美国FDA“动物(效应)法规”在生物防御药物开发中的应用及启示  

Application and Implications of U.S.FDA"Animal Rule"in the Biodefence Drug Development

作　　者：王伯阳 高锦 王子东[1] 李杰[1] Wang Boyang;Gao Jin;Wang Zidong;Li Jie(General Station for Drug&Instrument Supervision and Control Joint Logistic Support Force,Chinese People’s Liberation Army,Beijing 100071,China)

机构地区：[1]中国人民解放军联勤保障部队药品仪器监督检验总站,北京100071

出　　处：《中国药事》2020年第6期636-643,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:在应对重大公共卫生事件中,为我国相关生物防御药物的上市审批和应用储备提供参考依据和解决思路。方法:结合审批实例,对美国FDA"动物(效应)法规"的主要内容、应用范围和实施状况进行综述,针对美国和我国现阶段应对重大公共卫生事件的药品审批机制进行讨论。结果与结论:在针对可能发生的生物恐怖袭击事件及重大疫情开展的药物研发中,评价尺度可以与普通药物有所区别,应视情做好相应生物防御药物的战略储备,为应对突发重大公共卫生事件提供系统性支持。Objective:To provide reference and solution for approving new drugs and reserves for the bio-defence in tackling major public health emergencies.Methods:Combine with the approval instance,the article summarizes the main content,application scope and implementation status of U.S.FDA"animal rule",and discusses the drug approval mechanism in the United States and China in response to major public health emergencies.Results and Conclusions:In drug research and development for possible bioterrorism attacks and major epidemics,the evaluation scale could be different from that of common drugs,a strategic reserve of drugs for the bio-defence should be established to provide systematic support for responding to major public health emergencies.

关 键 词：动物(效应)法规 药物 生物防御 

分 类 号：R95[医药卫生—药学]