After Zhejiang, another large province issued the notice of GMP / GSP certification stopping

[industry trends of pharmaceutical network] on October 25, Hebei Drug Administration issued a notice on issues related to the certification of quality management standards for drug production and operation According to the announcement, from December 1, 2019, the application for certification of pharmaceutical production quality management specifications and pharmaceutical trading quality management specifications will not be accepted If the validity of the certificate expires before June 1, 2020, and the applicant intends to continue to apply for the certification of drug production quality management specifications and drug distribution quality management specifications, the application for certification shall be submitted before December 1, 2019 In addition to Hebei, Zhejiang drug administration also issued the announcement on matters related to GMP / GSP certification on October 8, saying that it will not accept matters related to GMP and GSP certification since December 1, 2019 For the pharmaceutical manufacturers that have obtained the GMP certificate, if the validity of the certificate is after June 1, 2020, Zhejiang food and Drug Administration will no longer accept the GMP certification related matters from October 20, 2019 The successive cancellation of GMP / GSP certification in two major pharmaceutical provinces is actually originated from the newly revised Drug Administration Law of the people's Republic of China (hereinafter referred to as the "Drug Administration Law") in August, and it is determined that the cancellation of GMP and GSP certification will be implemented from December 1 Since the drug administration law was promulgated in 1984, it was revised in February 2001 In addition to the revision of individual provisions in December 2013 and April 2015 due to the reform of "release management service", this is a comprehensive revision 18 years later According to the drug administration law, GMP certification in China can be traced back to 1998 In addition, the GSP for drug trading enterprises also began to implement compulsory certification The quality standard certification in the field of drug production and operation has played a very important role in improving the standardization level of local drug manufacturers and eliminating backward production capacity for quite a long time However, with the development of the times and the improvement of the market mechanism, the regulatory authorities gradually realize that GMP, GSP, etc are actually standard standards, not strict requirements, and this kind of supervision mode which emphasizes the prior approval blindly can not achieve the purpose of ensuring the safety of the masses The cancellation of GMP and GSP certification and the establishment of a regulatory model covering the whole process and life cycle will be put on the agenda and will be officially implemented from December 1 So, will the cancellation of GMP / GSP certification in the drug administration law reduce the regulatory standards for pharmaceutical enterprises? Some insiders said that after the cancellation of GMP / GSP certification, it is possible to reduce the time cost of relevant enterprises in declaration, but in the long run, it will not reduce the audit standard for the industry In recent years, the state has continuously strengthened flight inspection, refined the division of responsibilities of the national and provincial drug administrations, gradually replaced the certification supervision by daily supervision, and the significance of GMP certification has been weakened Now, the cancellation of GMP / GSP certification means that how to comply with safety regulations will become a matter for pharmaceutical enterprises in the future In addition, even if the GMP / GSP certification is cancelled, there are still many measures affecting drug companies in the revision of the new drug management law, such as the system of multiple listing license holders, drug traceability and so on Once there is a problem in drug quality, the punishment will be more severe As long as the enterprise runs for one day, the national inspection of safety supervision will not stop for one day Even if you just passed the on-site inspection today, it does not mean that you will not be punished by the regulatory authorities tomorrow The safety of drug use by the masses is more important than that of Mount Tai, and the drug supervision will not let go but be stricter The cancellation of GMP / GSP certification means more, stricter and scientific supervision rather than relaxation for the industry.