[关键词]
[摘要]
美国食品药品监督管理局(FDA)于2017年探索建立了新的仿制药质量评价系统——知识辅助评价和结构化申请(KASA),使用标准格式、通用词汇和统一输出,将药品申请的评价从非结构化文本转变为基于问题的监管和技术评价,从而提高监管决策的一致性和客观性。对KASA的组成、作用和开发进展进行介绍,以期为中国现代化仿制药审评体系建设提供参考,促进我国药品审评的现代化及智能化水平提升。
[Key word]
[Abstract]
United States Food and Drug Administration (FDA) began to explore and establish a new pharmaceutical quality assessment system for generic drugs in 2017, which is called Knowledge Aided Assessment and Structured Application (KASA). KASA uses standard formats, common vocabulary, and unified output to transform the assessment of drug applications from unstructured text to problem based regulatory and technical assessment, thereby improving the consistency and objectivity of regulatory decisions. This article introduces the composition, role, and development progress of KASA, in order to provide reference for the construction of China's modern generic drug assessment system and promote the modernization and intelligence level of drug assessment in China.
[中图分类号]
R951
[基金项目]