医疗产品紧急授权政策梳理及启示

Analysis on emergency authorization policies of medical products

新型冠状病毒感染的肺炎疫情暴发,提醒我国加强应对突发公共卫生事件能力的重要性。制定快速有效的医疗产品紧急授权制度是应对突发公共卫生事件重要手段。本文通过梳理美国应对公共卫生突发事件的紧急授权相关政策,为我国制定紧急情况下医疗产品授权制度提供参考。

The outbreak of pneumonia caused by novel coronavirus reminds us of the importance of strengthening China’s capacity in order to respond to public health emergencies.Rapid and effective emergency authorization system of medical products is an important tool to deal with public health emergencies.This paper provides a reference for China to build up the authorization system of medical products under emergency situations by sorting out the emergency authorization policies of the United States in response to public health emergencies.