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.
关键词
药品试验数据/数据保护/保护范围/保护期限
Key words
drug trial data/data exclusivity/protection scope/duration of protection
维普
万方数据