Department of Drug Registration (Department of TCMs and Ethno-Medicines Regulation)
To organize the formulation and supervise the implementation of the Chinese Pharmacopoeia and other drug standards as well as technical guidance, and to formulate and implement the drug registration system; to supervise the implementation of good practices for drug non-clinical studies and clinical trials and processing specification for TCM decoction pieces, and implement the TCM products protection system; to organize the implementation of the classification management system, inspect the R&D sites and investigate and punish relevant illegal acts; to participate in the development of the National Essential Drug List, and to cooperate in the implementation of the national essential drug system.
1) Division of General Affairs (Office of Drug Regulation Reform)
2) Division of Drug Research
3) Division of Traditional Chinese Medicines and Ethno-Medicines
4) Division of Chemical Drugs
5) Division of Biological Products