When the "two G certification" is about to be cancelled, the 51 pharmaceutical companies are in an awkward situation!

Recently (November 22-23), Guangdong Province, Chongqing City, Panjin City and Linyi City issued an announcement to withdraw 3 GMP certificates and 48 GSP certificates! In September this year, Wu Liya, deputy director of CFDA legal department, introduced the revision of the drug administration law at the "2016 first China pharmaceutical regulatory science conference", referring to the "key consideration of the revision content", she said that "appropriate reduction of administrative license: cancellation of GMP, GSP certification, etc." subsequently, many experts and media predicted that GMP, GSP certification might be cancelled The revision process of the drug administration law is speeding up, and the cancellation time of "two G Certifications" is predicted to be in the first half of next year If the revision progress of the drug administration law is fast enough, it will be published in March and April next year, at this time, the enterprises that have been revoked or withdrawn the GSP certification will be in an awkward situation: after the GSP certification has been withdrawn, if they meet the requirements of GSP after rectification, they can send back the GSP certification ; however, after the GSP certificate is revoked, it is necessary to stop operation and reapply for certification 6 months later The enterprises whose certificates have been revoked and received are as follows: today (November 23), Guangdong food and Drug Administration issued the notice on flight inspection of drug production supervision (No 11, 12 and 13 in 2016), and took back the GMP certificates of Guangdong Chenguang Pharmaceutical Co., Ltd., Guangzhou Tianjin Health Pharmaceutical Co., Ltd and Guangzhou nanbeihang decoction pieces Co., Ltd The author found that the three certificates are all GMP certificates of Chinese herbal pieces From the point of view of [main problems found in the inspection], the serious defects are mainly concentrated in the following aspects: untrue production records, lack of batch production records of Chinese herbal pieces, lack of inspection records of Chinese herbal medicine and Chinese herbal pieces, etc Table 1: on November 22-23, 3 GMP certificates were withdrawn, and on November 22 and 23, 48 GSP certificates were withdrawn / revoked in Chongqing, Panjin and Linyi The number of GSP certificates was also rare before, as shown in Table 2 Table 2: 48 GSP certificates withdrawn / revoked on November 22-23