加拿大处方药与非处方药分类管理制度研究与借鉴

Research and reference on the classification management system of prescription drugs and non-prescription drugs in Canada

目的 借鉴加拿大处方药与非处方药分类管理制度,为完善我国处方药与非处方药分类管理提供借鉴。方法 通过分析加拿大处方药与非处方药分类管理制度内容和经验,提出完善我国处方药与非处方药分类管理的思路。结果与结论 按照处方药与非处方药分类,加拿大将药品分为第Ⅰ类药品、第Ⅱ类药品、第Ⅲ类药品和未分类药品,并对药品分类确立了具体评价因素和管理要求,建有一套比较系统的管理制度、体系和技术标准,这对完善我国处方药与非处方药分类管理制度具有参考和借鉴价值。笔者建议借鉴加拿大处方药和非处方药制度和管理模式,进一步完善我国药品分类管理制度和配套政策,加强处方药和非处方药的精细化分类管理,完善分类注册和转换审查标准。

OBJECTIVE To provide reference for improving the classification management of prescription drugs and non-prescription drugs in China by learning from the classification management system of prescription drugs and non-prescription drugs in Canada. METHODS The content and experience of classification management system of prescription drugs and non-prescription drugs in Canada were analyzed, and the thinking of the classification management of prescription drugs and non-prescription drugs in China was proposed. RESULTS & CONCLUSIONS According to the classification of prescription drugs and non-prescription drugs, drugs can be divided into class Ⅰ drugs, class Ⅱ drugs, class Ⅲ drugs, unclassified drugs in Canada. Specific evaluation factors and management requirements have been established for drug classification. Canada has established a set of systematic management systems and technical standards, which has reference value for improving the classification management system in China. It is suggested to further improve the drug classification management system and supporting policies, strengthen fine classification management of prescription drugs and non-prescription drugs and improve classification registration and transformation review standards in China, by learning from Canadian prescription drug and non-prescription drug system and management model.