美国FDA制定的动物(效应)法规“Animal Rule”

Definition of Animal Rule approved by FDA

9.11恐怖袭击和炭疽邮件事件之后,为提升人类对战争和突发灾难的应变能力,加快军用和重大疫情防治药物的审批,美国食品药品监督管理局(FDA)制定了依据动物效应审批药物上市的动物(效应)法规"Ani-mal Rule",此法规主要适用于治疗或预防危及生命类的、因伦理道德或不可操作性等原因无法获得人临床数据的新药和新生物制品的审批和注册。本文就动物(效应)法规的产生背景、内容和应用概况作一综述。

The Food and Drug Administration （FDA） formulated a new government policy, known simply as the ＂Animal Rule＂, that exempts some drugs from being animal tested for efficacy on humans. This was to improve the ability of protection humans from war and terrorist attacks, and accelerate the speed of drug approval after the 11 September terrorist attacks and the anthrax-filled letters that followed. This rule was designed to permit approval or licensing of drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions based on evidence of effectiveness from appropriate animal studies when human efficacy studies are not ethical or feasible. In this article, we will explore the background legislated,clause and application of the Animal Rule.