EMA is inviting marketing authorisation applicants to take part in an 18-month pre-submission interactions (PSI) model pilot.
The pilot introduces an earlier, more structured dialogue between applicants, rapporteurs and EMA.
It aims to improve submission readiness and support more predictable assessment timelines.
EMA launched the pilot in September 2026.
To learn more about EMA's pre-authorisation guidance, see:
The pre-submission interactions (PSI) model pilot introduces shared ownership and early dialogue between applicants, rapporteurs and EMA over the submission timing.
This gives all parties better visibility into planning and an opportunity to identify potential issues together before the formal application submission.
The pilot aims to achieve the following:
It is meant to address cases when applicants submit their marketing authorisation applications before the supporting data package is fully mature. Such cases can lead to delays, clock-stop extensions, or a need for substantial new data submission during assessment. This is why the revised model builds in earlier and more comprehensive dialogue between all parties involved in the procedure.
For more information on pre-submission interactions, see the section on 'Steps prior to submitting the application' - Q&A 2.9.1 on 'How are marketing authorisation application pre-submission interactions structured at EMA? on the 'Pre-auhorisation guidance' page:
The pre-submission interactions (PSI) model pilot is open to applicants planning to submit an initial marketing authorisation application between February 2027 and September 2028.
Participation is voluntary: applicants, rapporteurs and EMA agree together on which applications to include in the pilot.
Once an application is included in the pilot, the applicant, rapporteurs and EMA are expected to follow the agreed process through to submission. This allows the pilot to generate valuable insights measured against key performance indicators (KPIs). Find out about the related KPIs in the 'Next steps' section on this page.
EMA contacts applicants with an initial marketing authorisation submission scheduled from February 2027 onwards.
Applicants can be pro-active and express their interest even before being contacted. They can do so via their EMA product lead.
In this way, applicants can agree on participation with the relevant rapporteurs and EMA, ahead of the applicable milestone(s).
The pilot tests a revised pre-submission interactions (PSI) model that builds on the existing pre-authorisation process.
It adds so-called structured touchpoints between rapporteurs' appointment and marketing authorisation submission.
The timeline below provides a summary of the revised model:
Eligibility request
18 months before the intended initial marketing authorisation submission date
Unchanged by revised model.
Request for rapporteur allocation
9 months before the intended submission date
Submitted together with an up-to-date development status overview.
Pre-submission interactions (written)
5 months before the intended submission date
The revised EMA pre-submission interactions (PSI) form available on this page enables a written exchange with EMA. EMA provides written feedback within 3 weeks of a complete submission.
Joint pre-submission meeting (EUSTART)
3 months before the intended submission date
A joint meeting between the applicant, rapporteur(s) and EMA. This is to discuss dossier maturity and confirm submission readiness. EUSTART stands for EU submission, timelines and review talk.
Letter of intent
2 months before the intended initial marketing authorisation submission date
This is to confirm the agreed submission date.
Supporting documents are available to guide applicants through the pre-submission interactions pilot.
Find below brief indications of what each document contains and how it should be used in the pilot:
EMA is monitoring the pilot's progress against a defined set of key performance indicators (KPIs) covering the following aspects:
EMA plans to produce a report evaluating the pilot's impact.
Future refinements are possible based on pilot findings.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in August 2026.
28 August 2026
Page first published