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(qǐng)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(qǐng)途徑的適用性、傳統(tǒng)藥物的安全性和有效性3個(gè)方面評(píng)價(jià)藥品，并提出一種證據(jù)評(píng)估模板，幫助申請(qǐng)人準(zhǔn)備符合標(biāo)準(zhǔn)的證據(jù)，推動(dòng)中藥國際化注冊(cè)進(jìn)展，為我國完善藥品注冊(cè)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(diǎn)研發(fā)計(jì)劃項(xiàng)目（2017YFC1703700）