Practical implication
Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.
The EMA is undertaking a pilot that will introduce a revised framework for pre-submission interactions with the aim of optimizing submission readiness and reducing the occurrence of ‘premature’ applications. The pilot will enhance communication between applicants and the EMA, involving structured timelines and responsibilities in the marketing authorisation application process.
What changed: A revised model for pre-submission interactions is now being piloted. This includes structured timelines for application submissions, with specific advance notice requirements for requesting rapporteurs and the submission of key documents.
Why it matters: This pilot offers a new approach to regulatory interactions that could lead to smoother application assessments, potentially decreasing delays and improving submission quality for future marketing authorisation applications.
Practical implication: Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.
View original source
- Source: EMA - What's new
- Published at source: 2026-09-02T10:00:00.000Z
- Discovered by monitor: 2026-09-02T21:45:26.867Z
Published from the regulator source ingestion pipeline after PV impact triage.
