GMP means that the pharmaceutical factory is standardized, while patent medicine means that the drug is new
Both of them have nothing to do with the legality and effectiveness of the drug
gmp" is The abbreviation of good manufacturing practice in English means "good working practice" or "good manufacturing standards" in Chinese. It is an independent management system that pays special attention to product quality and health and safety in the manufacturing process. It is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires enterprises to meet hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control, etc., and form an operational set of standards. The operating specifications help companies improve their hygienic environment and promptly identify problems in the production process and improve them.
With the development of GMP, pharmaceutical GMP certification has been implemented internationally. GMP provides basic guidelines for drug production and quality management. Drug production must meet the requirements of GMP, and drug quality must meet legal standards. On July 11, 1995, the Ministry of Health of the People's Republic of my country issued the "Notice on Carrying out the GMP Certification of Drugs" issued by the Ministry of Health (1995) No. 35. Drug GMP certification is a system for the state to implement GMP supervision and inspection on drug production enterprises (workshops) and drug varieties in accordance with the law and obtain approval. It is an important part of international drug trade and drug supervision and management, and also ensures drug quality stability, safety and Effectiveness is a scientific and advanced management method. In the same year, the china certification committee for drugs (cccd) was established. After the establishment of the State Drug Administration in 1998, the State Drug Administration Drug Certification Management Center was established. Starting from July 1, 1998, the Ministry of Health will not accept applications for the production of new drugs for enterprises that have not obtained drug GMP certification. If a new drug is approved, only a new drug certificate will be issued, but no drug approval number will be issued. Strictly review and approve newly established pharmaceutical manufacturing enterprises. Those who have not obtained a pharmaceutical GMP certification shall not be issued a "Drug Manufacturing Enterprise License".
For enterprises (workshops) that have obtained drug GMP certification, when applying for the production of new drugs, the drug regulatory department will give priority to those enterprises (workshops) that have not obtained drug GMP certification as of June 30, 1998. , the drug regulatory authorities will no longer accept applications for new drug production. Drugs that have obtained drug GMP certification certificates can apply to the State Council's drug regulatory department for certificates of drug export sales when participating in international drug trade: and can re-apply to the price department for verification of the price of the drug in accordance with national regulations on drug price management. . Drug business units and medical units at all levels must give priority to purchasing and using drugs that have obtained drug GMP certification certificates and drugs produced by enterprises (workshops) that have obtained drug GMP certification certificates. Drugs certified by GMP can use the certification mark on corresponding drug advertising, drug packaging and labels, and instructions.
Food GMP certification was initiated by the United States in the 1960s. Currently, in addition to the United States, which has legislated to enforce food GMP, other countries such as Japan, Canada, Singapore, Germany, Australia, China, etc. still adopt persuasive methods to provide guidance to the industry. Automatic and spontaneous implementation.