Requirements and thinking on quality management of Natural Health Products in Canada
10.3760/cma.j.cn115398-20221101-00005
- VernacularTitle:加拿大天然健康产品质量管理的要求与思考
- Author:
Jiayin WEI
1
;
Yong TAN
;
Longhui YANG
;
Lin LIN
;
Bo WEN
;
Xiaoyu FENG
;
Xiangpeng WANG
;
Jiani TAN
;
Yuwen XIA
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:
Quality control;
Drug quality management;
Natural Health Products
- From:
International Journal of Traditional Chinese Medicine
2023;45(11):1360-1365
- CountryChina
- Language:Chinese
-
Abstract:
Introduces the regulatory requirements of the Natural and Over-the-Counter Health Products Administration on the quality of natural health products, and adopts the literature research method to translate and interpret Health Canada's "Guidelines for the Quality of Natural Health Products" on the quality management and quality control of natural health products. Policy documents, from the perspective of stakeholders, provide requirements for the detection methods and standards of natural health products, such as characterization, identification experiments, component content, pollutants and impurity content detection, etc. To achieve natural health Quality management and quality control in the whole process of product production. Familiar with and understand the requirements for the quality management of natural health products in Canada will help to promote the legal and compliant management of product quality in the production process of Traditional Chinese Medicine (TCM) products after registration in Canada, and promote the production and sustainable development of TCM products. At the same time, it provides a reference for further improving my country's drug quality management system normative system documents, and assists the effective connection between the registration-related standards of Chinese patent medicines and international standards.
