中药作为我国古代科学的瑰宝，被越来越多的国家和机构认可，中药“走出去”的步伐不断加快。加拿大作为具有多元文化的移民国家，对传统医药文化包容度高，传统医药市场成熟，对我国中药有较高的接受程度和广泛应用。2004年1月1日颁布实施的《天然药品管理办法》标志中国传统中药以天然药品身份依法纳入加拿大药品注册监管。基于加拿大现有的天然药品监管体系，结合注册实践，总结加拿大卫生部对于天然药品的注册申请要求及审评关注点，分析我国不同类型的中药产品如何以最合适的申报路径进入加拿大市场，以期为传统中药的国际化提供借鉴和参考，推动中药国际化的进一步发展。

As the treasure of ancient science, traditional Chinese medicine (TCM) has been accepted by more and more countries and institutions, and the pace of “going overseas” is accelerating. As a multicultural immigrant country, Canada has a high tolerance for traditional medicine culture, a mature traditional medicine market, and a high acceptance and wide usage of TCM. With the implementation of “Natural Health Products Regulations, NHPR” on January 1, 2004, the TCM as incorporated into the Canadian drug registration and supervision system as Natural Health Products (NHPs). Based on the regulatory system of NHPs in Canada, combined with application practice, this paper summarizes the application requirements and review concerns of Health Canada for the registration of NHPs, analyzes how different types of TCM enter the Canadian market with the most appropriate application path, providing reference and promoting the further development for the internationalization of TCM.

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国家重点研发计划资助项目（2024YFC3507301）； 2024 年药品监管科学全国重点实验室第二批课题（2024SKLDRS0221）