ABSTRACT Model‐informed drug development (MIDD) has emerged as a cornerstone paradigm in global pharmaceutical innovation. Historically underutilized in China, MIDD methodologies gained momentum following the National Medical Products Administration's (NMPA) 2020 release of the Model‐Informed Drug Development Technical Guideline, which was subsequently augmented by supplementary technical guidelines to systematically promote and institutionalize MIDD adoption. This study conducts a longitudinal analysis of MIDD implementation in China‐approved innovative drugs from 2018 to 2024, spanning pre‐ and post‐guideline eras.
Li et al. (Sun,) studied this question.