中国药品试验数据保护制度研究

Research on China's Drug Trial Data Exclusivity System

2022年,国家药监局发布《药品管理法实施条例(修订草案征求意见稿)》,提出建立药品试验数据保护制度。目前,该制度仍在讨论中,数据保护对象、范围、期限等细节有待进一步明确。本文系统梳理域外国家和地区药品试验数据保护制度的核心内容、数据保护期限的测算方式,剖析我国建立药品试验数据保护制度面临的挑战,提出构建药品试验数据保护制度的政策建议及相关方案,为我国药品试验数据保护制度落地提供参考。

The National Medical Products Administration(NMPA)of China issued the Implementation Regulations of the Drug Administration Law(Revised Draft for Comment)in 2022,which proposed the establishment of a drug trial data exclusivity system.However,the system is still under discussion,and details such as objects,scope,and duration of data protection need further clarification.This paper systematically reviews the core contents of drug trial data exclusivity systems and the calculation method of data protection period in various countries and regions.It also analyzes the challenges faced by China in establishing such a system and puts forward policy suggestions and related proposals to support the implementation of drug trial data exclusivity systems in China.