欧美政府和企业应对抗生素耐药战略决策和行动计划概述  

Overview of the Policy and Action by US/European Government and Industry to Combat Antibiotics Resistance

作　　者：卢亮 袁征宇 赵明[2] 张菁 Lu Liang;Yuan Zheng-yu;Zhao Ming;Zhang Jing(MicuRx Pharmaceuticals Inc,Shanghai 201203;Center for Drug Evaluation, National Medical Products Administration, Beijing 100038;Institute of Antibiotics, Huashan Hospital affiliated to Fudan University, Shanghai 200040)

机构地区：[1]上海盟科药业有限公司,上海201203 [2]国家药品监督管理局药品审评中心,北京100038 [3]复旦大学附属华山医院抗生素研究所,上海200040

出　　处：《国外医药（抗生素分册）》2019年第2期87-91,共5页World Notes on Antibiotics

基　　金：国家科技重大专项重大新药创制(2017ZX09304005)

摘　　要：抗生素耐药已成为威胁人类健康的全球性问题。作为抗生素行业的领导者,欧美政府部门和制药公司已积极行动起来,讨论并发布了一系列应对抗生素耐药的改革意见和方案。本文对其近期出台的相关指南和指导性文件进行简要解读,为我国抗生素研发行业改革提供参考。Antibiotic resistance has become a global threat to human health. As the leaders of the antibiotic industry, the European and US government and the pharmaceutical industry alliances have taken positive actions and issued a series of reforms and action plans to combat the antibiotics resistance. This paper gives a brief interpretation of these recently published documents and provides valuable suggestions for domestic antibiotic industry refbnn.

关 键 词：抗生素耐药 QIDP 新型抗生素 合理使用 

分 类 号：R978.1[医药卫生—药品]