2010-2014年EMA药品审评情况分析

An analysis on human medicines recommended by EMA from 2010 to 2014

通过欧盟药品监督管理局(EMA)网站查阅、收集2010-2014年EMA年度报告信息,着重对其药品审评情况进行纵向统计分析,供医药界同仁参考。2010-2014年欧盟年均批准新药(非孤儿药)35个、孤儿药9个、生物类似药2个等;年均药品审评时间为270 d(企业补充材料时间除外)。EMA新药审评数量之多及较合理的审评时间,离不开其对新药研发的政策支持。如,提供科学建议与方案指导,给予中小型企业研发支持和成立创新工作组等。孤儿药、儿科药、先进治疗医药产品与草药(植物药)等领域都有其对应的科学委员会和具体的监管政策、法规。

By collecting and reading the annual reports（ 2010- 2014） of EMA on the EMA website,we make a longitudinal statistical analysis on the drug evaluation for providing the reference to the medical field. The European Commission had approved average annual 35 new drugs（ non-orphan）,9 orphan drugs,2 similar biological products and so on from 2010 to 2014; and the average assessment time（ except the time of company clockstop） is 270 days. The number of new drugs and more reasonable evaluation time can not be separated from EMA＇s policy for new drug RD,such as providing scientific advice and protocol assistance,supporting to small and medium-sized enterprises＇ RD and setting up the innovation task force etc. Orphan drugs,paediatric medicines,advanced therapy medicinal products,herbal medicinal products and so on have their own specific scientific committee,regulatory policies and regulations.