损失惨重:22家药企被收回GMP证书

  • 药企,GMP证书,药品GMP证书
  • 赛柏蓝



广东省食品药品监督管理局于9月10日、9月16日分三次发布收回药品GMP证书的公告,共涉及药企13家。如此集中地“收回公告”,着实让人感到有些意外。GMP证书事关药品能否生产,对企业的生产经营影响重大。自2013年10月以来,至少有21家药企GMP证书被收回,其中一家被注销。


这22家被收回证书的企业分布在广东、广西、吉林、内蒙古和湖北,其中广东13家,广西4家,吉林3家,内蒙古和湖北各1家。


在广东被收回的11张GMP证书中,有11家的认证范围为中药饮片,另外两家为:片剂、颗粒剂、中药前处理及提取车间;口服液、中药前处理及提取车间。




哪些原因致GMP证书被收回?


据新版GMP管理办法规定,有下列情况之一的,由药品监督管理部门收回《药品GMP证书》:企业(车间)不符合药品GMP要求的;企业因违反药品管理法规被责令停产整顿的;其他需要收回的。


《办法》还规定,有下列情况之一的,由原发证机关注销《药品GMP证书》:企业《药品生产许可证》依法被撤销、撤回,或者依法被吊销的;企业被依法撤销、注销生产许可范围的;企业《药品GMP证书》有效期届满未延续的;其他应注销《药品GMP证书》的。


由于各地收回GMP证书的公告文件并没有公开具体的原因,我们也不知上述被收回证书的企业,到底是违反了哪条规定。


被收回GMP证书之后


GMP证书被收回之后,一般会让企业有一个整改的时间,这期间暂停药品生产。整改并通过检查合格后,药监部门会发回证书。但在上述几个省份的药监官网上,很少看到发回证书的公告,表明一年以来上述几省多数被收回的GMP证书,还没有拿回。


这也意味着企业涉事车间可能处于停产状态,对企业的生产经营影响不言而喻,说到损失惨重也不为过,因违规所付出的代价可谓不低。


顺便提个建议,CFDA有一个名为“药品GMP证书收(发)回公告”的小栏目,2013年11月还在更新,收录各省的公告情况,但往后就再也没有更新,像吉林、广东、湖北、内蒙古等省区的收回公告,均没有收录,建议完善一下。

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