美国药品上市后再评价法律制度实施的研究及其对我国的启示  

Study on the Implementation of American Post-marketing Re-evaluation of Drugs Legal System and Its Enlightenment to China

作　　者：张琪[1] 颜建周[1] 马旭锋 邵蓉[1] ZHANG Qi;YAN Jianzhou;MA Xufeng;SHAO Rong(National Drug Policy and Medical Industry Economy Research Center of China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国家药物政策与医药产业经济研究中心

出　　处：《中国药房》2019年第15期2017-2022,共6页China Pharmacy

基　　金：国家社会科学基金资助项目(No.15BZZ052,No.15ZDB167);江苏省社科应用研究精品工程(No.18SYB-150)

摘　　要：目的:为建立并完善我国药品上市后再评价(以下简称"再评价")法律制度提供借鉴。方法:通过对美国再评价体系进行梳理,重点研究美国再评价法律制度实施现状与程序,以此提出完善我国再评价法律制度的建议。结果与结论:美国的再评价体系以企业为执行主体、政府为监督主体,具有过程高度信息化和透明化的特点,其工作内容包括药品不良反应报告和监测制度、定期报告制度、上市后临床试验及研究制度三部分,实施流程为发现线索、美国FDA初步审查并通知、企业深入自查与审查、企业行动并接受美国FDA监督。建议我国建立再评价法律制度时,应凸显患者的主体作用,引导公众实现风险沟通,如可参考美国FDA的Medwatch自愿报告系统;建立统一的数据收集、存储系统和科学的数据处理方法;不断强化制药企业检测、报告的主体责任意识,不断降低患者用药风险。OBJECTIVE:To provide reference for the establishment and improvement of the post-marketing re-evaluation of drugs(shorted for re-evaluation)legal system in China.METHODS:Through sorting out American re-evaluation system,this paper focused on the current situation and procedures of the implementation of American re-evaluation system and put forward the suggestions for improving drug re-evaluation system in China.RESULTS & CONCLUSIONS:American re-evaluation system takes enterprises as the main body of execution and the government as the main body of supervision.It has the characteristics of highly informatized and transparent process.The work includes the report of ADR implementation of monitoring systems,the periodic reporting system and the post-listing clinical trials and research systems.The implementation process is to find clues,FDA preliminary review and notification,enterprise further self-examination and review,corporate actions and accept FDA supervision.It is suggested that when establishing the legal system of re-evaluation system in China,the main role of patients should be highlighted,and risk communication should be guided by the public.For example,the Medwatch voluntary reporting system of FDA can be imitated.The unified data collection,storage system and scientific data processing methods can be established.Continuously strengthen the main responsibility consciousness of pharmaceutical enterprises in testing and reporting,and constantly reduce the risk of drug use of patients.

关 键 词：药品上市后再评价 法律制度 美国食品药品监督管理局 启示 

分 类 号：R951[医药卫生—药学]