摘要
Abstract
The drug safety regulatory system refers to the comprehensive management system composed of drug-safety related agencies,which involves aspects such as laws and regulations,registration and approval,production and circulation supervision,punishment,and supervision mechanisms to ensure drug quality and public safety.This paper reviews the development of China's drug safety supervision system,examining the concepts,supervision system construction,efficiency,and methods of supervision.It discusses the relationship between drug safety supervision and system construction,affirming the effectiveness of an independent and authoritative drug safety supervision system and recognizing the current large market multi-department integrated supervision system.At the same time,it also scientifically addresses the challenges faced during the development of the drug safety supervision system,explores the reasons for the lack of grassroots drug safety supervision,and analyzes existing safety risks.This paper puts forward thoughts on the establishment of a scientific and efficient drug safety regulatory system,aiming to innovate regulatory methods,enhance regulatory effectiveness,and further build a scientific,pragmatic,and advanced drug safety regulatory system.The goal is to promote a revitalized and vigorous drug safety supervision model under the large market supervision system.关键词
药品安全监管/体制建设/大市场监管体制/监管理念/监管模式Key words
drug safety supervision/institutional building/large market supervision system/supervision concept/supervision mode分类
医药卫生
