王硕 孟凡英 周瑛桃

摘要 中医药是我国独特的卫生资源，潜力巨大的经济资源，具有原创优势的科技资源、優秀的文化资源和重要的生态资源。随着“一带一路”战略提出，国际社会对中医药的需求日益扩大，中药国际化进程在逐渐加快。但中药海外注册形势依然严峻，文化差异显著、科技内涵不足、法规标准滞后、技术贸易壁垒等因素，给中药产品海外注册造成了很大障碍。通过对我国中药产品海外注册现状进行分析，了解和掌握中药产品海外注册存在的问题，并针对性地提出策略和建议，为探索中药产品国际化路径与模式提供依据和参考。

关键词 一带一路;中药产品;海外注册;中药出口;文化差异;科技内涵;法规标准;贸易壁垒

Abstract Traditional Chinese medicine（TCM）is China′s unique health resources，economic resources with great potential，scientific and technological resources with original advantages，excellent cultural resources and important ecological resources.With the Belt and Road Initiative Strategy proposed，the international community′s demand for TCM is expanding，and the process of internationalization of Chinese medicinal is gradually accelerating.However，the overseas registration situation of Chinese Medicinal is still grim，with significant cultural differences，insufficient scientific and technological connotation，lagging regulatory standards，and technical trade barriers，which have caused great obstacles to the overseas registration of Chinese medicinal products.This paper analyzes the status of overseas registration of Chinese medicinal products，understands and masters the problems of overseas registration of Chinese medicinal products，and proposes strategies and suggestions in a targeted manner to provide basis and reference for exploring the internationalization path and mode of Chinese medicinal products.

Keywords Belt and Road Initiative; Chinese medicinal products; Overseas Registration; Chinese medicinal export; Cultural differences; Technological connotation; Regulations and standards; Trade barriers

中图分类号：R2-03文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.09.029

中医药是我国独特的卫生资源，潜力巨大的经济资源，具有原创优势的科技资源，优秀的文化资源和重要的生态资源，在经济社会发展全局中意义重大。党的十九大报告提出实施健康中国战略，坚持中西医并重，传承发展中医药事业。习近平总书记指出，加快推进中医药现代化、产业化，让中医药走向世界。党中央、国务院印发《关于促进中医药传承创新发展的意见》，进一步促进中医药传承与开放创新发展。

“一带一路”已成为当今世界规模最大的国际合作平台，中国已同136个国家和30个国际组织签署195份合作协议，共建“一带一路”国家已由亚欧延伸至非洲、拉美、南太、西欧等相关国家[1]。……