EMA launches Pre-Submission Interactions pilot to improve MAA readiness
The European Medicines Agency (EMA) has initiated a voluntary pilot testing a revised model for Pre-Submission Interactions (PSI) ahead of initial Marketing Authorisation Applications (MAAs).
The new model introduces earlier and more structured dialogue between applicants, EMA and regulatory rapporteurs ahead of a formal submission. A key focus will be assessing whether an application is sufficiently mature and ready to enter the centralised assessment process.
Under the pilot, applicants will engage in written pre-submission discussions at least five months before filing, followed by a joint EU Submission, Timelines and Review Talk (EUSTART) meeting at least three months before submission. Applicants will then confirm the planned submission date through a Letter of Intent.
The initiative is intended to help identify potential issues with dossier maturity earlier and reduce the risk of delays linked to incomplete or insufficiently developed applications.
Participation is voluntary and applies to applications planned for submission between February 2027 and September 2028. EMA will monitor the pilot’s impact on submission timelines, predictability and the overall effectiveness of pre-submission interactions. The results will help inform whether the revised approach should become part of EMA’s longer-term regulatory framework.
Full information here
