Current Status and Future Perspective in the Globalization of Traditional Chinese Medicines

Abstract

Globalization of traditional Chinese medicines started around 1996, which was initiated by the Chinese government. However, substantial progress was only achieved in recent years including the adoption of TCM quality monographs in the western pharmacopoeias (United States Pharmacopoeia and European Pharmacopoeia) and registration in main stream drug regulatory agencies such as US Food and Drug Administration (FDA) and European Medicines Agency (EMA). So far, several TCM herbal quality monographs were adopted by the United States Pharmacopoeia including Chinese Salvia, Ganoderma lucidum and Panax notoginseng, etc. Over 45 TCM quality monographs were recorded in the European Pharmacopoeia with 20 more in progress. After the successful registration of the first TCM product named Diao Xin Xue Kang as traditional medicine via the Medicines Evaluation Board of the Netherlands, several other TCM herbal products are in the registration process in several European member states. So far, there has been still not any TCM product authorized as a drug by the FDA regardless of a few TCM products in phase III or phase II clinical trials. This review summarizes the progress made in the globalization of traditional Chinese medicines in recent years and future issues in this regard.

Keywords

• Globalization
• Traditional Chinese Medicine (TCM)
• Quality Monograph
• Registration regulation