ICH M15 is redefining expectations for Model-Informed Drug Development (MIDD).
The draft ICH M15 guideline introduces a globally harmonized framework for evaluating model credibility, clarifying context of use, and strengthening how modeling evidence is planned, communicated, and justified in regulatory decision-making.
Regulatory agencies including the FDA and EMA are already applying elements of the ICH M15 framework in regulatory interactions. That means sponsors cannot afford to wait for final adoption—MIDD strategies must align with evolving credibility standards today.
This guide helps clinical pharmacology, pharmacometrics, and regulatory teams assess their readiness and strengthen internal alignment across disciplines.
In this guide, you will learn:
- How to apply the ICH M15 model credibility framework using a structured, risk-based approach
- What “context of use,” “model impact,” and “totality of evidence” mean in practice
- How to evaluate model risk collaboratively across pharmacometrics, clinical, regulatory, and toxicology teams
- Why early regulatory engagement is critical for successful MIDD implementation
- How global harmonization across FDA, EMA, PMDA, and other agencies impacts development strategy
- Real-world use cases where MIDD influences dose selection, pediatric extrapolation, PBPK-based DDI waivers, exposure-response analysis, and virtual bioequivalence
- ICH M15 reflects a broader shift: modeling is no longer a supportive technical activity—it is a structured decision-support discipline central to modern regulatory strategy.
Download the guide to evaluate your organization’s ICH M15 readiness and ensure your MIDD framework is credible, transparent, and globally aligned.
