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 ......