加拿大天然健康产品质量管理的要求与思考

Requirements and thinking on quality management of Natural Health Products in Canada

采用文献研究法,解读加拿大卫生部《天然健康产品质量指南》对天然健康产品(NHP)的质量管理和质量控制的政策文件。该指南从利益相关者的角度,对NHP的特征描述、鉴定试验、成分含量(定量分析和量化输入)、污染物及杂质含量检测等项目的检测方法和标准提供要求,确保NHP生产全过程的质量管理和质量控制。了解加拿大NHP质量管理的要求,可保证中药产品在生产环节符合当地相关要求,促进中药产品在海外市场的高质量发展。同时,为完善我国药品质量管理系列文件提供参考依据,促进中成药注册相关质量标准与国际质量标准形成有效衔接。

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.