一致性评价:37个品种被50%以上企业放弃,109个品种最被企业看重

2017-08-23 医药魔方 医药魔方

8月21日,CFDA对外公布了国内企业的一致性评价工作开展情况,主要是对289目录上被业选择评价和放弃评价的品种进行了统计(截至2017年5月23日)。从以下2点简单看一下这个数据:一、至少37个品种被50%以上的药企抛弃根据CFDA公布的统计结果,被列入289目录需要在2018年底前完成评价的品种中,以下36个品种被一半以上大药企放弃。考虑到统计时间滞后以及评价成功率等因素,289品种里面,被5

8月21日,CFDA对外公布了国内企业的一致性评价工作开展情况,主要是对289目录上被业选择评价和放弃评价的品种进行了统计(截至2017年5月23日)。从以下2点简单看一下这个数据:

一、至少37个品种被50%以上的药企抛弃

根据CFDA公布的统计结果,被列入289目录需要在2018年底前完成评价的品种中,以下36个品种被一半以上大药企放弃。考虑到统计时间滞后以及评价成功率等因素,289品种里面,被50%以上企业放弃的品种预计也会远远超过37个。

在这37个品种中,磺胺嘧啶片、格列本脲片、阿司匹林片虽然也有很多企业未放弃,但真正开始评价的企业占比只有1/3左右。

50%以上企业放弃评价的品种

(表格中数字代表企业数量)

二、109个品种最被企业看重

有些品种被企业果断放弃,也有些品种被企业坚守不放,以下109个品种就被企业格外看重,超过80%的企业都表示不放弃。

这部分品种还有一个特点,企业比较果断,要么做,要么不做,很少出现企业待定犹豫不决的情况。比较有意思的一个品种是复方甘草片,36家生产企业,33家明确表示不放弃,但真正开始做的也就20家左右。


80%以上企业不愿放弃评价的品种

(表格中数字代表企业数量)


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    2018-03-29 zhanfl
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    2017-08-25 huagfeg
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    2017-08-25 hyf030
  4. [GetPortalCommentsPageByObjectIdResponse(id=1906847, encodeId=1e4e190684ee1, 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=21, 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 Mar 29 05:08:00 CST 2018, time=2018-03-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444247, encodeId=580d144424ebb, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, 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=Fri Aug 25 02:08:00 CST 2017, time=2017-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1456110, encodeId=12c814561109a, content=<a href='/topic/show?id=3cdb2563088' target=_blank style='color:#2F92EE;'>#企业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25630, encryptionId=3cdb2563088, topicName=企业)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a765759005, createdName=hyf030, createdTime=Fri Aug 25 02:08:00 CST 2017, time=2017-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236367, encodeId=54c823636e32, content=学习了.谢谢., beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Wed Aug 23 14:01:34 CST 2017, time=2017-08-23, status=1, ipAttribution=)]
    2017-08-23 惠映实验室

    学习了.谢谢.

    0

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