Insights

EMA has launched a new pilot procedure dedicated to Model-Informed Drug Development (MIDD) scientific advice and protocol assistance. The initiative is intended for development programs where modeling and simulation evidence is expected to have a significant impact on regulatory decision-making.

The pilot is closely linked to the implementation of the new ICH M15 Guideline on General Principles for Model-Informed Drug Development, which establishes a harmonized framework for the assessment and acceptance of MIDD evidence by regulators. The guideline emphasizes the importance of early interaction with regulatory authorities to ensure that modeling strategies, data generation plans, and evidentiary expectations are aligned from the beginning of development.

Under the pilot, applicants can engage in in-depth discussions with EMA experts on key aspects of their MIDD strategy, including the question of interest, context of use, model impact, model risk, and evidence-generation plans. Applications should include the MIDD assessment table and, where available, supporting Model Analysis Plans (MAPs) and Model Analysis Reports (MARs).

This initiative represents an important opportunity for sponsors seeking regulatory feedback on innovative modeling approaches and may facilitate the acceptance of MIDD evidence in future regulatory submissions.

Regulatory Pharma Net (RPN) supports companies throughout the drug development pathway, including regulatory planning and early dialogue with authorities. In this context, RPN can assist sponsors in preparing for MIDD scientific advice and protocol assistance procedures and in aligning model-informed approaches with ICH M15 principles and EMA expectations.