中国食品药品监管Issue(3)：34-43,10.DOI:10.3969/j.issn.1673-5390.2025.03.004
中美组合产品审评制度机制的分析和启示
Analysis and Insights into the Review Institutions and Mechanisms for Combination Products between China and the United States
张源 1顾小春2
作者信息
- 1. 国家药品监督管理局政策法规司
- 2. 东南大学医学院
- 折叠
摘要
Abstract
The development of combination products,which integrate pharmaceuticals and medical devices,often offers unique clinical advantages over single drug or medical device applications,making it a hot area in pharmaceutical research and development.In China,the regulatory review system for combination products is fundamentally sound.However,in practice,challenges remain in areas such as product jurisdiction classification,review coordination,and communication,which do not fully meet the demands of innovative product development.This suggests that further improvements are needed in the regulatory framework.By contrast,the United States has a relatively well-established combination product review system and is at the forefront of innovation in this field.This article analyzes the review and regulatory mechanisms for combination products in China and the United States,and the challenges facing China's regulatory system,and proposes policy and operational improvements to better support the needs of innovative product development.关键词
组合产品/属性界定/审评制度/审评机制Key words
combination product/product jurisdiction classification/review institutions/review mechanisms分类
医药卫生引用本文复制引用
张源,顾小春..中美组合产品审评制度机制的分析和启示[J].中国食品药品监管,2025,(3):34-43,10.
