中藥產(chǎn)品屬于加拿大傳統(tǒng)藥物的范疇，可以通過傳統(tǒng)藥物聲明的申請途徑取得加拿大天然健康產(chǎn)品許可證。構(gòu)建資質(zhì)證據(jù)材料體系，從傳統(tǒng)藥物申請途徑的適用性、傳統(tǒng)藥物的安全性和有效性3個方面評價藥品，并提出一種證據(jù)評估模板，幫助申請人準備符合標準的證據(jù)，推動中藥國際化注冊進展，為我國完善藥品注冊體系提供參考。

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

國家重點研發(fā)計劃項目（2017YFC1703700）