中药产品属于加拿大传统药物的范畴，可以通过传统药物声明的申请途径取得加拿大天然健康产品许可证。构建资质证据材料体系，从传统药物申请途径的适用性、传统药物的安全性和有效性3个方面评价药品，并提出一种证据评估模板，帮助申请人准备符合标准的证据，推动中药国际化注册进展，为我国完善药品注册体系提供参考。

Traditional Chinese medicine prescription is belonged to Canadian natural health products, and it can obtain the Canadian Natural Health Product License by the traditional medicine's claims. This article constructs a qualification evidence material system to evaluate drugs from three aspects:the applicability of traditional drug application channels, the safety and effectiveness of traditional drugs, and proposes an evidence assessment template to help applicants prepare evidence that meets the standards, promote the internationalization of traditional Chinese medicine registration, and provide reference for improving China's drug registration system.

R288.1

国家重点研发计划项目（2017YFC1703700）