Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas ISSN: 0717-7917
[email protected] Universidad de Santiago de Chile Chile WANG, Ping; ZUGUANG, Ye Regulation of Traditional Chinese Medicine Drugs: Efficacy and Safety Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas, vol. 8, núm. 1, 2009, pp. 17-23 Universidad de Santiago de Chile Santiago, Chile Available in: http://www.redalyc.org/articulo.oa?id=85680105 How to cite Complete issue Scientific Information System More information about this article Network of Scientific Journals from Latin America, the Caribbean, Spain and Portugal Journal's homepage in redalyc.org Non-profit academic project, developed under the open access initiative Numero Especial: Regulación de Fitomedicamentos II | Special Issue: Regulation of Phytomedicines II © 2009 Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas, 8 (1), 17 - 23 BLACPMA ISSN 0717 7917 Review | Revisión Regulation of Traditional Chinese Medicine Drugs: Efficacy and Safety. [Regulación de Medicinas Tradicionales Chinas: eficacia y seguridad] Ping WANG 1 and Ye ZUGUANG 2 1. The State. Food & Drug Administration Chinese Pharmacopeia Commission, Beijing, People's Republic of China. 2. China Academy of Chinese Medical Sciences, National Research Centre for R & D of Multi-ingredients TCM Products, Beijing 100700 People's Republic of China. Abstract 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.