Herbal medicine played an important role during the development of human history as a way to cure and prevent diseases and has longer history than chemical drugs and biological products. Herbal medicine has different definitions and different scopes in different countries. It is usually called botanical drug product in the USA and herbal medicinal product in the EU. In China, it is usually called traditional Chinese medicine (TCM).
KeywordsTraditional Chinese Medicine Herbal Medicine Herbal Medicinal Product Initial Clinical Study Botanical Drug
Drs. Mo Dan and Hairu Wen critically read the paper and helped in language translation.
References and Further Reading
- Dietary Supplement Health and Education Act. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/ucm148003.html
- Provisions for Drug Registration, CFDA. http://www.sfda.gov.cn/WS01/CL0053/24529.html
- Q&A: Registration of Traditional Herbal Medicinal Products, EMA. http://ec.europa.eu/dgs/health_consumer/docs/traditional_herbal_medicinal_products_en.pdf
- U.S. Food and Drug Administration. Federal food, drug, and cosmetic act. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm
- U.S. Food and Drug Administration. Guidance for industry: botanical drug products [EB/OL]. http://www.fda.gov/cder/Guidance/4592fnl.ht. 11 Feb 2004