Beginning in September 2026, the European Medicines Agency (EMA) has invited marketing authorisation applicants to participate in an 18-month pre-submission interactions (PSI) model pilot.
The core objectives of this pilot are to improve submission readiness and support more predictable assessment timelines. This will be facilitated by the introduction of earlier and more structured conversations between sponsors, rapporteurs and the EMA.
Participation in the pilot is voluntary and is open to applicants planning to submit an initial marketing authorisation application between February 2027 and September 2028. According to plans, the EMA will contact applications with an initial marketing authorisation submission scheduled from February 2027 onwards. However, applicants can be proactive and reach out to the EMA to express their interest in the pilot.
As with the standard marketing authorisation application process, an eligibility request should be submitted 18 months before the intended submission date. This is followed by a request for rapporteur allocation at nine months before the intended submission. At least five months prior to submission, written PSIs with the EMA will occur. This is followed by a joint pre-submission meeting (EU submission, timelines and review talk (EUSTART)) at least three months before submission. At this meeting, the application, rapporteur(s) and the EMA will discuss dossier maturity and confirm submission readiness.
Further details of the programme can be found here.
Colleagues at the European Medicines Agency will be attending the TOPRA Symposium 2026 on 19-21 October in Utrecht. Join us to be part of the debate.
