The European Medicines Agency’s 2025 concept paper on mechanistic models for Model-Informed Drug Development (EMA/5875/2025) represents a significant milestone in regulatory science. It provides much-needed guidance for assessing and reporting mechanistic models, and for emerging mechanistic types, with emphasis on risk assessment, uncertainty quantification, and regulatory credibility.
At InSilicoMinds, our work in AI, modeling and simulation is aligned with EMA’s goals: enhancing model credibility through best practices, ensuring transparency in model assumptions, and enabling robust decision-making in pharma and life sciences.
Key areas we see as critical:
• Expanding scope beyond traditional models to include agent-based, multi-physics, and multi-scale mechanistic modeling.
• Strong emphasis on Uncertainty Quantification (UQ) and how different sources of evidence can be integrated.
• Use of virtual populations and digital twins to support regulatory submissions for diverse patient groups.
The future where mechanistic modelling is central in regulatory dossiers is closer than ever, and the EU can lead globally in this transformation.
The concept paper (EMA/5875/2025) is available on the EMA website.
