Quantitative Evaluation of Model‐Informed Drug Development Implementation in China's Approved Innovative Drugs: From Policy to Practice (2018–2024)

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.