Regulation of Traditional Chinese Medicine Drugs: Efficacy and Safety.

Regulatory documents on requirements for TCM drug registration are officially issued, which are divided into 4 levels: Act, Rules, Regulation and Guidance. With the above-mentioned regulations, a two-phase (IND/NDA) and two-level evaluation y (provincial and estate). for TCM drug registration for marketing is required, The requirements for R & D and production of TCM drugs are standardized based on internationally-acceptable standards, such as GLP, GCP, GMP and so on, In order to apply for the registration, 4 parts of dossiers should be submitted to SFDA (State Food & Drug Administration in China): Part I: Description and review on the TCM drugs Part II: CMC data; Parl III: Pharmacology and toxicology data; and Part IV: Clinical study data. In Part III, there is a list of toxicological research works required for TCM drug registration for marketing. The requirements including toxicological works differ with different category's TCM drug in preclinical as well as clinical studies, In addition, considerations on TCM's safe use are described in details. Finally, progress in post-market surveillance of adverse reactions of TCM drugs in China is briefly discussed.