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目的:以姜黄为例解析《欧盟传统草药专论》,为中药建立欧盟传统草药专论(CHM)提供参考。方法:以姜黄为实例对欧盟传统草药专论进行研究,深入解析其建立程序及相关重要文件,从实证研究角度明确欧盟草药专论的建立流程与评价关键。结果:《欧盟传统草药专论》在中药有效性与安全性评价以及中药产品欧盟注册中发挥着极其重要的作用。结论:建议由我国政府相关行业主管部门牵头相关单位协助,结合国内研究基础以及厂家申报注册所涉及具体中药品种情况,与欧洲药品局(EMA)展开类似交流合作,及早建立相当数量的中药CHM,助力中药产品欧盟注册,推动中药标准化和国际化进程。
Objective: To analyze the “Monograph of Traditional Herbal Medicine in the EU” with the example of turmeric, and provide reference for the establishment of traditional Chinese herbal medicine (TCM) monograph on traditional Chinese herbal medicine (CHM). Methods: Taking Turmeric as an example, the EU traditional herbal monographs were studied, and its establishment procedures and related important documents were analyzed in depth. The key points of the establishment process and evaluation of EU herbal monographs were clarified from the perspective of empirical study. Results: The “EU monograph on traditional herbs” plays an extremely important role in the evaluation of the effectiveness and safety of traditional Chinese medicines and the registration of Chinese medicine products in the EU. Conclusion: It is suggested that China government should take the lead of relevant departments in charge of relevant industries to assist in the development of similar exchanges and cooperation with the European Medicines Agency (EMA) based on the domestic research basis and the specific varieties of Chinese medicines involved in the declaration of manufacturers. Early establishment of a considerable number of Chinese herbal medicines such as CHM, Help the registration of traditional Chinese medicine products EU to promote the standardization and internationalization of traditional Chinese medicine.