药械

订阅

MedSci主页 / 所有栏目 / 药械

生物制品新分类 细胞治疗按药品注册上市

2017-10-26 仲夏秋夜云 蒲公英

生物制品药品注册细胞治疗
关注

生物制品新分类，细胞治疗按药报！

生物制品新分类，细胞治疗按药报！

谁也没想到，在总局发布了药品注册管理办法征求意见稿之后，各大媒体都进行了解读，解读之后，他们居然又挂上了一个压缩包…我相信，所有的媒体当时都没有看到。不然不会有人漏掉那么重大的新闻。



1.生物制品新分类

和花妖一样，生物制品也这么分类了，新药，仿制品主线，进口单独。

2.生物制品有CTD格式了

不仅有了格式，而且把每一部分的要求，哪些东西应该报临床的时候，做完哪些应该报生产的时候做完写得非常详细。

3.治疗用生物制品可以按药报

之前很多公司选择技术手段三类，也有人抱怨，如果按照药品报没有太多的机会和途径。现在明确有了，但是不知道这些企业看到这张资料表会作何感想。按药报就按药的要求来。

4.预防用生物制品这次也在分类里

我们有很多法规，用生物制品都是单独成本的。这次的分类方式，预报用生物制品，也是按此规矩分成了五类。只有一个小毛病，在预防用生物制品的分类里把他写成了治疗用生物制品。



总结一下，让子弹飞一下，重复的刷新几下，会有新的惊喜



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 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1440612, encodeId=1d0614406123d, content=<a href='/topic/show?id=eeeb8e444e6' target=_blank style='color:#2F92EE;'>#药品注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87444, encryptionId=eeeb8e444e6, topicName=药品注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3f64741524, createdName=1508842480_96220438, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476246, encodeId=f93714e624673, content=<a href='/topic/show?id=ae0669226c3' target=_blank style='color:#2F92EE;'>#生物制品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69226, encryptionId=ae0669226c3, topicName=生物制品)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dd657261208, createdName=楚钟, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556783, encodeId=0a441556e83a2, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=256114, encodeId=2229256114da, content=很好的文章.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 26 12:24:49 CST 2017, time=2017-10-26, status=1, ipAttribution=)]
    2017-10-28 1508842480_96220438

    #药品注册#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1440612, encodeId=1d0614406123d, content=<a href='/topic/show?id=eeeb8e444e6' target=_blank style='color:#2F92EE;'>#药品注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87444, encryptionId=eeeb8e444e6, topicName=药品注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3f64741524, createdName=1508842480_96220438, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476246, encodeId=f93714e624673, content=<a href='/topic/show?id=ae0669226c3' target=_blank style='color:#2F92EE;'>#生物制品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69226, encryptionId=ae0669226c3, topicName=生物制品)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dd657261208, createdName=楚钟, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556783, encodeId=0a441556e83a2, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=256114, encodeId=2229256114da, content=很好的文章.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 26 12:24:49 CST 2017, time=2017-10-26, status=1, ipAttribution=)]
    2017-10-28 楚钟

    #生物制品#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1440612, encodeId=1d0614406123d, content=<a href='/topic/show?id=eeeb8e444e6' target=_blank style='color:#2F92EE;'>#药品注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87444, encryptionId=eeeb8e444e6, topicName=药品注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3f64741524, createdName=1508842480_96220438, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476246, encodeId=f93714e624673, content=<a href='/topic/show?id=ae0669226c3' target=_blank style='color:#2F92EE;'>#生物制品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69226, encryptionId=ae0669226c3, topicName=生物制品)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dd657261208, createdName=楚钟, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556783, encodeId=0a441556e83a2, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=256114, encodeId=2229256114da, content=很好的文章.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 26 12:24:49 CST 2017, time=2017-10-26, status=1, ipAttribution=)]
    2017-10-28 zhyy93

    #注册#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1440612, encodeId=1d0614406123d, content=<a href='/topic/show?id=eeeb8e444e6' target=_blank style='color:#2F92EE;'>#药品注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87444, encryptionId=eeeb8e444e6, topicName=药品注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3f64741524, createdName=1508842480_96220438, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476246, encodeId=f93714e624673, content=<a href='/topic/show?id=ae0669226c3' target=_blank style='color:#2F92EE;'>#生物制品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69226, encryptionId=ae0669226c3, topicName=生物制品)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dd657261208, createdName=楚钟, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556783, encodeId=0a441556e83a2, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Sat Oct 28 02:44:00 CST 2017, time=2017-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=256114, encodeId=2229256114da, content=很好的文章.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 26 12:24:49 CST 2017, time=2017-10-26, status=1, ipAttribution=)]
    2017-10-26 清风拂面

    很好的文章.学习了

    0

相关资讯

全球CAR-T临床研究项目盘点：4年新增项目数量翻4.5倍

我国的CAR-T研究虽然起步不算早，但从2013年增长迅猛。目前，我国的临床研究项目位于全球第二，仅次于美国。

食药监管总局公布2015年度药品上市批准情况

为进一步提高药品审评审批透明度，有效指导药物研发申报及药品临床应用，食品药品监管总局日前发布公告，公布了《2015年批准上市的中药、天然药物目录》、《2015年批准上市的化学药品目录》、《2015年批准上市的生物制品目录》。   据统计,2015年度食品药品监管总局共批准中药、天然药物上市注册申请76个，化学药品上市注册申请241个，生物制品上市注册申请25个。详细信息请查阅《国