美国药品加速批准程序对我国药品监管的启示

Overview of accelerated approval by US FDA and some reference points for China

本文通过回顾FDA对临床急需的药品实施加速批准以及上市后进行确证性试验的25年经验,梳理了FDA对药品加速批准的政策法规及上市后要求和承诺。结合我国颁布更新的《药品注册管理办法》中药品加快上市注册程序的相关内容进行讨论,以期对我国建立和完善加快新药上市的政策和途径,以及研发企业对此的实践运用提供参考。

This article mainly introduces the accelerated approval, postmarketing requirements and commitments of drugs for urgent clinical use by US FDA, with the experience of accelerated approval in recent 25 years. Based on the upcoming performance of Drug Registration Regulation, our discussion about these system and experience can provide references for NMPA in formulating policy for accelerated marketing approval of drugs and sponsors in application of these regulations and guidances.