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MIDD Evidence to Support Drug Regulatory Decisions in China
Lili Gao1, Yan Wang1, Ruirui He1
1Center for Drug Evaluation, National Medical Products Administration, China.
Clinical and Translational Science
|July 10, 2026
Summary
Model-Informed Drug Development (MIDD) guidelines from China's CDE are crucial for innovative drug development. Addressing challenges in data quality and validation will shift China
Area of Science:
- Pharmacometrics and Drug Development
- Regulatory Science
Background:
- China's Center for Drug Evaluation (CDE) has issued technical guidelines for Model-Informed Drug Development (MIDD).
- MIDD guidelines cover quantitative pharmacology models across the drug development lifecycle, including dose optimization, pediatric extrapolation, rare disease drug development, and exposure-response (E-R) research.
Purpose of the Study:
- To systematically review CDE's MIDD guidelines.
- To analyze innovative drug development cases in China and internationally.
- To evaluate MIDD's role in supporting drug development and regulatory decisions.
Main Methods:
- Systematic review of CDE technical guidelines for MIDD.
- Analysis of typical application cases of innovative drugs approved in China and internationally.
- Evaluation of MIDD's impact on drug development efficiency and clinical trial burden.
Main Results:
- MIDD has been successfully applied to optimize dosing regimens, construct evidence for pediatric and rare disease drug development, support dosage adjustments in special populations, and characterize complex in vivo processes.
- MIDD enhances R&D efficiency and reduces clinical trial burdens.
- Current challenges in China's MIDD field include data quality, prospective design, and validation standards.
Conclusions:
- Strengthening data collection, model validation, and lifecycle management is essential.
- Promoting a shift from model-assisted to model-driven drug development is necessary.
- This shift will accelerate the global market entry of Chinese innovative drugs.
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