Nearly 2000 pharmaceutical companies GMP adjustment has been discontinued, the pharmaceutical indust-www.09955.com

Nearly 2000 companies have been shut down GMP adjustment of the pharmaceutical industry will meet the tide gauge nearly 2000 pharmaceutical companies in the pharmaceutical industry production will cater to the tide gauge reporter Zhu Ping reported in Beijing in February 23rd, the Jiangsu provincial food and Drug Administration issued a notice to recover the Liye pharmaceutical Limited by Share Ltd GMP certificate. Since January 1, 2015, a total of 155 pharmaceutical company GMP certificates have been recovered. According to the data released by the State Food and drug administration, as of January 13th, there were 7179 pharmaceutical manufacturers in China, and 1795 enterprises failed to pass the certification. The company has not passed the certification and been recovered nearly 2000, and in accordance with the provisions of the current production workshop without GMP certification will stop production. Beijing Dingchen pharmaceutical management consulting center director Shi Lichen to the twenty-first Century economic report, many did not pass the GMP certification of enterprises are small enterprises, and give up the GMP certification which can not afford the cost of some traditional Chinese medicine production enterprises directly to the health care market, and many rely on a small batch production enterprises directly choose to exit the market. "Not through the new version of GMP and lead to the phenomenon of the production of the current pharmaceutical market structure is not affected, most of the enterprises that have not passed the certification should be in recent years has been in the state of shutdown.". However, the biggest deterrent for pharmaceutical companies should be ‘flying inspection’, which puts forward higher compliance requirements for the production process and process of enterprises, while the other is the new drug registration and approval in 2015, which is the solution to the source compliance problem." An insider who did not want to be named said. Behind the GMP "AB" Zhang Ye (a pseudonym), a northern medicine production pharmaceutical companies responsible person, because recently to bid farewell to the pharmaceutical industry and trouble, no interview. Zhang run is a small pharmaceutical companies, last year because of failure to pass the GMP certification. Zhang earlier calculations, the annual revenue of 200-300 million yuan, and GMP certification should be at least 40 million yuan cost, so difficult to give up the certification decision, the plant and equipment sold recently prepared to its nearly 80 pharmaceutical production batch sale, completely abandoned the pharmaceutical industry. "Hope to have the opportunity to do the medicine industry again. After all these years, we are familiar with the industry and have accumulated some contacts and markets."." Zhang industry is helpless. In twenty-first Century, two other Chinese medicine manufacturers, which failed to pass the GMP certification, were directly converted into health care products. It is easier to make medicine production line into health care products, and medicine is usually more strict than health care products production process. And health care products from the previous approval system into a record system, previously to obtain approval of the "blue hat" is very difficult." According to the State Food and Drug Administration requirements, the existing drug production enterprises in addition to blood products, vaccines, injection of sterile drug production, should meet the requirements of the new version of GMP in December 31, 2015. Since the State Food and drug administration put forward this requirement, many small enterprises are in wait-and-see state. According to the Shaanxi food and Drug Administration informed that, as of the end of June 2015, Shaanxi province completed the new GMP recognition theory

近2000家药企GMP调整被停产 医药行业将迎合规大潮   近2000家药企停产 医药行业将迎合规大潮   本报记者 朱萍 北京报道   2月23日,江苏省食药监局发布公告,收回立业制药股份有限公司的GMP证书。从2015年1月1日起截至目前,全国共有155家药企GMP证书被收回。另据国家食药监总局公布的数据,截至1月13日,全国有药品生产企业7179家,有1795家企业未通过认证。未通过认证及被收回的近2000家,而按照规定,目前无GMP认证的企业生产车间一律停止生产。   北京鼎臣医药管理咨询中心负责人史立臣向21世纪经济报道介绍,很多未通过GMP认证的企业都是小企业,因为无法负担成本而放弃GMP认证,部分中药生产企业直接转做保健品市场,而很多靠生产批号过活的小企业直接选择退出市场。   “未通过新版GMP而导致停产的现象对目前医药市场格局影响并不大,目前未通过认证的企业有大部分应当是近几年来一直处于停产状态。但是对于药企最大威慑力的应该是‘飞检’,这对企业的生产工艺、流程等提出了更高的合规要求;另一个则是2015年力度较大的新药注册审批,这是解决源头合规问题。”一位不愿具名的业内人士表示。   GMP背后“AB”面   张业(化名),北方某普药生产药企负责人,近日因为要告别医药行业而伤神,无心接受采访。张业经营的是一家小药企,去年因未通过GMP认证停产。张业此前算了一笔账,其每年营收200-300万元,而进行GMP认证至少要4000万元的成本,于是艰难地做出放弃认证的决定,将厂房、设备等卖掉,近日又准备将旗下近80个药品生产批号出售,彻底放弃医药行业。“希望以后能有机会再做回医药行业,毕竟做了这么多年,对行业熟悉、也有积攒了一些人脉与市场。”张业很无奈。   而21世纪经济报道了解到的另两家未通过GMP认证的中药生产企业,他们则直接转成做保健品。“做医药的生产线转成保健品生产比较容易,医药通常比保健品生产工艺等要求更严格。而且保健品由以前的审批制改成备案制了,以前要获得审批的‘蓝帽子’非常难。”   按国家食药监总局要求,现有药品生产企业除血液制品、疫苗、注射剂等无菌药品生产外,应在2015年12月31日前达到新版GMP要求。   自从国家食药监总局提出这要求后,很多小的企业处于观望的状态。据陕西食药监局通报显示,截至2015年6月底,陕西省完成新版GMP认证的企业占比为60%,即虽然新版GMP是2011年出台的,但是却有至少40%的企业扎堆在大限前半年才认证。   史立臣向21世纪经济报道记者分析称,很多未通过GMP认证的企业都类似上述几个企业,很多是从成本来考虑的。“握着多个有价值的药品批文,即使没有通过新版GMP认证,短期内可与通过新版GMP认证的大型实力企业加速并购整合,但未来随着新药审批制度的改革,药品批文的优势也会相对减弱。”   而对于体量相对较大的企业而言,新建生产线可提高产能,提高企业的品牌建设。早在2013年,贵州百灵即开始在着手生产车间改造GMP认证事宜,其董秘牛民向21世纪经济报道记者表示,新的GMP认证推广是国家势在必行的,也可以促进药企对质量的严格管理及提高。“想继续发展的企业,必须进行相关认证的,早晚都要建,早点建成对企业自身发展也有很大的好处。新生产线在安全、质量上都可以得到提升。”   “中国药厂太多,行业分散,又良莠不齐。而且产能过剩,市场上药品同质化严重,新版GMP认证能‘倒逼’规范产品,提升质量,还能通过提高要求和标准让产业自然淘汰。设置GMP门槛淘汰一些产品本身就缺乏竞争力的中小企业,整合行业市场。”史立臣表示。   史上最严飞检   实际上,目前对医药企业威慑力最大的是“飞检”,因为即使药企通过了GMP认证,但若在生产中的任何一个环节发现问题,证书就可能会被收回。   2015年年初,国家药监总局公布了《药品飞行检查办法(草案)》后,全国共有140家药企144张GMP证书被收回。而自今年1月1日起,国家食药监总局将不再承担GMP认证检查任务,所有的GMP认证检查都由各省承担。   “将GMP认证下放到省里后,相关认证的进程会加快些,此前企业进行认证还需要2-3个月的排队时间。但这并不意味着省里可以对企业随意‘放水’,因为总局还有问责等相关机制,从严的原则是不会变的。”史立臣表示。   目前,药品监管逐渐强化,各省份也相应开展了飞检活动。2月23日,江苏省食药监局发布公告,收回立业制药股份有限公司的GMP证书,这是江苏省2016年以来被收回的第一张GMP证书,同时也是全国范围内被收回的第15张。   同在2月23日,安徽省药监局发布通知,印发《2016年药品GMP跟踪飞行检查工作方案》,将对全省持有《药品GMP证书》的药品生产企业开展药品GMP跟踪飞行检查。重点检查内容包括重点检查品种、重点检查企业、重点检查环节三个方面。据安徽省药监局官方数据显示,安徽省目前持有《药品GMP证书》的药品生产企业共有236家。   与此同时,不久前安徽省食药监局发布《关于开展药品生产工艺和处方登记工作的通知》。根据通知内容,将开展药品生产工艺和处方登记工作,建立处方工艺数据库,凡不按入库的批准工艺和处方生产药品的,将以不符合GMP论处,收回其GMP证书。有业内分析人士指出,这项规定在全国属于首创,擅自变更工艺及处方将遭重罚,在飞检严查的形势下,各药企更应注意合规性。   而另一方面,国家食药监总局亦在加强源头的合规性。2015年7月,国家启动药物临床试验数据自查核查工作,对待批生产的1622个药物临床试验项目数据真实性、规范性进行核查,并分3批派出20个检查组开展现场核查。截至2016年1月12日,撤回和不通过合计1151个,占自查核查总数的80%,其中企业主动撤回占到77%,剩余待核查项目273个。 进入【新浪财经股吧】讨论相关的主题文章: