In September 2026, the European Medicines Agency (EMA) launched the new EU Submission, Timelines and Review Talk (EUSTART). The guidance aims to help applicants prepare for joint pre-submission meetings with EMA, rapporteurs and national competent authorities ahead of marketing authorisation applications (MAAs). The process is designed to identify potential issues early, help avoid insufficiently prepared submissions and support agreement on an appropriate submission timeline.
Who is affected by EMA's EUSTART process?
This update is most relevant to Regulatory Affairs professionals in pharmaceutical and biotechnology companies preparing centralised MAAs in the EU. It is relevant for organisations of all sizes, from SMEs to large pharmaceutical companies, particularly teams responsible for regulatory strategy and submission planning.
Why EUSTART matters for marketing authorisation applications
The guidance is intended to support earlier alignment on dossier readiness, regulatory expectations and submission timing. By facilitating these discussions before submission, it may help reduce the likelihood of clock-stops, minimise avoidable review questions and support more predictable assessment timelines.
What EUSTART means for sponsors preparing an EU MAA
EUSTART gives applicants a structured opportunity to align with EMA, the rapporteurs and national competent authorities before submitting a marketing authorisation application. To make the most of it, we recommend these actions:
- Review upcoming centralised MAAs and consider incorporating EUSTART interactions into regulatory planning activities.
- Use the meetings to align on submission timing, confirm dossier readiness and address potential procedural risks before submission.
- Consider seeking expert regulatory support early in the planning process to develop an effective submission strategy, prepare for authority interactions and maximise the value of pre-submission engagements.
Josephine Ingemarsson
MSc, Senior Consultant Regulatory Affairs
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