中美药械组合产品属性界定工作与对比分析

Introduction and comparative analysis on the jurisdictional designation of drug-device combination product between China and the United States

在鉴于创新型药械组合产品不断涌现的新形势下,借鉴美国食品药品监督管理局(FDA)科学监管经验有助于提升我国药械组合产品属性界定的工作效率。从我国药械组合产品和(或)美国组合医疗产品的定义、指导文件以及属性界定的机构设置与职能、申请资料、申报流程等方面进行对比,系统梳理中美两国对于药械组合产品属性界定的监管要求及现状,从而为我国药械组合产品属性界定的科学规范管理提出监管对策。

Under the new situation that innovative drug-device combination products are constantly emerging,learning from FDA’s successful supervision experience would contribute to improve the work efficiency of jurisdictional designation of drug-device combination product of China.A series of aspects,including the definitions of drug-device combination products of China and(or)combined medical products of the United states,guidance documents,organization structuring and functions of jurisdictional designation,application materials and application procedures,were compared.The requirements and current situations of jurisdictional designation of drug-device combination product of China and the United States were systemically sorted so as to propose the countermeasures of supervision and management for scientifically standard management of jurisdictional designation of drug-device combination product of China.