ICH M15 guideline on general principles for model-informed drug development - Step 2b - Scientific guideline

This guideline defines an harmonised framework for evaluating MIDD evidence and provides recommendations for related planning and regulatory interactions, implementation, reporting, and submission.

In the rapidly evolving landscape of drug development, model-informed drug development (MIDD) evidence is playing an increasingly crucial role in guiding decisions made by drug developers, regulatory authorities, and other key stakeholders. 

To streamline the assessment of this valuable evidence, a new guideline has been introduced to facilitate a comprehensive, multidisciplinary approach. 

Keywords: MIDD evidence assessment, modelling and simulation, model risk assessment, model impact assessment, model analysis planning, Model analysis reporting

Current version

Overview of comments received on ICH M15 Guideline on general principles for model informed drug development (EMA/CHMP/ICH/496426/2024)

Reference Number: EMA/91404/2025

Draft ICH M15 Guideline on general principles for model-informed drug development - Step 2b

Draft: consultation closedConsultation dates: 29/11/2024 to 28/02/2025Reference Number: EMA/CHMP/ICH/496426/2024Summary:

This guideline defines an harmonised framework for evaluating MIDD evidence and provides recommendations for related planning and regulatory interactions, implementation, reporting, and submission.

In the rapidly evolving landscape of drug development, model-informed drug development (MIDD) evidence is playing an increasingly crucial role in guiding decisions made by drug developers, regulatory authorities, and other key stakeholders.

To streamline the assessment of this valuable evidence, a new guideline has been introduced to facilitate a comprehensive, multidisciplinary approach. 

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