浅析我国药物警戒制度  

A Preliminary Analysis of China's Pharmacovigilance System

作　　者：李爽宁 马韶青[1] LI Shuang-ning;MA Shao-qing(College of Humanities,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学人文学院

出　　处：《中国食品药品监管》2024年第11期142-151,共10页China Food & Drug Administration Magazine

摘　　要：我国自2019年开始实行药物警戒制度,该制度是在药品不良反应报告和监测制度基础上的改革与创新,标志着我国药品监管水平正在稳步提升。同时需要看到,我国药物警戒体系还面临着诸多挑战,重点体现在:药物警戒的立法体系有待完善、组织体系有待健全、技术体系有待加强等。本文基于我国药物警戒制度实施现状,建议从完善立法、建立科学组织体系、完善技术体系、采取“一体两翼”监测模式、多元主体协同治理等方面,考量完善我国药物警戒制度切实可行的路径,以期推动达到保障公众用药安全和维护公共卫生安全的目标。Since 2019,China has implemented a pharmacovigilance system,representing a reform and innovation based on the adverse drug reaction reporting and monitoring system,marking the steady improvement of China's drug supervision level.However,it should be noted that China's pharmacovigilance system still faces many challenges,mainly reflected in the need for improvement in the legislation system,organizational system,and technical system.Based on the current status of the pharmacovigilance system in China,this paper proposes feasible paths to improve the system by improving legislation,establishing a scientific organization system,strengthening the technical system,adopting a"one and two wings"monitoring mode,and promoting multi-stakeholder collaborative governance.These measures aim to ensure public drug safety and maintain public health security.

关 键 词：药品管理法 药物警戒 药品不良反应监测 制度 

分 类 号：R95[医药卫生—药学]