ICH M15 is redefining expectations for Model-Informed Drug Development (MIDD).
The finalized ICH M15 guideline establishes 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.
With formal adoption in January 2026, regulatory agencies including the FDA, EMA, PMDA, and others are aligned around a common structure for assessing MIDD. Sponsors can no longer treat model credibility as implicit, it must now be systematically defined, justified, and documented in accordance with ICH M15 expectations.
This guide helps clinical pharmacology, pharmacometrics, and regulatory teams assess their readiness and strengthen internal alignment across disciplines in the new regulatory environment.
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 influence,” and “totality of evidence” mean in practice
- How to evaluate model risk collaboratively across pharmacometrics, clinical, regulatory, and toxicology teams
- Why early and proactive regulatory engagement is critical under the finalized ICH M15 framework
- How global harmonization across FDA, EMA, PMDA, and other agencies impacts development strategy
- Real-world use cases where MIDD informs dose selection, pediatric extrapolation, PBPK-based DDI waivers, exposure-response analysis, and virtual bioequivalence
ICH M15 reflects a structural shift: modeling is no longer a supportive technical activity, it is a formalized, decision-support discipline central to modern regulatory strategy.
Download the guide to evaluate your ICH M15 implementation strategy and position your MIDD framework for regulatory confidence and global consistency.
