药品生命周期管理最新指南介绍与安全性评价的作用浅析  

On the Latest Guideline to Life-cycle Management of Pharmaceutical Products and the Roles of Safety Evaluation

作　　者：张靖[1,2] 李红颖 耿兴超 靳洪涛[1,4] Zhang Jing;Li Hongying;Geng Xmgchao;Jln Hongtao(Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China;Development Center for Medical Science and Technology, National Health and Family Planning Commission of the People＇s Republic of China, Beijing 100044, China;National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 100176, China;Beijing Union-Genius Pharmaceutical Technology Co., Ltd., Beijing 100176, China)

机构地区：[1]中国医学科学院北京协和医学院药物研究所,北京100050 [2]国家卫生计生委医药卫生科技发展研究中心,北京100044 [3]中国食品药品检定研究院国家药物安全评价监测中心,北京100176 [4]北京协和建昊医药技术开发有限责任公司,北京100176

出　　处：《中国药事》2018年第6期770-774,共5页Chinese Pharmaceutical Affairs

基　　金：重大新药创制项目(编号2013ZX09302302;编号2012ZX09301002-001-009)

摘　　要：人用药品注册技术要求国际协调会(International Conference for Harmonization,ICH)于2017年12月颁布了Q12新草案,该草案补充了药品生命周期的管理内容,对药品的安全性评价和风险评估具有重要的指导意义。本文概述了ICH Q12的最新内容和Q12对安全性评价和风险评估的最新要求,总结了安全性评价在药品生命周期管理中的作用及应用现状,以期为保障药品的安全性,促进药品生命周期管理方式发展以及公众合理用药提供参考。The International Conference for Harmonization（ICH） promulgated a new draft Q12 in December 2017, which supplemented the content of the life-cycle management of the pharmaceutical products and provided an important guidance for safety evaluation and risk assessment of drugs. This article summarized the latest contents of ICH Q12 and the latest requirements for safety evaluation and risk assessment, the role and application of safety evaluation in the life-cycle management of the pharmaceutical products so as to provide references for ensuring the safety of drugs, promoting the development of management methods and the rational drug use.

关 键 词：ICH Q12 安全性评价 药品生命周期 

分 类 号：R95[医药卫生—药学]