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Research and Suggestions on the Registration Application of Traditional Chinese Medicines in Canada

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Author:
No author available
Journal Title:
Pharmacology and Clinics of Chinese Materia Medica
Issue:
6
DOI:
No doi available
Key Word:
加拿大;天然健康产品;注册管理;技术要求;中药;注册申报;Canada;Natural health products;Registration regulation;Technical requirement;Traditional Chinese medicines;Registration application

Abstract: A comprehensive understanding of the regulations and technical requirements for the registration of traditional Chinese medicines(TCMs)in overseas countries is one of the key links in promoting the globalization of TCMs and making TCMs benefit the people around the world.Canada is a Western country that attaches great importance to TCMs.The Natural Health Products Regulations promulgated and imple-mented in 2004 marked the establishment of the regulatory system for natural health products(NHPs)in Canada.The Natural Health Prod-ucts Management of Applications Policy promulgated and implemented in June 2019 defines the application classification,types,and corre-sponding requirements of NHPs.TCMs are generally registered as NHPs,a subcategory of drugs,and managed as over-the-counter drugs in Canada.China has sound regulations and technical requirements for the registration of TCMs,which provide a good legal basis and favorable conditions for TCMs to enter the Canadian market as drugs.This paper summarizes the characteristics of the regulatory system and technical requirements for the registration of NHPs in Canada and explores the application strategies,pathways,and other key issues for the registration of TCMs in Canada.This paper is expected to provide reference for the registration and marketing of TCMs in Canada.

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