论文部分内容阅读
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。
Through the EU Drug Administration, the European Commission website to collect, collect the 2000-2015 EU orphan drug policies and regulations, orphan drugs and licensing information. For 16 years since the orphan medicine regulation was implemented, the EU has identified 1 596 orphan medicines (about 100 a year on average) and listed 121 orphan medicines (about 8 a year on average). Based on the analysis of the orphan drug policies and regulations in EU, this article analyzes the status of orphan drug certification and marketing authorization in the EU from 2000 to 2015, and provides reference for the development of orphan drug policies and regulations and orphan drug research and development in China.