The EMA is inviting marketing authorisation applicants to take part in an 18-month pre-submission interactions (PSI) model pilot.
When did EMA launch the pilot?
The pilot was launched in September 2026
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.
What is purpose of the pilot and what are its objectives?
The pilot aims to achieve the following:
- Optimise submission readiness
- Identify “premature” applications and assessment issues at an early stage
- Support alignment between the following on realistic submission timelines:
- applicants,
- rapporteurs and
- EMA
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 morecomprehensive dialogue between all parties involved in the procedure.
When will the pilot open be open applicants planning an initial marketing authorisation?
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.
Is participation in the pilot voluntary?
Yes, participation is voluntary: applicants, rapporteurs and EMA agree together on which applications to include in the pilot.
What happens once an initial marketing authorisation application is included 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).
When will the EMA contact applicants?
The EMA will contact applicants with an initial marketing authorisation submission scheduled from February 2027 onwards.
Can applicants be pro-active and express their interest even before being contacted?
Yes, 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).
Does the pilot build on the existing pre-authorisation process?
Yes it does.
The pilot tests a revised pre-submission interactions (PSI) model (see model timeline below) that builds on the existing pre-authorisation process.
It adds so-called structured touchpoints between rapporteurs’ appointment and marketing authorisation submission.
What is the timeline of the revised Pre-submissions interaction (PSI) model?
The timeline below provides a summary of the revised model.
| Event | Time BEFORE the intended marketing authoriation submision date | Notes |
|---|---|---|
| Eligibility request | 18 months before | Unchanged by revised model. |
| Request for rapporteur allocation | At least 5 months before | The revised EMA pre-submission interactions (PSI) form enables a written exchange with EMA. EMA provides written feedback within 3 weeks of a complete submission. |
| Joint pre-submission meeting (EUSTART) | At least 3 months before | 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 | This is to confirm the agreed submission date |
Is there guidance and other supporting documentation available to guide applicants through the pre-submission interactions pilot.
Yes there is.
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:
| Document | Brief indication of what each document contains and how it should be used in the pilot: |
|---|---|
| Guidance on the revised pre-submission interactions (PSI) model | full process description and expectations for applicants, rapporteurs and EMA |
| Revised EMA pre-submission interactions (PSI) form | to be completed electronically and submitted via the IRIS portal, together with the required background documents |
| EUSTART (EU Submission, Timelines and Review Talk) | document to help applicants prepare for the joint pre-submission meeting and structure their briefing package |
| Annex to the request for rapporteurship | development status overview to accompany the request for rapporteur allocation |
Next steps
EMA will monitor the pilot’s progress against a defined set of key performance indicators (KPIs) covering the following aspects:
- Effectiveness of the revised PSI model
- Submission timeline alignment and predictability
- Process timelines
EMA plans to produce a report evaluating the pilot’s impact.
Future refinements are possible based on pilot findings.
Source: EMA