中药国际注册作为国际化的重要标志，是中医药被世界主流医学认可，进入国外医药市场的关键环节。目前仅有5个中药产品获得欧盟成员国传统应用注册批准，其中逍遥片是首个在欧盟成员国注册的复方中药。如何基于传统应用证据充分证明产品的安全性，是复方中药在传统应用注册过程中的难点。根据逍遥片的注册经验，总结欧盟法规对草药产品传统应用证据评价要求，论述从传统应用、非临床和临床对复方中药产品的安全性评估，为中药欧盟注册提供借鉴和参考，助力优秀中药品种进入欧盟市场，共同推动中药国际化进程。

As an important symbol of internationalization, the international registration of traditional Chinese medicine (TCM) is a key link for Chinese medicine to be recognized by mainstream medicine around the world and enter the foreign pharmaceutical market. Currently, only five TCM products have so far been successfully registered in the European Union as traditional herbal medicinal products (THMPs). Xiaoyao Tablets (逍遥片) is the first compound THMP from China to be successfully registered in European Union. A challenging point in the traditional use registration (TUR) is the safety justification of proposed products on account of traditional use. Based on Xiaoyao Tablets' register experience, this paper summarizes the requirements of European Union guidelines on the traditional use evidence. Moreover, it also discusses the safety evaluation of compound THMPs from traditional use, non-clinical, and clinical perspective. It is anticipated that this paper will serve as a reference for the European Union registration of TCM, help excellent TCM varieties enter the EU market and jointly promote the globalization of TCM.

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科技部“重大新药创制”重大专项资助项目（2018ZX09303024）