创新性化学药品在中国的申报状况研究  

Research in Profile of Chemical Investigational New Drug Application in China

作　　者：杨志敏[1] 史继峰[1] 温宝书[1] 杨建红[1] 冯毅[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《食品与药品》2009年第3期1-3,共3页Food and Drug

摘　　要：通过对2005～2008年期间在我国申报的创新性化学药品的申请情况进行系统性分析,明确目前我国创新性药品研发和申报的现状。研究结果表明,创新性药品的申请数量近年来基本稳定,总体上国产申请和进口申请数量相近,申报的适应证领域比较集中,趋势与国际情况相似。Through the systematical analysis in chemical investigational new drug （IND） applications from 2005 to 2008, the current situation of IND applications is confirmed. The results show that the number of applications keeps stable in recent years and that of imported and local applications is almost the same. The indications of those applications are relatively concentrated and the tendency is similar to that in the international reports.

关 键 词：创新性药品 审评 申报 

分 类 号：R95[医药卫生—药学]