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美国生物药上市后风险管理及对我国的启示
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篇名: 美国生物药上市后风险管理及对我国的启示
TITLE: Post-marketing Risk Management of Biopharmaceuticals in the United States and Its Enlightenment to China
摘要: 目的:借鉴美国生物药上市后风险管理经验,为我国生物药上市后风险管理提供参考。方法:通过研究美国FDA发布的指南文件、网站信息等资料,对美国生物药上市后风险管理进行分析,并以英夫利昔单抗为例先容其具体实施情况,总结其管理特点并提出对我国生物药上市后风险管理的启示及相关建议。结果与结论:美国生物药上市后的风险管理主要包括“风险评估与降低策略(REMS)“”上市后研究和临床试验制度”两方面,其中后者包括上市后要求(PMR)和上市后承诺(PMC)两类。以英夫利昔单抗为例,该药自1998年8月被美国FDA批准上市后,其生产厂家于2009年向FDA提交了REMS并获批,并先后5次提出上市后研究和临床试验。可知美国生物药上市后风险管理是由FDA通过出台具体指南,鼓励多角色参与风险管理,实现与患者的有效沟通,对生物药风险进行持续监管,以降低生物药的使用风险。对于生物药而言,我国尚未制定系统、具体的实施细则和指南,在上市后风险管理方面仍存在欠缺。建议我国可借鉴美国对生物药上市后风险管理的措施和制度,尽可能吸纳利益相关方参与上市后管理,通过与患者进行有效沟通以提升患者用药风险意识,并且进一步完善上市后研究管理制度,保障患者用药安全。
ABSTRACT: OBJECTIVE:To learn from the experie nce of post-marketing risk management of biopharmaceuticals in the United States,and to provide reference for post-marketing risk management of biopharmaceuticals in China. METHODS :By studying guidance documents and website information issued by FDA ,the risk management of biopharmaceuticals after marketing in the United States was analyzed. Taking infliximab as an example ,the specific implementation situation was introduced ,the management characteristics were summarized ,and the enlightenment and relevant suggestions were put forward for the risk management of biopharmaceuticals after marketing in China. RESULTS & CONCLUSIONS :The post-marketing risk management of biopharmaceuticals in the United States mainly includes two aspects as “risk evaluation and mitigation strategy (REMS)”and “post-marketing study and clinical trials system ”. The latter included post-marketing requirement (PMR) and post-marketing commitment(PMC). Taking infliximab as an example ,since it was approved by FDA in August 1998,its manufacturer submitted REMS to FDA in 2009 and obtained approval ,and proposed post-marketing studies and clinical trials for five times. It can be seen that FDA has issued specific guidelines for post-marketing risk management of biopharmaceuticals to encourage multi-role participation in risk management , realize effective communication with patients , and continuously supervise the risk of biopharmaceuticals,so as to reduce the risk of the use of biopharmaceuticals. For biopharmaceuticals ,China has not yet formulated systematic and specific implementation rules and guidelines ,and there is still lack in post-marketing risk management. It is suggested that China can learn from the measures and system of post-marketing risk management of biopharmaceuticals in the United States ,involve stakeholders in post-marketing management ,enhance patients ’awareness of drug use risks through effective communication,and further improve the post-marketing research management system to guarantee patients ’safety of drug use.
期刊: 2021年第32卷第07期
编辑: 李梦颖,王峻霞,蒋蓉
AUTHORS: LI Mengying ,WANG Junxia ,JIANG Rong
关键字: 美国;生物药;上市后风险管理;启示
KEYWORDS: United States ;Biopharmaceuticals;Post-marketing ri sk management ;Enlightenment
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