EMA: adoption of ICH M15 (Step 5)

This milestone marks a significant advancement for Model-Informed Drug Development (MIDD), supporting more consistent planning, evaluation, and communication of quantitative evidence across regulatory agencies.

The ICH M15 Guideline on General Principles for Model-Informed Drug Development has been formally adopted by EMA, with a legal effective date of 23 July 2026 in Europe. The guideline provides structured recommendations for the use of modelling and simulation in regulatory contexts, including approaches for evidence assessment, model evaluation, and MIDD reporting within submissions.

In parallel, the ICH M15 Expert Working Group is developing dedicated training materials to support implementation of the guideline. These modules will cover the core principles, objectives, and scope of ICH M15, as well as key methodological components such as the framework for assessing MIDD evidence, model evaluation strategies, and structured reporting and submission practices. Additional supporting materials, including practical examples using the assessment table, will also be provided.

Key Resources

• EMA final adopted guideline: LINK – ICH M15 Guideline on General Principles for Model-Informed Drug Development (Step 5)
• ICH M15 Guideline and documents: LINK
• ICH M15 Step 4 presentation: LINK