Traditional Chinese medicine (TCM) is a valuable resource for the Chinese nation. With its rich theoretical foundation and long-term practical experience, it provides a solid foundation and rich source for various types of pharmaceutical innovation. The European Union (EU) established Committee on Herbal Medicinal Products (HMPC) and issued 2004/24/EC Directive and 2001/83/ EC Directive, which provides legal protection for strengthening the management of traditional medicines and unifying the drug registration standards of member states. It also provides the possibility for Chinese herbal medicine, a precious medical resource, to enter the European market and benefit European citizens. However, in the application process by Chinese traditional medicine manufacturers, there are practical problems such as unclear mechanism of action and differences in drug quality requirements between China and EU. By selecting an appropriate application direction and strategy, the type of drug applied is inclined to the direction of simpler drugs with a simpler mechanism of action. Meanwhile, the policy advantages of local drug manufacturers should be fully taken to strengthen bilateral or multilateral cooperation and other ways to deal with it, providing the possibility to promote the traditional Chinese herbal medicine to go abroad, better serve the people of all countries, and promote the international development of TCM.

ZHOU A-jian;QIU Le;LU Feng-jiao;YE Zu-guang

Beijing Jiayi Language Service Co.,Ltd.Beijing 100029,China;Institute for History of Medicine and Medical Literature,China Academy of Chinese Medical Sciences,Beijing 100007,China;School of Humanities,Beijing University of Chinese Medicine,Beijing 100029,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100007,China

世界中西医结合杂志（英文）

[1]ZHOU A-jian;QIU Le;LU Feng-jiao;YE Zu-guang-.Discussion on the Chinese Materia Medica Under EU Regulations for Traditional Herbal Medicines)[J].世界中西医结合杂志（英文）,2022(03):37-45

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