China Food and Drug Inspection and Research Institute is directly affiliated to the US Food and Drug Administration. It is the legal institution and the highest technical arbitration institution for the quality inspection of pharmaceutical biological products. To undertake the examination and approval, registration inspection, import inspection, supervision inspection, safety evaluation and batch issuance of biological products in the fields of drugs, biological products, medical devices, food, health food, cosmetics, experimental animals and packaging materials according to law, and be responsible for the research of national standard materials for drugs and medical devices and bacteria and viruses for production inspection.
The former Institute of Traditional Chinese Medicine was the Institute of Drug and Food Inspection and the Institute of Biological Products Inspection of the Ministry of Health of the Central People's Government established in 1950. 196 1, and the two institutes were merged into the Institute for the Control of Pharmaceutical and Biological Products of the Ministry of Health. From 65438 to 0998, from the Ministry of Health to institutions directly under the State Administration of Pharmaceutical Products.
The main responsibilities of China Food and Drug Inspection and Research Institute:
1. Undertake the registration and approval of drugs and medical devices and their technical review, undertake the inspection and test required for the approval of health food and cosmetics, and be responsible for the registration and inspection of imported drugs and the review of their quality standards.
2. To undertake the supervision and inspection, entrusted inspection, spot check inspection and safety evaluation inspection related to the food safety of drugs, medical devices, health foods, cosmetics and catering services, and be responsible for the inspection of drug import ports.
3. To undertake the revision of food safety-related standards, technical specifications and requirements and inspection methods for drugs, medical devices and catering services, and the technical review and verification of the revision of technical specifications, technical requirements and inspection methods for health foods and cosmetics.
4. To undertake the registration inspection, supervision inspection, entrusted inspection, re-inspection and technical verification of pharmaceutical excipients, packaging materials and containers in direct contact with drugs, as well as the technical review and verification of the revision of relevant national standards.