News
Previous news available Here
08-07-2026
eCTD v4.0 in EU - timeline updated and ongoing pilots
Following the start of optional use for eCTD v4.0 for
new Centrally Authorised Product (CAP) Marketing
Authorisation Applications (MAAs) on 22 December 2025,
regulators and industry continue to focus on testing, pilot activities and
implementation readiness as part of the broader transition to the new
standard. During the transition period, eCTD v3.2.2 continues to be
accepted, allowing applicants to prepare for eCTD v4.0 while
maintaining continuity in current submission processes.
Continued testing and preparation for eCTDv4.0 mandatory use for new CAP MAA
A new end-to-end testing phase is currently underway to help
validate submission processes, identify technical or procedural
issues and support readiness across both industry and regulatory
authorities. Marketing Authorisation Holders are invited to participate
by providing eCTD v4.0
test submissions, particularly
if they are not yet ready to use the standard in production.
In preparation for the mandatory use of eCTD v4.0 for new CAP MAAs
from Q1 2028, the strongly recommended use will start from Q1 2027.
The timeline for eCTD v4.0 implementation for products with existing lifecycle
in eCTD v3.2.2 (forward compatibility) depends on the outcomes of testing
activities and further readiness assessments and will be updated in due course.
Ongoing and planned pilots
A pilot on eCTD v4.0 forward compatibility for CAPs has been
running since March 2026. The pilot has identified technical challenges which
are currently being addressed. A new pilot phase for forward compatibility
for CAPs is planned to commence in Q4 2026, subject to readiness of the tools and systems.
The technical pilot for new MAAs for non-CAPs is planned to start in Q3/Q4 2026.
19-03-2026
Launch of eCTD v4.0 pilot phase III on forward
compatibility for Centrally Authorised Products
The European Medicines Agency (EMA) is pleased to announce the
start of the eCTD v4.0 pilot phase III on forward compatibility for
Centrally Authorised Products (CAPs). The planned initial
duration of this phase is two to three months, with the possibility of
extension if needed.
Below you will find an overview of the pilot scope, key process steps,
responsibilities and important
Scenarios in scope of the pilot
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Scenario 1: Transform to eCTD v4.0 during an Initial Marketing
Authorisation Application (MAA)
-
Scenario 2: Transform to eCTD v4.0 at the start of a post authorisation
activity
-
Cross application scenarios: Document Reuse
How to participate in the pilot phase III
-
Pre-requisite for participation: Prospective
participants should have a Centrally Authorised Product with an existing
lifecycle for which they intend to submit eCTD v4.0 sequences.
In case some applicants do not have a Centrally Authorised
Product with an existing lifecycle but do wish to participate in the pilot,
they are invited to contact the EMA eCTD team via e-mail (eCTD4consultation@ema.europa.eu)
for specific instructions.
-
Step-by-step process for applicants:
- Contact the EMA eCTD team via e-mail (eCTD4consultation@ema.europa.eu)
by 10 April 2026 to register and request to have the test environment
added into your eSubmission Gateway account.
- Provide the routing ID of your eSubmission Gateway.
- Identify the UUID of the product for which you intend to
submit the eCTD v4.0 sequences and provide the EMA with details of the
selected product (EMEA/HC number, sequence number, submission type and
unit per sequence number).
- Create the Delivery File for the current eCTD(s) v.3.2.2 in
the production environment.
- Submit the v.3.2.2 submission package to the test
environment.
- Ensure that you have received successful acknowledgment for
the v.3.2.2 package before proceeding.
- Submit a technically valid eCTD v4.0 package to the test
environment.
EMA Responsibilities
-
Confirm applicant acceptance into the pilot.
-
Add new ‘test’ environment to the applicant eSubmission Gateway account.
-
Provide the Delivery File for the eCTD v4.0 follow-up submission unit to
the applicant.
Points for Consideration
-
It is not mandatory to include all previous eCTD sequences in the pilot.
The applicant is responsible for deciding how many sequences to include.
-
Test documents may be used in the follow-up eCTD v4 submission unit.
-
If test documents are included, the scenario(s) must be clearly
described in the cover letter.
In case of any questions regarding participation or technical requirements,
please contact the EMA eCTD team at eCTD4consultation@ema.europa.eu.
13-03-2026
EU eCTD v4.0 validation criteria v1.1 published
Following the consultation period, the final version of the
EU eCTD v4.0 Validation Criteria v1.1
is now available. The file includes the updated set of rules as well as a separate spreadsheet
that highlights all changes and the file structure and names recommendation.
eCTD v4.0 tool vendors may now begin implementing
the new rules, and the updated validation criteria will become
applicable starting 15 July 2026.
For any concerns, recommendations or questions, please send an
email to ectd4consultation@ema.europa.eu. The EMA team, together with
the EU eCTD v4.0 Subject Matter Experts, will centralise and analyse the
requests, and if considered valid, will include them in the following
version of the validation criteria.
Reminder
Applicants are invited to submit new Marketing Authorisation
Applications (MAAs) for Centrally Authorised Products (CAPs) in eCTD v4.0
format. To ensure that enhanced support is provided and that the assessment
team is aware, applicants must contact the EMA eCTD v4.0 team
(eCTD4consultation@ema.europa.eu)
prior to any eCTD v4.0 submission.
15-12-2025
Go-live announcement for EU eCTD v4.0 optional use for CAP new MAA
The European Medicines Agency (EMA) is pleased to announce that from 22 December 2025, applicants may optionally submit new Marketing Authorisation Applications (MAAs) for Centrally Authorised Products (CAPs) in eCTD v4.0.
Given the need to ensure that enhanced support is provided and that the assessment team is informed, applicants must contact the EMA eCTD v4.0 team (eCTD4consultation@ema.europa.eu) prior to any eCTD v4.0 submission.
Note that the Agency is closed from the 23rd of December 2025 until the 2nd of January 2026 included.
The eCTD v3.2.2 remains accepted during the optional-use period. Additional updates will be provided in the course of 2026.
Applicants intending to use eCTD v4.0 should ensure that their systems, processes, and tools support the EU technical requirements, including the published validation criteria and controlled vocabularies. These documents and related guidance are available on the EMA eSubmission website. An additional practical guidance for EU eCTD v4.0 (for CAPs MAA) is now published on the same page.
EMA will provide updates on further steps in the eCTD v4.0 implementation roadmap.
The introduction of eCTD v4.0 represents a significant step towards a more harmonised and efficient electronic submission environment, offering enhanced metadata structures, improved lifecycle management, and greater interoperability with global regulatory authorities.
EU eCTD v4.0 documentation:
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