2002-2004年上海市获得生产批件的药品投产情况调查  

Investigation of production of drugs obtaining production licences during 2002-2004 in Shanghai

作　　者：吴浩[1] 高敏洁[1] 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海200020

出　　处：《药学服务与研究》2007年第6期439-441,共3页Pharmaceutical Care and Research

基　　金：2004年度上海市科技发展基金软科学研究重点课题

摘　　要：目的:调查上海市获得生产批件药品的生产情况,为本市的新药研发和监管提供参考。方法:对2002-2004年上海市药品获得生产批件的数据进行统计,调查相关品种的投产情况,并对未投产原因进行分析。结果:本市获得生产批件的350个药品中,189个(54.0%)已投入生产,其中有166个(47.4%)在获得生产批件后1年内投产。结论:应进一步加强药品生产批件的管理,提高获得生产批件药品的投产率。Objective：To investigate the production of drugs obtaining production licences in Shanghai in order to provide references for research,development and administration of new drugs. Methods： The data of drugs obtaining production licences during 2002--2004 in Shanghai were statistically analyzed. A survey of production of related drugs was conducted and the rea- sons for not being produced were analyzed. Results： There were 189（54.0 %） drugs being produced among 350 drugs obtaining production licences and 166 of them were produced within one year. Conclusion： The administration of drug production licences should be further enhanced. The rate of putting into production of drugs obtaining production licences should be increased.

关 键 词：药品生产批件 药品生产 上海 

分 类 号：R95[医药卫生—药学]