日本药品上市后评价制度研究  

Research on System of Post-marketing Evaluation in Japan

作　　者：刘佳[1] 李承霖 郭俐宏 河合秀晃 寺井嘉哉 岩崎典之 铃木美和子 杨威[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045 [2]安斯泰莱制药(中国)有限公司,北京100022 [3]ァステラス制药株式会社,日本东京103-8411

出　　处：《中国药物警戒》2017年第3期158-160,164,共4页Chinese Journal of Pharmacovigilance

基　　金：国家食品药品监督管理总局课题(C201501):药物警戒法律制度比较研究

摘　　要：目的学习和总结发达国家药品上市后评价制度设计和框架,为建立我国药品上市后评价体系提供参考。方法查阅并总结日本药品上市后评价相关文献资料。结果日本通过30年的法规修订,形成了以药品不良反应和感染报告制度为基础、再审查制度为主线的药品上市后评价体系,内容涵盖上市后早期监测(EPPV)、定期安全性更新报告(PSUR)、风险管理计划(RMP)以及药物使用效果调查等制度。制度的执行严格遵循药物警戒质量管理规范(GVP)和上市后研究质量管理规范(GPSP)要求。此外,针对超出再审查期的药品还建立了即时再评价制度作为补充。结论日本已形成一套完善的药品上市后评价体系,相关经验对我国开展相关工作具有参考意义。Objective To provide references for the post-marketing evaluation system in china by studying and summarizing the design and framework of the post-marketing drug evaluation system in developed countries. Methods The related literatures of post-marketing evaluation in Japan were reviewed and summarized. Results Japan has established a post-marketing drug evaluation system which is based on the adverse drug reactions and infection reporting system. The reexamination system that includes Early Post-marketing Phase Vigilance （EPPV）, Period Safety Update Report （PSUR）, Risk Management Plan （RMP） and drug use investigation is the main line for this post-marketing drug evaluation system. The implement of the system must be follow Good Vigilance Practice （GVP） and Good Post-marketing Study Practice （GPSP）. Additionally, an Ad Hoc reevaluation system is established as a part of post-marketing drug evaluation system for the drugs out of the reexamination period. Conclusion Japan has developed a comprehensive system for drug post-marketing evaluation. The experience in the post- marketing evaluation system from Japan has a reference value for China to carry out related work.

关 键 词：日本 药品 上市后 评价 

分 类 号：F195[经济管理—世界经济]