodeId=a32a18593229, content=学习一下很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/11/23/ac01daf0962458a9eb8c0b1e2f6ce5bc.jpg, createdBy=04b81710322, createdName=1771ae4158m, createdTime=Sat Apr 08 07:59:31 CST 2017, time=2017-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185880, encodeId=23fc185880dd, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib2JlGvwpAibiaovVhfA9DbO7X7JLGGjM4Cic6oMgxLdnuS9piaP9cnG2OwIbkzHvX0qzS1boibyYNqR5vHZu7HQs5EIB/0, createdBy=298d1398341, createdName=lou.minghong, createdTime=Sat Apr 08 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likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Apr 07 07:52:45 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185676, encodeId=dbee1856e68c, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Fri Apr 07 07:16:24 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185657, encodeId=972c18565ee7, content=阅读了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Apr 07 06:08:55 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185638, encodeId=354818563819, content=感谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Fri Apr 07 00:18:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185629, encodeId=6b2d18562978, content=感谢分享一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=20971999626, createdName=laymankey, createdTime=Fri Apr 07 00:06:44 CST 2017, time=2017-04-07, status=1, ipAttribution=)]
    2017-04-07 laymankey

    感谢分享一下

    0

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