GMP is a set of mandatory standards applicable to pharmaceutical and food industries, which requires enterprises to meet the hygiene and quality requirements in raw materials, personnel, facilities and equipment, production technology, packaging and transportation, and quality control. , and form a set of operating norms to help enterprises improve the sanitary environment, timely find the problems existing in the production process and improve them. In short, GMP requires pharmaceutical, food and other production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the final product quality (including food safety and hygiene) meets the requirements of laws and regulations.
The Ministry of Health of China issued the Notice of Wei Yaofa (1995) No.35 on Developing GMP Certification on July1995. Drug GMP certification is a system that the state implements GMP supervision and inspection on drug production enterprises (workshops) and drug varieties according to law and obtains recognition. Although the international drug concept includes veterinary drugs, only a few countries, such as China and Australia, separate GMP for human use from GMP for veterinary drugs.
Drug GMP certification is divided into national and provincial levels. According to the "Regulations on the Implementation of the Drug Administration Law of People's Republic of China (PRC)", the pharmaceutical supervisory and administrative departments of the people's governments at or above the provincial level shall organize the certification of pharmaceutical production enterprises in accordance with the implementation measures and steps stipulated by the good manufacturing practice and the pharmaceutical supervisory and administrative departments of the State Council. In line with the "good manufacturing practice", issued a certificate of certification. Among them, the certification of pharmaceutical production enterprises that produce injections, radioactive drugs and biological products as stipulated by the drug supervision and administration department of the State Council is the responsibility of the drug supervision and administration department of the State Council.
Legal analysis: EU GMP certificate is the gateway to the European market, without which it cannot be sold in the EU. The EU is now recognized as one of the most important international drug markets. As the results of GMP inspection are mutually recognized by EU member states and shared with Japan, Australia, the United States and Canada, the influence of EU GMP certification is growing worldwide.
Legal basis: People's Republic of China (PRC) Foreign Trade Law.
Article 5 People's Republic of China (PRC) shall, on the basis of equality and mutual benefit, promote and develop trade relations with other countries and regions, conclude or join regional economic and trade agreements such as customs union agreements and free trade zone agreements, and participate in regional economic organizations.
Article 6 In terms of foreign trade, People's Republic of China (PRC) grants MFN treatment and national treatment to other contracting parties and participants in accordance with international treaties and agreements it has concluded or acceded to, or grants MFN treatment and national treatment to each other in accordance with the principle of reciprocity and reciprocity.