EMA - public consultation the ICH M15 Guideline on general principles for model-informed drug development

11th December 2024

EMA

The European Medicines Agency has published for public consultation the ICH M15 Guideline on general principles for model-informed drug development.

This guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD). It establishes a harmonised assessment framework (including associated terminology) for MIDD evidence. It applies to both current and emerging modeling and simulation (M&S) methods and applications. It focuses on assessment of MIDD evidence and provides recommendations for related regulatory interactions, reporting, and submission. This guideline is intended to facilitate a multidisciplinary understanding of MIDD and associated evidence generation.

Comments should be provided using this template and sent to ich@ema.europa.eu by 28 February 2025.

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