日本药品数据保护制度安全监控效应——基于舍曲林上市后风险管理实证分析

Safety monitoring of pharmaceutical test data protection in Japan and its implication——an empirical study of post-marketing risk management on sertraline

本文以辉瑞公司抗抑郁药舍曲林在日本的数据保护过程为研究对象,采用典型案例实证分析法,分析日本药品数据保护制度的安全监控机制。通过分析数据保护制度与上市后风险管理制度的配套实施过程,探讨数据保护制度的创新药物安全监控效应,以期为完善我国药品数据保护制度提供借鉴。

This paper aimed at analyzing the safety monitoring of pharmaceutical data protection in Japan, utilizing the case analysis method and taking the drug sertraline produced by Pfizer as an example. By analyzing the simultaneous implementation process of data protection and postmarketing risk management system, the safety monitoring effect of innovative drug on the data protection system was discussed, in order to provide specific reference and guidance for drug data protection system in our country.