European Union
Regulator EC · EMA (European Commission & European Medicines Agency) Official site ↗
Implementation by procedure
Technical pilot completed in 2024; new MAA CAPs may be submitted voluntarily in v4.0 from 22 December 2025 (prior contact with the EMA eCTD team required); strongly recommended from 2027, mandatory from 2028.
Voluntary/mandatory timing remains TBD under the ICH table; the non-CAP new MAA technical pilot is planned for Q3/Q4 2026.
Voluntary/mandatory timing remains TBD under the ICH table; the non-CAP new MAA technical pilot is planned for Q3/Q4 2026.
Voluntary/mandatory timing remains TBD under the ICH table; the non-CAP new MAA technical pilot is planned for Q3/Q4 2026.
eCTD v4.0
Draft / transitionEU adoption of eCTD v4.0 is driven jointly by the European Commission and EMA. The technical pilot for centralised procedures (CAPs) completed in 2024; per EMA's 15 December 2025 announcement, new MAA CAPs may be submitted voluntarily in v4.0 from 22 December 2025 (prior contact with the EMA eCTD team required). A CAP forward-compatibility pilot (Pilot Phase III) started on 19 March 2026; per the 8 July 2026 update, the next CAP forward-compatibility pilot is planned for Q4 2026 and the non-CAP new MAA technical pilot for Q3/Q4 2026, with the forward-compatibility timetable pending test results. Voluntary/mandatory timing for MRP/DCP/NP remains TBD under the ICH table; new MAA CAPs are strongly recommended from 2027 and mandatory from 2028. Under v4.0 the EU Module 1 is no longer a separate regional XML: it folds into a single backbone and expresses regional concepts through controlled vocabularies.
The EU mandatory date is procedure-dependent: centralised procedures lead, while timings for mutual recognition, decentralised and national procedures are set separately. If your portfolio spans several procedures, plan the switch per procedure.
eCTD v3.2.2 · EU M1
In forceThe EU mandated eCTD for centralised procedures from 1 January 2010, later extending it to mutual recognition, decentralised and national procedures. The regional part is defined by the EU Module 1 specification, currently EU M1 v3.1.1 (published 2 June 2025) with validation criteria v8.2: optional from 1 October 2025 and mandatory from 1 December 2025 — from that date, the EU M1 v3.1 / validation criteria v8.1 combination is no longer accepted.
This is the working baseline for EU filings today. Your publishing toolchain and pre-submission checks must cover EU M1 v3.1.1 plus validation criteria v8.2, or sequences will be stopped at the technical validation gate.
Notices & updates
FAQ
When does the EU make eCTD v4.0 mandatory?
Under the ICH regional implementation table: new MAA CAPs are strongly recommended from 2027 and mandatory from 2028; timings for MRP/DCP/NP and national procedures are set separately. Always defer to EMA's own roadmap.
Can CAPs be submitted in eCTD v4.0 today?
Yes. Per EMA's 15 December 2025 announcement, new MAA CAPs may be submitted voluntarily in v4.0 from 22 December 2025, after contacting the EMA eCTD team in advance; v3.2.2 remains accepted during the voluntary period. Voluntary acceptance for MRP/DCP/NP remains TBD under the ICH table (the non-CAP new MAA technical pilot is planned for Q3/Q4 2026).
What is the current v3.2.2 acceptance baseline?
Since 1 December 2025, new sequences must conform to both EU Module 1 v3.1.1 and validation criteria v8.2; 1 October – 30 November 2025 was a transition window accepting either version, and the EU M1 v3.1 / validation criteria v8.1 combination is no longer accepted.