EU Opened Optional eCTD v4.0 Submissions for Centralised Applications in December 2025

In a go-live announcement dated 15 December 2025, EMA stated that applicants could optionally submit new marketing authorisation applications in the centralised procedure using eCTD v4.0 from 22 December 2025. The announcement asked applicants to contact EMA’s eCTD v4.0 team before any v4.0 submission, so that the agency could prepare for each case during the first phase of use. eCTD v3.2.2 remains accepted in parallel, and applicants can continue to use it for new and existing products.

The EU approach starts with new applications only. A product authorised through a v4.0 application will have its lifecycle in v4.0 from the outset, while products whose dossiers were built in v3.2.2 remain in that format for now. A later EMA presentation on digitalisation initiatives states that the timetable for moving existing v3.2.2 lifecycles to v4.0 depends on testing and readiness assessments, and that a new end-to-end testing phase was under way, with marketing authorisation holders invited to send v4.0 test submissions.

EMA has supported the launch with an EU eCTD v4.0 practical guidance document and EU-specific validation criteria. An eSubmission news item dated 8 July 2026 announced updated validation criteria applicable from 15 July 2026. Secondary sources identify these as version 1.1 of the EU eCTD v4.0 validation criteria.

EMA’s own material indicates that mandatory use of eCTD v4.0 for centralised applications is not expected before late 2027, subject to testing and readiness checks. Several consultancy and vendor sources describing the updated EU roadmap report that EMA strongly recommends v4.0 for new centralised applications from Q1 2027 and plans to make it mandatory for new centralised applications from Q1 2028. Earlier publications had given 2026 or 2027 as the mandatory year, and EMA’s timeline documents note that the dates are subject to revision.

Sources also differ on forward compatibility, which would allow an application started in v3.2.2 to continue in v4.0. Some report a forward-compatibility pilot for centrally authorised products from Q4 2026, while others describe a pilot running since March 2026. Because these dates were not confirmed in an EMA primary document seen for this brief, applicants should treat them as provisional and check the eSubmission eCTD v4.0 project page for the current plan.

Mutual recognition, decentralised and national procedures are on separate timelines set through the Heads of Medicines Agencies eSubmission roadmap. An older timeline table listed the dates for those procedures as to be confirmed.

IRIS is EMA’s online platform for managing regulatory procedures. It is separate from eCTD v4.0, which is a dossier format, but the two developments together change how applicants interact with the agency. EMA guidance states that from January 2025 marketing authorisation holders should use IRIS when managing renewals and annual re-assessments, and other post-authorisation procedures were moved over on a similar timetable.

An EMA industry platform presentation from October 2025 listed initial marketing authorisation applications for human and veterinary medicines among the procedures planned for 2026, with the aim of completing the migration of all SIAMED processes to IRIS by mid-2026. An EMA IRIS notice described the transition of initial marketing authorisation application procedures as a focus for the year. Trade reports state that EMA revised its IRIS Guide for Applicants on 15 June 2026 and added further functions from 18 August 2026. A confirmed date from which IRIS became mandatory for initial applications was not found in the sources reviewed for this brief.

EMA has stated that IRIS does not replace the eSubmission Gateway. The two coexist, each with specific functions, and dossier transmission through the Gateway continues.

For applicants planning a centralised application in 2026 or 2027, the immediate choice is whether to file in v4.0 voluntarily. Filing in v4.0 gives early experience and avoids a later lifecycle migration for that product, but requires prior contact with EMA, publishing software that supports EU eCTD v4.0, and conformance with the validation criteria applicable from 15 July 2026. Filing in v3.2.2 remains fully acceptable.

Regulatory operations teams should also prepare for IRIS as the route for procedure-related interactions, including registering the correct users and organisations and following the current IRIS Guide for Applicants. Because EU dates have moved more than once, teams should plan on the basis of EMA’s current published roadmap and treat dates reported by third parties as indicative until EMA confirms them.