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突破性药物认定是新增的加速审批程序,其作为《美国食品药品管理局安全和创新法案》(FDASIA)的一部分,于2012年7月签署成为法律。美国在20多年前就设置了加速新药上市的特别审批通道,包括优先审评、加速审批和快速通道。而突破性药物认定与上述审批通道的差异在于,只要早期临床数据能够证明在严重或致死疾病的治疗方面与现有药物相比具有实质性改进,即可获得上市批准。一些药物在研发早期即表现出非常显著的活性,而该程序的目的正是加快这些药物的审批进程。
Breakthroughs are identified as a new accelerated approval process that was signed into law in July 2012 as part of the FDA's Safety and Innovation Act (FDASIA). More than 20 years ago, the United States set up special approval channels to speed up the listing of new drugs, including prioritization, accelerated examination and approval and fast track access. The difference between the breakthrough drug approval and the above approval channel is that the market approval is obtained as long as early clinical data can prove that there is a substantial improvement over the existing drugs in the treatment of serious or fatal diseases. Some drugs show very significant activity early in development and the purpose of this procedure is to speed up the approval process for these drugs.