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

作　　者：张源 顾小春[2] ZHANG Yuan;GU Xiao-chun(Department of Policies and Regulations,National Medical Products Administration;School of Medicine,Southeast University)

机构地区：[1]国家药品监督管理局政策法规司 [2]东南大学医学院

出　　处：《中国食品药品监管》2025年第3期34-43,共10页China Food & Drug Administration Magazine

摘　　要：药品与医疗器械组合应用而开发的组合产品,相较于单一的药品或者医疗器械往往具有独特的临床优势,成为医药研发的热点领域。我国药械组合产品的审评制度机制基本健全,但实践中药械组合产品的属性界定、审评协调、沟通交流等尚有不完全适应产品创新研发需要的情形,提示相关制度机制仍有完善空间。从国际监管实践看,美国具有相对健全完善的组合产品审评制度,相关产品创新研发也处于领先地位。本文主要分析中国和美国组合产品的审评制度机制,以及我国组合产品审评管理面临的挑战,围绕建立更好地适应产品创新研发需要的审评管理体系,提出完善相关制度机制的改进方向。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 

分 类 号：R95[医药卫生—药学]