2000—2015年欧盟孤儿药认定及上市情况分析  

An analysis on designation and marketing authorizations of orphan medicinal products from 2000 to 2015 in EU

作　　者：李轩[1] 都晓春[1] 宗欣[2] LI Xuan DU Xiao-chun ZONG Xin(School of Management, Changchun University of Chinese Medicine, Changchun 130117, China Information Center of China Food and Drug Administration, Beijing 100053, China)

机构地区：[1]长春中医药大学管理学院,长春130117 [2]国家食品药品监督管理总局信息中心,北京100053

出　　处：《中国新药杂志》2016年第24期2761-2765,共5页Chinese Journal of New Drugs

摘　　要：通过欧盟药品监督管理局、欧盟委员会网站查阅,收集2000—2015年欧盟孤儿药政策法规、孤儿药认定及上市许可信息。孤儿药法规实施16年来,欧盟认定了1 596个孤儿药(年均约100个),上市许可121个孤儿药(年均约8个)。本文在分析欧盟孤儿药政策法规的基础上,对2000—2015年欧盟孤儿药认定和上市许可情况进行分析,为我国孤儿药政策法规制定和孤儿药研发提供参考。We read the regulations and policies on orphan medicinal products, and collected the information of designation and marketing authorization for orphan medicinal products on the EMA and European Commission websites. Since this regulation for orphan medicinal products has entered into force for 16 years, 1596 medicines （annual average of about 100） have been granted orphan status by the European Commission, and 121 orphan designated medicines （annual average of about 8） have been authorized for marketing in the European Union. On the basis of the analysis of European policies and regulations for orphan medicinal products, we statistically analyzed the designation and marketing authorization for orphan medicinal products between 2000 and 2015, for providing a reference to enaction of orphan medicinal products＇ policies and regulations, and its research and development in China.

关 键 词：欧盟 孤儿药法规 孤儿药委员会 孤儿药认定 上市许可 

分 类 号：R95[医药卫生—药学]