浅析日本药物警戒体系及其启示

Introduction of pharmacovigilance in Japan and the enlightment to China

本文从国际人用药品注册技术协调委员会创始成员国—日本的组织机构与职责、法律法规体系、上市后药品风险的科学管理评估方法等方面,阐述和分析了药物警戒在日本整体药物安全监管体系中的地位和现状。日本有一套完整、先进的监管理念,借鉴日本已发展演化多年的药物警戒体系,从我国的药物警戒数据库建设、药品风险管理理念引入、流行病方法学研究等诸多方面入手,逐步完善药品安全监管工作。对我国的药物警戒监管工作而言,有重要的研究意义。

The status and situation of pharmacovigilance in Japan’s overall drug safety regulatory system is elaborated and analysed from the aspects of Japan’s organization and responsibility,laws and regulations,post-marketing scientific regulatory management evaluation method in Japan,as the founding member of ICH.Japan has established a fully mature pharmacovigilance system now.The relevant experience of Japan can be learned by China involving the construction of pharmacovigilance system and drug risk management concept,epidemiological methodology research etc.It has a profound meaning for China pharmacovigilance supervision.