药械组合产品属性界定工作现状及对策研究

Research on Current Situation and Countermeasures of Drug-device Combination Product Attribute Definition

目的:为提升药械组合产品属性界定的申请资料质量、提高属性界定工作效率提出建议。方法:对比分析中美2009年至2019年属性界定申请现状和监管政策、分析我国属性界定工作存在的问题。结果与结论:对于药械组合产品属性界定的受理、审查和复审环节容易出现的问题提出解决对策。借鉴美国FDA管理经验,提出提升我国药械组合属性界定工作质量和效率的建议。

Objective:To put forward several suggestions for improving the quality of application materials and the efficiency of attribute definition of drug-device combination products.Methods:The present situation and regulatory policies of application for attribute definition in China and the United States from 2009 to 2019 were contrastively analyzed,and the problems existing in attribute definition work in China were analyzed.Results and Conclusion:Relevant countermeasures for common problems in the process of acceptance,examination and review of the definition of the attributes of the combination products were proposed.Based on the management experience of FDA,some suggestions were put forward to improve the quality and efficiency of the definition of pharmaceutical device combination attribute definition in China.