日本非处方药审批管理政策的研究及启示

Study and Enlightenment to China of Approval Management Policy of Over-The-Counter Drugs in Japan

近年来,日本非处方药审批管理政策一直以扩大非处方药的可及性,引导公众实现"负责任的自我药疗"为核心目标。日本非处方药可分为第1类医药品、第2类医药品、第3类医药品以及要指导用医药品4类。要指导用医药品为2014新增的药品分类,主要包括新转换的药品,仅允许在药师指导下销售。非处方药注册有单独的注册渠道,注册申请可细化为8类。前7类注册申请由厚生劳动省(MHLW)负责审批,药品和医疗器械局(PMDA)负责技术审批审评工作,标准审评时间为7个月左右。对于第8类符合《非处方药生产和销售审查基准》药品注册申请由47个都道府县实行快速审评审批,标准审评时间为2~3个月。此外,在2015年,日本通过允许多种主体提出药品转换申请来促进非处方药转换。建议我国借鉴日本的经验,通过设置单独的非处方药注册渠道、扩大药品转换申请人资格以及加强对非处方药的使用风险监控等措施引导公众实施负责任的自我药疗。

In recent years, the core goal of Japan’s OTC approval management policy has been to expand the accessibility of OTC drugs and guide the public to achieve "responsible self medication". Japan’s OTC drugs can be divided into 4 categories: Category 1,category 2, category 3 and those to be used for guidance. To guide the use of pharmaceutical products for the new drug classification in 2014, the newly converted drugs were mainly included, which only allowed to be sold under the guidance of pharmacists. There are separate registration channels for OTC drug registration, and registration applications can be divided into 8 categories. MHLW is responsible for the approval of the first 7 types of registration applications, and PMDA is responsible for the technical approval and review. The standard review time is about 7 months. For the 8 th category drugs that are in line with drug registration application of Production and Sale of OTC Drugs, 47 prefectures and counties will conduct rapid review and approval, the standard review time is2-3 months. In addition, in 2015, Japan promoted OTC drug conversion by allowing multiple entities to apply for drug conversion.It is suggested that China should use the experience of Japan for reference to guide the public to implement responsible self medication by setting up a separate registration channel for OTC drugs, expanding the qualification of drug conversion applicants and strengthening the risk monitoring of OTC drug use.