欧盟儿童药品管理的经验及启示  

The Enlightenment of the Pediatric Drug Regulation Experience in European Union

作　　者：何淑旺 邱琼[2] 

机构地区：[1]北京大学工学院,北京100871 [2]国家食品药品监督管理总局综合司,北京100053

出　　处：《中国药物评价》2013年第5期298-301,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:近年来欧盟儿童药品管理发生了积极变化,通过对其经验做法进行分析和研究,为完善我国的儿童药品管理提供建议和参考。方法:通过文献查阅,梳理和分析欧盟的儿童药品管理法规体系和经验做法。结果和结论:参考欧盟经验,可从法规建设、审评机构建设、技术指南体系和研发激励机制等四个方面为我国儿童用药管理体系的建设、完善提供建议和参考。Objective： In order to provide adviees for the improvement of pediatric drug regulation in China, the positive changes on pediatric drug regulation in European Union（EU） have been studied and analyzed in the last few years. Method： The pediatric drug reg- ulations and experiences in EU were systemically analyzed through the literature research. Results and Conclusion： The construction of pediatric drug regulation in China can be improved in four aspects, including development of regulations, establishment of reviewing mechanism, technical guidelines and R＆D incentive mechanism based on the experience of EU.

关 键 词：欧盟 儿童药品 药品管理 

分 类 号：R951[医药卫生—药学]