摘要
回顾欧洲联盟药品监管科学战略计划的发展历程,以期为我国药品监管科学发展和监管能力提升提供借鉴。本文采用文献研究法对欧洲联盟药品监管和监管战略的发展历史进行了回顾,《面向2025EMA监管科学战略》是欧洲药品管理局战略的第四阶段。通过四个阶段的战略,欧洲联盟旨在建立卓越网络工作模式,遴选公共卫生、罕见病等战略优先点,并进一步聚焦新兴科技对审评的挑战方面,监管监管科学逐步上升为欧洲药品管理局提升监管能力,应用对日新月异的药物研发创新挑战的一种新方法。
This paper looked back to the development process of the Europe Union(EU)regulatory science strategy,in order to provide reference for the regulatory science development of drug administration and the improvement of administration capability in China.Through reviewing the development history of EU drug regulatory science strategy by using the method of literature research,European Medicines Agency(EMA)Regulatory Science Strategy to 2025 is the fourth stage of EMA strategy.During the four-stage strategy,the EU aims to establish an excellent network working model,select strategic priorities such as public health and rare diseases,and then further focus on the challenges of emerging technologies to the drug review.Regulatory science has gradually risen to EMA to improve the administration capability,and apply a new method to solve the challenges of evolving drug research,development and innovation.
作者
李峰
LI Feng(Center for Drug Evaluation,National Medicinal Products Administration,Beijing 100022,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2021年第22期3204-3208,共5页
The Chinese Journal of Clinical Pharmacology
关键词
欧洲联盟
欧洲药品管理局
监管科学
战略
Europe Union
European Medicines Agency
regulatory science
strategy
