欧盟特殊审评药品上市后安全监管措施研究

Safety management measures of post-authorization study on drugs authorized through expedited review approaches in European Union

经欧洲药品管理局(European Medicines Agency,EMA)特殊审评通道上市的药品在加速上市的同时,也需要接受更严格的上市后监管。通过文献分析的方法,在系统梳理相关法规和文献的基础上,对EMA特殊审评药品上市后安全监管体系及其特殊要求进行了分析和介绍,并结合中国药品审评审批改革和特殊审评药品上市后监管现状,从管理理念、法规建设、上市许可持有人制度以及药品再评价体系的建设和完善方面提出了政策建议。

Drugs are authorized through expedited review approaches by European Medicines Agency(EMA) with preferential policies which accelerated to the market, meanwhile, they should also accept stricter post-authorization regulation. This paper introduce and analyze the post-authorization policy requirements of drugs authorized through an expedited review approaches in EMA. Combined with the current situation of expedited review and relevant post-authorization monitoring policies in China,detailed suggestions were put forward with aspects includes the conceptual understanding of administration, establishment of the laws and regulations, the necessity of improving of the re-evaluation system, to improve the pharmacovigilance system in China.