中日创新药物监测期制度的比较研究  

Comparative analysis of the innovative drug monitoring period system between China and Japan

作　　者：丁锦希[1] 李媛[1] 王颖玮[1] 

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《中国新药杂志》2012年第16期1840-1845,共6页Chinese Journal of New Drugs

基　　金：国家社会科学基金(10CFX055)

摘　　要：本文系统介绍了中日两国新药监测期制度,通过两国制度对比找出我国新药监测期制度的不足,进而得出完善我国相关制度的政策建议。日本新药监测期制度积累了较为成熟的机制,值得我国借鉴。This paper presents an in-depth introduction of the purposes and features of the innovative drug monitoring period systems in China and Japan. Suggestions are made to improve this system through comparative a- nalysis between China and Japan. China should draw lessons from Japanese innovative drug monitoring period system.

关 键 词：新药监测 再审查制度 药品数据保护 

分 类 号：R95[医药卫生—药学]