上市许可持有人制度下药品生产企业不良反应监测模式探讨  

ADR monitoring in pharmaceutical manufacturers under the background of marketing authorization holder system

作　　者：王长之[1] 陈晓博 刘曦朦 刘超[1] WANG Changzhi;CHEN Xiaobo;LIU Ximeng;LIU Chao(Food and Drug Evaluation Center,Zhengzhou,Henan 450006,China)

机构地区：[1]河南省食品药品评价中心,河南郑州450006

出　　处：《安徽医药》2020年第5期1056-1060,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：目的探讨上市许可持有人制度下生产企业如何开展药品不良反应监测工作,促进企业落实药品安全主体责任。方法对我国关于生产企业药品不良反应监测的相关法律法规进行梳理,结合2015—2018年对本省企业进行药品不良反应监测实地检查情况,对我国生产企业监测现状及存在的主要问题进行分析。结果目前我国药品生产企业不良反应监测存在监测体系不健全、报告收集途径不通畅、数据利用度不高等问题。结论生产企业应通过健全内部监测体系、协助医疗机构建立CHPS系统、建立专门的药物警戒数据库、借助“外脑”会商等措施,畅通报告收集渠道,提高自身分析评价能力,主动加强风险识别和控制,为公众用药安全提供保障。Objective To explore the way to develop adverse drug reaction(ADR)monitoring in pharmaceutical manufacturers un der the background of marketing authorization holder(MAH)system,and to promote pharmaceutical manufacturers fulfilling their main responsibility for drug safety.Methods Based on the relevant laws and regulations of ADR monitoring in pharmaceutical manufacturers and the on site inspection results in Henan Province during 2015 2018,we analyzed the status quo and problems of ADR monitoring in pharmaceutical manufacturers.Results There were problems such as inadequate monitoring system,unsmooth channel of report collection,and low information utilization.Conclusions Thepharmaceutical manufacturers should improve the in ternal monitoring system,assist medical institutions to establish theChina Hospital Pharmacovigilance system(CHPS),createtheir own professional pharmacovigilance databases and draw on the“outside brain”,so that they can maintain the smooth channels of re port collection,improve their analytical and evaluation capabilities,and actively strengthen risk identification and management to provide protection of drug safety for the public.

关 键 词：药物毒性 药物副反应报告系统 药物警戒性 安全管理 上市许可持有人 生产企业 

分 类 号：R95[医药卫生—药学]