There are new changes in GMP and GSP certification, which are listed in the reserved catalogue

[industry trends of pharmaceutical network] on September 17, the State Food and Drug Administration issued the public consultation of the comprehensive Department of the State Food and Drug Administration (hereinafter referred to as "opinions") The catalogue shows that it is planned to keep 105 certificates, such as business license, pharmaceutical production license, pharmaceutical trading license, pharmaceutical production quality management standard certificate, pharmaceutical trading quality management standard certificate and inspection report Industry insiders said that once the draft was approved, it means that GMP and GSP are suspended In a word, GMP and GSP certification will continue to be independent administrative acts and issue corresponding certificates As soon as the news came out, everyone was surprised that the GMP and GSP certification had been cancelled before? On August 26, 2019, after the new revision of the drug administration law was voted through, the revised Drug Administration Law has 12 chapters and 155 articles in total, among which one article confirms to cancel the GMP / GSP certification and issuance, and will be inspected together with the drug production license and business license in the future, and the relevant departments can inspect the implementation of GMP / GSP at any time Since the newly revised National Drug Administration Law has deleted the relevant description, why does it appear in the list to be retained? First, look at the opinions According to the requirements of the catalogue, it will be related to the drug safety of the masses It is really necessary in the process of administrative licensing, administrative confirmation and administrative payment At present, it is not possible to achieve a comprehensive and effective information sharing verification of the certification matters, which are listed in the catalogue Obviously, GMP and GSP play an important role in administrative management, and the conditions for cancellation are not sufficient To keep GMP and GSP is conducive to the government's supervision of the industry But at the same time, the opinion also said that dynamic management will be implemented, and with the continuous improvement of the legal system and the continuous improvement of the level of information technology, timely adjustments will be made to the certification matters Local governments are encouraged to explore in advance, and drug regulatory departments of all provinces, autonomous regions and municipalities directly under the central government can combine their own reality On the premise that conditions are met, relevant certification matters will be cancelled gradually, and GMP and GSP certification may be cancelled However, no matter whether GSP and GMP certification are cancelled or not, strengthening post market supervision is a certainty In fact, the national regulation has become more and more strict in recent years From time to time, we can hear which enterprise has been withdrawn from GSP or GMP certification In April, four pharmaceutical enterprises including Heilongjiang Xiangtai decoction pieces Co., Ltd were withdrawn their GMP certificate in accordance with the provisions of Article 33 of the measures for the administration of the certification of pharmaceutical production quality management specifications due to their serious violation of the provisions of the pharmaceutical production quality management specifications In the same month, Nanning Jingchang traditional Chinese medicine decoction pieces Co., Ltd seriously violated the provisions of the "drug production quality management specification" in the special inspection of centralized quality control of traditional Chinese medicine decoction pieces According to the provisions of Article 55 of the measures for the supervision and administration of drug production and Article 33 of the measures for the administration of the standardization and certification of drug production quality management, its GMP certificate has been withdrawn according to law Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd and Tianjin Baite medical supplies Co., Ltd also received GMP certificates In August, Hubei Huanggang Yinhe ADI Pharmaceutical Co., Ltd seriously violated the provisions of the "drug production quality management specifications", and according to the provisions of Article 33 of the "management measures for the certification of the" drug production quality management specifications ", the drug regulatory authority withdrew its" GMP certificate "in accordance with the law There are data statistics in the industry In 2018, the State Food and Drug Administration organized and reported 37 drug flight inspections, an increase of 8 compared with 29 in 2017, and the strength of 2019 flight inspection is still strengthening Under the background of dynamic flight inspection, pharmaceutical enterprises will face more strict supervision, and should not be careless in drug development, production, operation and use activities.