日本药品上市后风险管理计划研究及对我国的启示

Study on Post-marketing Drug Risk Management Plan in Japan and Its Enlightenment to China

目的:借鉴日本药品上市后风险管理计划(RMP)的经验,为完善我国药品上市后风险管理提供参考。方法:介绍日本药品上市后监管的流程,剖析日本RMP中体现出的国际人用药品注册技术协调会(ICH)指导原则,研究日本RMP在药品上市后安全管理中的制定与应用,对我国药品上市后风险管理的完善方向提出建议。结果与结论:日本药品上市后监管具有动态监管、社会共治的特点。ICH原则贯穿日本RMP管理,日本规定的安全性讨论事项、风险最小化活动等均体现了与ICH原则的内在一致性。日本《药事法》对RMP进行了规定,具体由日本药品、化妆品及医疗器械的上市后安全管理的药物警戒标准(GVP省令)指导制定和实施,由药品上市后调查及试验实施基准的省令(GPSP省令)指导变更。RMP是日本新药上市注册及再审查的必要文件,药企对制定RMP负责,而公众可通过药品和医疗器械综合管理机构(PMDA)订阅媒体系统获取新药RMP,体现了政府-药企-公众多元共治。目前我国RMP监管未成体系且经验不足,缺乏指南文件,信息通信技术应用较少。建议我国加强上市后安全数据管理,推进哨点医院与药企药物警戒系统相衔接,增加信息通信技术的应用。国家药品监督管理局应出台相关规范性文件和RMP指南,明确药品上市后监管体系,以推行RMP公开为契机,促进药品风险管理社会共治,实现阳光监管、科学监管。

OBJECTIVE:To provide reference for improving the post-marketing drug risk management in China by refering to the experience of post-marketing drug risk management plan(RMP)in Japan.METHODS:The process of post-marketing drug regulation in Japan was introduced,and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)guidelines embodied in RMP in Japan were analyzed.The formulation and application of RMP in Japan during the post-marketing safety management were studied.And suggestions were offered for the improvement of post-marketing drug risk management in China.RESULTS&CONCLUSIONS:The post-marketing regulation of drugs in Japan is characterized with dynamic regulation and social co-governance.ICH principle runs through the RMP management in Japan.Safety specification and risk minimization activities stipulated in RMP in Japan are consistent with ICH guidelines.RMP is defined in Pharmaceutical Affairs Law in Japan,and is formulated and implemented under the guidance of the Good Vigilance Practice;the changes are made under the guidance of the Good Post-marketing Study Practice.RMP is a necessary document for the registration and the re-review of new drugs in Japan,its formulation is responsible by pharmaceutical enterprise;RMP of new drug is available to the public through the subscription media system of Pharmaceuticals and Medical Devices Agency(PMDA),which reflects the multi-governance of the government-pharmaceutical enterprises-the public.In China,RMP supervision is not systematic and is inexperienced,and there is a lack of guidance documents and insufficient application of information and communication technology.It is suggested that China should strengthen post-marketing safety data management,promote the connection between sentinel hospitals and pharmacovigilance systems of pharmaceutical enterprise,increase the application of information and communication technology.Relevant normative documents and guidance documents of RMP should be issued by National Medical Products Administration.And the post-marketing supervision system for drugs should be clarified.Taking RMP publicity as an opportunity promote drug risk mamagement co-government,realize sunshine and scientific supervision.