数据保护制度对创新药品可获得性正向效应研究——基于左乙拉西坦中美上市准入比较分析  

Study on the positive effects of data protection system on the availability of innovative drug——based on a comparative analysis of keppra marketing between China and America

作　　者：丁锦希[1] 丁志琛[1] 徐卓环[1] 任宏业[1] 戴睿婕 

机构地区：[1]中国药科大学医药知识产权研究所,南京211198

出　　处：《上海医药》2014年第17期56-60,共5页Shanghai Medical & Pharmaceutical Journal

基　　金：国家社会科学基金项目(13BFX120):TRIPS框架下中国药品试验数据保护制度研究

摘　　要：本文通过分析我国创新药品可获得性现状与影响因素,在理论上分析基础上,比较左乙拉西坦(Keppra)在中美上市准入情况与数据保护强度,探究药品数据保护与创新药品可获得性之间的关系。药品数据保护制度可有效促进国外创新药品尽快进入我国市场。建议我国尽快完善药品数据保护制度,以期提高我国新药可获得性,保障公众健康福利。The situation of marketing approval and the data protection strength of Keppra were compared between China and America by theoretical analysis of status quo of the availability of innovative drug and the influencing factors in China, so as to explore the correlation between data protection system and innovative drug availability. We thought that drug data protection system could effectively facilitate the foreign innovative drug to enter Chinese market. A suggestion on the improvement of drug data protection system as soon as possible in China was proposed so as to enhance new drug availability in China and ensure public health welfare.

关 键 词：数据保护 创新药品 可获得性 KEPPRA 

分 类 号：R951[医药卫生—药学]