美國食品藥品監(jiān)督管理局（FDA）于2017年探索建立了新的仿制藥質(zhì)量評價系統(tǒng)——知識輔助評價和結(jié)構(gòu)化申請（KASA），使用標(biāo)準(zhǔn)格式、通用詞匯和統(tǒng)一輸出，將藥品申請的評價從非結(jié)構(gòu)化文本轉(zhuǎn)變?yōu)榛趩栴}的監(jiān)管和技術(shù)評價，從而提高監(jiān)管決策的一致性和客觀性。對KASA的組成、作用和開發(fā)進(jìn)展進(jìn)行介紹，以期為中國現(xiàn)代化仿制藥審評體系建設(shè)提供參考，促進(jìn)我國藥品審評的現(xiàn)代化及智能化水平提升。

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.

R951