EMA launches pilot for model-informed drug development scientific advice
The European Medicines Agency (EMA) has introduced a dedicated pilot procedure for scientific advice and protocol assistance on model-informed drug development (MIDD) — a significant step forward for the in silico community and a clear regulatory signal that quantitative modelling evidence is coming of age.
EMA is running a pilot procedure providing scientific advice and protocol assistance on model‑informed drug development (MIDD).
Model‑informed drug development refers to the use of quantitative modelling and simulation approaches to generate evidence informing drug development and regulatory decisions. These approaches integrate non-clinical data, clinical data, and prior knowledge such as drug- and disease-specific information.
The pilot is intended for drug development programmes in which MIDD evidence is expected to play a key role in regulatory decision-making.
It enables in-depth interaction between drug developers and regulators for development programmes with a high model impact.
The pilot aims to achieve the following:
- Facilitate expert-to-expert scientific dialogue
- Carry out multidisciplinary communication
- Promote regulatory learning
- Support consistent assessment of MIDD evidence across therapeutic areas
- Support the implementation of the ICH M15 model‑informed development guideline
EMA assesses pilot eligibility based on the following criteria, as described in ICH M15:
- Question of interest
- Context of use
- Expected model impact
Pilot applicants must follow EMA’s guidance on requesting scientific advice or protocol assistance.
For more information, see:
