浅谈PSUR制度对我国药品不良反应报告制度的启示

The PSUR System to the Implications of Chinese Adverse Drug Reaction Reporting System

通过对国际通行的药品安全性更新报告(PSUR)制度相关规定及其特点进行分析,提出我国推广和完善PSUR制度的意义,为完善我国药品不良反应报告制度、加强药品上市后的安全监管、保障公众的用药安全提供服务。

By analyzing the relevant provisions of descriptions and characteristics of the PSUR system,included the background and significance of the PUSR development,the contents of the requirements and data sources,the frequency of reporting and the main responsibility. It recommend that China should improve and promote the PSUR system,as to be a complement of Chinese adverse reaction reporting system,while clarified its main reporting and improved enterprise on a regular basis to report adverse reactions and sense of responsibility.