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CDE公开征求《人源性干细胞产品药学研究与评价技术指导原则（征求意见稿）》意见

2021-08-17 CDE CDE

人源性干细胞
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8月17日，CDE公开征求《人源性干细胞产品药学研究与评价技术指导原则（征求意见稿）》意见。

8月17日，国家药监局药审中心（CDE）网站发布关于公开征求《人源性干细胞产品药学研究与评价技术指导原则（征求意见稿）》意见的通知，全文如下。
为规范和引导人源性干细胞产品的药学研究，我中心在前期调研的基础上，结合国内外相关法规和技术要求，以及对这类产品当前技术发展和科学的认知，形成了《人源性干细胞产品药学研究与评价技术指导原则（征求意见稿）》。现通过中心网站（www.cde.org.cn）向社会公开征求意见，诚挚欢迎社会各界对征求意见稿提出宝贵意见和建议，请在征求意见反馈表填写具体信息，并通过邮件反馈我们。感谢您的参与和支持！

联系人：

韩冬梅，Email：handm@cde.org.cn；

魏开坤，Email：weikk@cde.org.cn；

征求意见截至时间：2021年9月17日。

  国家药品监督管理局药品审评中心

2021年8月17日

征求意见详情如下：

 

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评论区 (6)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1949972, encodeId=335a19499e2b7, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Mon Sep 13 11:16:02 CST 2021, time=2021-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2009779, encodeId=d1d02009e79dd, content=<a href='/topic/show?id=8d6750352ef' target=_blank style='color:#2F92EE;'>#征求意见稿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50352, encryptionId=8d6750352ef, topicName=征求意见稿)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Apr 11 23:16:02 CST 2022, time=2022-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025575, encodeId=2e5210255e521, content=干细胞是热点，但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Fri Aug 20 14:16:02 CST 2021, time=2021-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444714, encodeId=56071444e14c6, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515194, encodeId=f82c15151945a, 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=39, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008698, encodeId=7668100869837, content=干细胞研究是双刃剑，权衡利弊。, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Aug 17 14:25:56 CST 2021, time=2021-08-17, status=1, ipAttribution=)]
    2021-09-13 zhaohui6731

    #征求意见#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1949972, encodeId=335a19499e2b7, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Mon Sep 13 11:16:02 CST 2021, time=2021-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2009779, encodeId=d1d02009e79dd, content=<a href='/topic/show?id=8d6750352ef' target=_blank style='color:#2F92EE;'>#征求意见稿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50352, encryptionId=8d6750352ef, topicName=征求意见稿)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Apr 11 23:16:02 CST 2022, time=2022-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025575, encodeId=2e5210255e521, content=干细胞是热点，但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Fri Aug 20 14:16:02 CST 2021, time=2021-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444714, encodeId=56071444e14c6, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515194, encodeId=f82c15151945a, 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=39, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008698, encodeId=7668100869837, content=干细胞研究是双刃剑，权衡利弊。, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Aug 17 14:25:56 CST 2021, time=2021-08-17, status=1, ipAttribution=)]
    2022-04-11 smlt2008

    #征求意见稿#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1949972, encodeId=335a19499e2b7, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Mon Sep 13 11:16:02 CST 2021, time=2021-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2009779, encodeId=d1d02009e79dd, content=<a href='/topic/show?id=8d6750352ef' target=_blank style='color:#2F92EE;'>#征求意见稿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50352, encryptionId=8d6750352ef, topicName=征求意见稿)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Apr 11 23:16:02 CST 2022, time=2022-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025575, encodeId=2e5210255e521, content=干细胞是热点，但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Fri Aug 20 14:16:02 CST 2021, time=2021-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444714, encodeId=56071444e14c6, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515194, encodeId=f82c15151945a, 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=39, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008698, encodeId=7668100869837, content=干细胞研究是双刃剑，权衡利弊。, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Aug 17 14:25:56 CST 2021, time=2021-08-17, status=1, ipAttribution=)]
    2021-08-20 独孤立克

    干细胞是热点，但是进入临床仍然需要时间和临床疗效验证哦

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1949972, encodeId=335a19499e2b7, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Mon Sep 13 11:16:02 CST 2021, time=2021-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2009779, encodeId=d1d02009e79dd, content=<a href='/topic/show?id=8d6750352ef' target=_blank style='color:#2F92EE;'>#征求意见稿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50352, encryptionId=8d6750352ef, topicName=征求意见稿)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Apr 11 23:16:02 CST 2022, time=2022-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025575, encodeId=2e5210255e521, content=干细胞是热点，但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Fri Aug 20 14:16:02 CST 2021, time=2021-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444714, encodeId=56071444e14c6, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515194, encodeId=f82c15151945a, 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=39, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008698, encodeId=7668100869837, content=干细胞研究是双刃剑，权衡利弊。, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Aug 17 14:25:56 CST 2021, time=2021-08-17, status=1, ipAttribution=)]
    2021-08-19 huagfeg

    #评价#

    0

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    2021-08-19 12498a1cm70暂无昵称

    #技术指导原则#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1949972, encodeId=335a19499e2b7, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Mon Sep 13 11:16:02 CST 2021, time=2021-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2009779, encodeId=d1d02009e79dd, content=<a href='/topic/show?id=8d6750352ef' target=_blank style='color:#2F92EE;'>#征求意见稿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50352, encryptionId=8d6750352ef, topicName=征求意见稿)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Apr 11 23:16:02 CST 2022, time=2022-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025575, encodeId=2e5210255e521, content=干细胞是热点，但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Fri Aug 20 14:16:02 CST 2021, time=2021-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444714, encodeId=56071444e14c6, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515194, encodeId=f82c15151945a, 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=39, 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=Thu Aug 19 05:16:02 CST 2021, time=2021-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008698, encodeId=7668100869837, content=干细胞研究是双刃剑，权衡利弊。, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Tue Aug 17 14:25:56 CST 2021, time=2021-08-17, status=1, ipAttribution=)]
    2021-08-17 yangchou

    干细胞研究是双刃剑，权衡利弊。

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