Week Jun: 59 pharmaceutical companies lost GMP / GSP certificate!

The 12th Five Year Plan for national drug safety puts forward five planning indicators for drug safety management: (1) all chemical and biological product standards meet or are close to international standards, and Chinese medicine standards lead the development of international standards More than 90% of medical devices adopt international standards (2) Among the generic drugs approved for production before the implementation of the measures for the administration of drug registration revised in 2007, the quality of national essential drugs and commonly used clinical drugs has reached the international advanced level (3) 100% of the drug production meets the requirements of the drug production quality management specification revised in 2010; 100% of the sterile and implantable medical device production meets the requirements of the medical device production quality management specification (4) 100% of the drug distribution meets the requirements of the drug distribution quality management standard (5) All new retail pharmacies are equipped with licensed pharmacists In 2015, all retail pharmacies and hospital pharmacies realized their business with licensed pharmacists to guide rational drug use This year is the first year of the 13th five year plan It is an inevitable trend for the State Food and drug administration to strictly supervise the production, operation and use of drugs On August 11, the State Food and Drug Administration issued the announcement on the verification of drug production process (Draft for comments), requiring drug manufacturers to carry out self inspection on the production process of each approved listed drug (traditional Chinese medicine is the manufacturing method) from the date of the announcement, so as to eliminate the hidden danger of quality and safety Pharmaceutical enterprises shall complete self inspection and report the situation of self inspection before October 1, 2016; CFDA will organize experts to carry out flight inspection on pharmaceutical manufacturers from November 1, 2016 Under the strategy of self inspection and flight inspection, GMP and GSP certificates are withdrawn / revoked more and more frequently, including well-known pharmaceutical industry According to incomplete statistics of Xiaobian, 22 pharmaceutical companies lost GMP certificates this week (August 8-august 13), and 37 pharmaceutical companies lost GSP certificates Table 1: GMP certificate withdrawn / cancelled (failed to pass the new GMP certification) in this week (August 8-august 13): Table 2: GSP certificate withdrawn / cancelled in this week (August 8-august 13):