药械组合产品上市后质量安全监管的国际经验探讨

Discussion on the International Experience of Post-market Quality and Safety Supervision of the Combination Products

本文通过查阅和收集来自美国、日本、加拿大、欧盟等国家和地区有关药械组合产品的政策文件,总结分析药械组合产品上市后质量安全监管的制度规范,为我国药械组合产品的质量安全监管提供参考。研究发现,国际各国在指导规范的制定与有效实施,强化企业主体责任和积极上报意识,建立第三方评估与监督机制以及落实产品不良反应/事件监管和召回制度等方面较为重视。

This paper consults and collects policy documents from the United States,Japan,Canada,the European Union and other countries and regions on combination products,and focuses on summarizing and analyzing the system specifications of post-market product quality and safety supervision,providing reference for the quality and safety supervision of combination products in China.The study found that international countries attach great importance to the formulation and timely follow-up of guidance norms,the main responsibility of enterprises and the awareness of active reporting,the establishment of third-party evaluation and supervision mechanisms,and product adverse reaction/event monitoring and recall systems.