Many certificates of traditional Chinese medicine enterprises have been collected, and only when they are in compliance with the regulations can they stand firm

[trends of pharmaceutical network industry] in recent years, with the strengthening of drug flight inspection, there has been news that GMP certificates have been taken away from various places, among which the frequency of Chinese herbal medicine enterprises being taken away is more frequent The author combed the situation of GMP certificates being taken away by local enterprises since July Heilongjiang: two enterprises have recently announced that they have seriously violated the provisions of the "drug production quality management specification" and decided to withdraw their "GMP certificate" in accordance with the provisions of Article 33 of the "drug production quality management specification certification management measures" The recovery scope of these two enterprises is Chinese herbal pieces Anhui: on July 9-10, 2019, according to the clue of report, Anhui Provincial Bureau conducted a flight inspection on a Chinese herbal medicine decoction piece enterprise in Anhui Province, and found that the enterprise had seriously violated the "drug production quality management specification" In accordance with the provisions of Article 33 of the measures for the administration of GMP certification, it is decided to withdraw the GMP certificate of the enterprise according to law Shandong: in the middle of February, the market supervision and Administration Bureau of Shandong Province issued the notice of withdrawal of GMP certificate No 3 in 2019, in which one Chinese herbal medicine enterprise was seriously in violation of the regulations and was withdrawn the GMP certificate Chongqing: on August 2, Chongqing food and Drug Administration announced to cancel the drug production license and GMP certificate of a Chinese herbal medicine enterprise due to the revocation of the drug production license Jilin: on August 5, Jilin food and Drug Administration announced that a Chinese herbal medicine decoction piece enterprise seriously violated the provisions of the pharmaceutical production quality management standard, and decided to withdraw its GMP certificate according to the provisions of Article 33 of the pharmaceutical production quality management standard certification management measures, which is hereby announced Hubei: on July 5, a company issued the notice of No 16, 2019 to withdraw the GMP certificate of a traditional Chinese medicine enterprise in Hubei Province According to the industry, Chinese medicine manufacturers are the top priority of the flight inspection of the drug administration Due to the high cost of pharmaceutical enterprises for producing drugs in strict accordance with GMP requirements, many pharmaceutical enterprises do not pay attention to production and management issues, and the certificate will be taken away once the flight inspection "In recent years, the intensive means of supervision and the expansion of flight inspection personnel have left most pharmaceutical enterprises defenseless, and many small and medium-sized enterprises even face the choice of life and death." According to the report of the State Food and drug administration, among the 57 flight inspections carried out in 2017, the high proportion was the traditional Chinese medicine preparation manufacturers, accounting for 49% of the total flight inspection work, while the proportion of traditional Chinese medicine Pieces accounted for about 12%, which has been increasing since 2018 From the current data of flight inspection, the situation is not optimistic In view of the situation that the GMP certificate of the company has been withdrawn, the industry said that the company can reapply the GMP certificate after the investigation results and rectification However, re application for GMP certificate is short for one or two months and long for half a year In general, with the coming of special inspection, flight inspection and other forms of supervision and inspection, as well as the growing strength of the national drug inspection team, drug companies will bear more and more pressure to receive GMP in flight inspection In addition, driven by complaints and reports, pharmaceutical enterprises can only stand firm in the storm of flight inspection by strengthening compliance production This is also conducive to the upgrading of the pharmaceutical industry and improving the quality and safety of drugs.