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

CPT Pharmacometrics & Systems Pharmacology 2026 Open access

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Authors: Jian Li, Zhenlei Wang, Chunmin Wei, Ruirui He, Qingyu Yao
DOI: 10.1002/psp4.70211
Cited by: 1
References: 6

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.

Fields of Study & Subjects

Health Systems Economic Evaluations Quality of Life Biomedical Ethics and Regulation Advanced Causal Inference Techniques

Publication details

Journal / source
CPT Pharmacometrics & Systems Pharmacology
Publisher
Wiley
Volume
15
Issue
2
Pages
e70211–e70211
Publication date
1 February 2026
Language
EN