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| Current Status and Future Perspective in the Globalization Of Traditional Chinese Medicines |
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| DOI：10.15806/j.issn.2311-8571.2014.0027 |
| KeyWord:Globalization Traditional Chinese Medicine (TCM) Quality Monograph Registration regulation |
| Author | Institution |
| Wan-Ying Wu |
Institute of Materia Medica, Chinese Academy of Sciences, Shanghai , China, Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai |
| Wen-Zhi Yang |
Institute of Materia Medica, Chinese Academy of Sciences, Shanghai , China, Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai |
| Jin-Jun Hou |
Institute of Materia Medica, Chinese Academy of Sciences, Shanghai , China, Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai |
| De-An Guo* |
Institute of Materia Medica, Chinese Academy of Sciences, Shanghai , China, Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai |
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| Abstract: |
| Globalization of traditional Chinese medicines started around the 1996, which was initiated by the Chinese government. However, some 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 China Salvia, Ganoderma lucidum and Panax notoginseng, etc. Over 45 TCM quality monographs were recorded in the European Pharmacopoeia with 20 more in the progress. After the successful registration of the first TCM product named Di Ao Xin Xue Kang as traditional medicine in 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 no any TCM product registered as a drug in FDA despite of a few products in phase III or phase II clinical trials. This review summarized the progress made in the globalization of traditional Chinese medicines in the recent years and the future issues in this regard were also projected. |
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