摘要
二十一世纪以来,各种传染病疫情频发,严重危害公众生命健康。在突发公共卫生事件且现已上市药品均无法满足医疗需求的紧急状态下,确保应急药品的供应,强化药品监管体制中的药品应急监管工作是遏制疫情解决突发公共卫生事件的关键所在。本研究采用文献研究的方法,分析我国针对突发公共卫生事件的药品审批机制目前所存在的问题,借鉴国外已有的相关经验,提出可行性建议,就遇到重大公共卫生事件在已上市药品无法满足防治需求时,如果有相关正在研发的药物,为应对紧急突发事件,如何进行应急审批和使用管理作出规定。
Since the 21 st century, various infectious diseases have frequently and seriously harmed public life and health. In public health emergencies when the marketed drugs were unable to meet the medical needs of emergency, ensuring the supply of emergency medicine and strengthening drug regulatory system in emergency medicine management is a key to solve the public health emergencies. In this article, the method of literature research is used to analyze the currently existing problems of drug approval mechanism for public health emergencies. Referring to the existing relevant experience abroad, this article puts forward feasible suggestions on the managements of drug approval and utilization if there are relevant developing drugs, when we are faced with public health event that marketed drugs are unable to meet the medical needs of emergency.
出处
《中药与临床》
2016年第3期64-66,共3页
Pharmacy and Clinics of Chinese Materia Medica
关键词
突发公共卫生事件
应急药品
审批
Public health emergencies
emergency medicine
drug approval
