美國(guó)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(píng)價(jià)系統(tǒng)——知識(shí)輔助評(píng)價(jià)和結(jié)構(gòu)化申請(qǐng)（KASA），使用標(biāo)準(zhǔn)格式、通用詞匯和統(tǒng)一輸出，將藥品申請(qǐng)的評(píng)價(jià)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(píng)價(jià)，從而提高監(jiān)管決策的一致性和客觀性。對(duì)KASA的組成、作用和開發(fā)進(jìn)展進(jìn)行介紹，以期為中國(guó)現(xiàn)代化仿制藥審評(píng)體系建設(shè)提供參考，促進(jìn)我國(guó)藥品審評(píng)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.

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