- http://subsites.chinadaily.com.cn/nmpa/aboutNMPA.html
- http://subsites.chinadaily.com.cn/nmpa/2019-07/18/c_377587.htm
- http://subsites.chinadaily.com.cn/nmpa/2019-07/18/c_380718.htm
National Institutes for Food and Drug Control (Center for Medical Device Standards Management of NMPA, National Institute for Drug Control)
Main responsibilities
(1) Undertake the sampling and testing of food, drugs, medical devices, cosmetics and related pharmaceutical excipients, packaging materials and containers (hereinafter referred to as food and drugs). Organize the sampling and testing, and quality analysis of drugs, medical devices and cosmetics. Be responsible for relevant re-evaluation and technical arbitration. Organize the pre-approval testing of imported drugs, and the collection and analysis of relevant post-market data.
(2) Undertake the formulation, revision and technical review of quality standards, technical specifications, technical requirements, and sampling and testing methods for drugs, medical devices and cosmetics. Organize and carry out research on new technologies, methods and standards for sampling and testing. Undertake the experimental research on the cause of serious adverse reactions and serious adverse events of relevant products.
(3) Be responsible for the management of medical device standards.
(4) Undertake the lot release of biological products.
(5) Undertake the technical evaluation of cosmetics safety.
(6) Organize the planning, research, preparation, standardization, distribution and management of national reference materials.
(7) Be responsible for the verification of bacterial and viral strains and cell strains used for production. Undertake the collection, identification, preservation, distribution and management of medical standard bacterial and viral strains and cell strains.
(8) Take charge of the rearing, breed conservation, supply of experimental animals, and the quality testing of experimental animals and relevant products.
(9) Undertake the inter-laboratory comparison, proficiency testing, assessment and evaluation on food and drug testing institutions.
(10) Be responsible for postgraduate education and training. Organize and carry out training and technical guidance on the quality sampling and testing for relevant food and drug institutions.
(11) Carry out international (regional) exchange and cooperation in food and drugs sampling and testing.
(12) Complete other tasks assigned by NMPA.