Introduction and analysis of the registration process of Traditional Chinese Medicine as a natural health product in Canada
10.3760/cma.j.cn115398-20210508-00050
- VernacularTitle:中药在加拿大注册天然健康产品流程介绍与分析
- Author:
Huimin HU
1
;
Longhui YANG
;
Yong TAN
;
Dongmei GUO
;
Yuanchun MA
;
Zixu WANG
;
Jing'an BAI
;
Zhe YU
;
Bo WEN
Author Information
1. 中国中医科学院中医临床基础医学研究所，北京 100700
- Keywords:
Chinese patent drugs;
Canada;
Natural health products;
Registration by classification
- From:
International Journal of Traditional Chinese Medicine
2022;44(3):246-250
- CountryChina
- Language:Chinese
-
Abstract:
At present, the registration process of Traditional Chinese Medicine (TCM) in Canada is refering to the requirements of Natural Health Products (NHPs). In terms of registration material, both NHPs and TCM include plants, animals and minerals with medicinal components, but the fundamental difference between them is that TCM is guided by the basic theory of TCM. As for the registration classification of TCM in Canada, first of all, judge whether the product to be applied for is NHPs; Secondly, we should clarify the types and ways of registration, mainly including simple application, traditional application and non-traditional application, and provide application forms, label texts, summary reports, evidence, animal tissue forms, finished product specifications and other materials according to different requirements. At present, the successful registration experience of TCM products in Canada mainly mainly includes applying for superior varieties, selecting appropriate application channels, communicating with local health management units and providing sufficient scientific evidence and good clinical application records. The regulations on the registration of NHPs in Canada have not fully considered the particularity of TCM and the registration of TCM products is still facing some difficulties. In the future, we can learn from the registration process and requirements of the Health Canada, promote the interconnection and mutual recognition of the Pharmacopoeia of the People's Republic of China and the NNHPD monographs in Canada, reduce the obstacles to the local application for registration of TCM, and promote the further improvement of the international standards of TCM.
