Interpretation and reflection of Traditional Chinese Medicine registration evidence system in Canada
10.3760/cma.j.cn115398-20210508-00057
- VernacularTitle:加拿大中药注册证据体系解读和思考
- Author:
Jie LIN
1
;
Longhui YANG
;
Yong TAN
;
Dongmei GUO
;
Yaqing LIU
;
Yuanchun MA
;
Zixu WANG
;
Jing'an BAI
;
Huimin HU
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:
Canada;
Traditional Chinese Medicine (TCM);
Registration;
Evidence system;
Referantial significance
- From:
International Journal of Traditional Chinese Medicine
2022;44(3):251-256
- CountryChina
- Language:Chinese
-
Abstract:
Traditional Chinese Medicine (TCM) products could be registered as natural health products (NHPs) in Canada. Its registration process could be mainly divided into simple-application, traditional-application and non-traditional application. By analyzingi the TCM registration evidence system and its safety, effectiveness and quality required by different registration categories in Canada, we found that "simple-application" procesure needs to submit evidence based on the parameters of a component in the monograph. As for "traditional application", TCM products need to be used at least 50 years with, traditional material or Pharmacopoeia can be used as evidence; As for non-traditional application, TCM products need to provide evidence according to the disease risk level, and most of them need to provide scientific experiment evidence. Therefore, from the experience of TCM registration evidence system in Canada, the registration of TCM products should pay attention to improve the its classification method, refining its evidence requirements and data types, promoting the formulation of monograph of TCM, realizing the scientific evaluation and rapid review of classic famous prescriptions, and promoting the inheritance and innovative development of TCM in China.
