中藥作為我國古代科學(xué)的瑰寶，被越來越多的國家和機(jī)構(gòu)認(rèn)可，中藥“走出去”的步伐不斷加快。加拿大作為具有多元文化的移民國家，對傳統(tǒng)醫(yī)藥文化包容度高，傳統(tǒng)醫(yī)藥市場成熟，對我國中藥有較高的接受程度和廣泛應(yīng)用。2004年1月1日頒布實(shí)施的《天然藥品管理辦法》標(biāo)志中國傳統(tǒng)中藥以天然藥品身份依法納入加拿大藥品注冊監(jiān)管?；诩幽么蟋F(xiàn)有的天然藥品監(jiān)管體系，結(jié)合注冊實(shí)踐，總結(jié)加拿大衛(wèi)生部對于天然藥品的注冊申請要求及審評關(guān)注點(diǎn)，分析我國不同類型的中藥產(chǎn)品如何以最合適的申報(bào)路徑進(jìn)入加拿大市場，以期為傳統(tǒng)中藥的國際化提供借鑒和參考，推動中藥國際化的進(jìn)一步發(fā)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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國家重點(diǎn)研發(fā)計(jì)劃資助項(xiàng)目（2024YFC3507301）； 2024 年藥品監(jiān)管科學(xué)全國重點(diǎn)實(shí)驗(yàn)室第二批課題（2024SKLDRS0221）