The European Medicines Agency (EMA) has moved major pre-submission activities for centrally authorised human medicines into its IRIS platform and linked the new workflow more closely to identification of applications subject to EU Joint Clinical Assessment (JCA). The change brings regulatory and HTA planning together earlier in the development cycle.
From 19 August, applicants must use IRIS to request eligibility for the centralised procedure, submit letters of intent, request accelerated assessment, notify changes, transfers or withdrawals of eligibility, and manage pre-submission interactions. A valid Research Product Identifier (RPI) is required before a new request can be submitted.
EMA will extend the IRIS model on 1 September to management of new initial marketing-authorisation applications for centrally authorised products. Dossier files will continue to pass through the existing eSubmission Gateway, while IRIS becomes the system used to manage the regulatory procedure.
The migration also changes the interface with the EU Health Technology Assessment Regulation (HTA Regulation). EMA's revised pre-authorisation guidance requires applicants, through the IRIS eligibility and intent-to-submit process, to declare whether the planned marketing-authorisation application falls within Article 7 of the Regulation and is therefore subject to JCA.
Where JCA applies, the Member State Coordination Group on Health Technology Assessment (HTACG) advises developers to notify the HTA Secretariat in parallel. Developers should download the IRIS-generated eligibility and intent-to-submit forms and submit them through the HTA IT Platform. This allows JCA pre-submission planning to start alongside the EMA process.
Developers must also keep both processes aligned if the intended submission date changes or an application is withdrawn. A delay can itself alter JCA status as the Regulation expands: cancer medicines with new active substances and advanced therapy medicinal products are already covered, orphan medicines enter scope from January 2028 and other medicines covered by Article 7 follow from January 2030.
The European Commission has supplemented the revised workflow with a JCA eligibility checker, first published on 3 August. The questionnaire gives developers an indicative view of whether a planned application may fall within JCA scope.
The combined changes make IRIS an earlier control point for both centralised regulatory planning and JCA readiness. Regulatory and access teams will need to resolve eligibility, submission timing and HTA scope together, particularly where timetable changes could move a product into a later phase of mandatory JCA coverage.
Source: European Medicines Agency
Link: Presubmission activities now managed through IRIS
Date: 19 August 2026
Source: Directorate-General for Health and Food Safety, European Commission
Link: New eligibility tool and updated guidance for early information for joint clinical assessments
Date: 19 August 2026
Source: European Medicines Agency
Link: Pre-authorisation guidance
Date: 19 August 2026
