Ezaki Asami, Hori Akiko
Pharmaceuticals and Medical Devices Agency, Office of Safety II, Office of New Drug V., Chiyoda-ku, Tokyo, Japan.
Gan To Kagaku Ryoho. 2013 Mar;40(3):279-84.
The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.
《风险管理计划（RMP）指南》于2012年4月由厚生劳动省发布。该风险管理计划由安全性规范、药物警戒计划和风险最小化行动计划组成。在本文中，我们以一些抗癌药物为例，概述了药品和医疗器械综合机构的上市后药品安全操作以及风险管理计划。
