Regulatory Blog

Preparing a marketing authorisation application (MAA) requires early planning, clear communication, and a sufficiently mature dossier. To strengthen this process, the European Medicines Agency (EMA) has introduced a revised Guidance on the "Pre-Submission Interactions (PSI) model" as part of a voluntary pilot phase. The revised model aims to encourage earlier and more comprehensive dialogue between applicants, rapporteurs, and EMA. It focuses on improving submission readiness