eSubmission: Projects

EMA is pleased to announce that the phase 2 of the eCTD v4.0 EU Technical pilot (CAPs) continues and is progressing well. We are receiving submissions and useful findings have been made. The participants should note that we are extending the phase 2 until the end of September 2025 to ensure that there is time to receive and analyse further packages following important fixes into the review tool.

We would also like to highlight to the users the importance of using priority numbers and careful use of keywords to ensure that sections, such as 1.3 are not displayed multiple times.

The genericode format of the EU eCTD v4.0 controlled vocabularies (v2) (published on the 8th of August in excel format only) is now available. A new version (v3) will be published in the upcoming weeks, containing new terms and corrections of existing terms.

EMA is pleased to announce that the phase 2 of the eCTD v4.0 EU Technical pilot (CAPs) is ongoing, and progressing as planned. The participants should take note that "multiple pack sizes" (Scenario 1) is not meant to be reflected in the structure of the submissionUnit.xml, but it is simply related to the content (the documents) of the test applications.

The few changes compared to the previous version are highlighted in the document, and marked with new/updated, accordingly.

This version of the controlled vocabularies contains the new OID of the Implementation guide (1.3), which will also be published in the upcoming weeks.

The EMA eCTD team and the EU eCTD v4.0 Subject Matter Experts are pleased to announce that a draft EU eCTD v4.0 validation criteria is now available here. The list is a combination of rules existing in eCTD 3.2.2 (adapted to the new standard, where necessary), and new rules, extracted from the eCTD v4.0 specification, mainly related to the schema (for example mandatory elements and attributes). The EU eCTD v4.0 validation criteria complements the latest eCTD v4.0 ICH validation criteria.

The list is focused on the centrally authorised products (CAPs) and will be further edited to contain rules for MRPs, DCPs and NAPs

The eCTD tool vendors are encouraged to start implementing the rules, in preparation for the optional use of eCTD v4.0 for CAPs, planned for late Q4 2025. The scope of the optional use and the actual start date depend on the results of the ongoing eCTD v4.0 technical pilot, and will be communicated in Q4.

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.

The electronic Common Technical Document (eCTD) v4.0 team is pleased to launch Step 2 of the eCTD v4.0 Technical Pilot, for Centrally Authorised Products (CAP). Please note that the participation is very limited and the participants will be selected based on the readiness and compliance with the scenarios and focus described below.
We would like to invite interested MAHs to provide details of their proposed products, scenarios and very importantly the name of the eCTD v4.0 tool, by 15 July by email to eCTD4consultation@ema.europa.eu. Upon confirmation from EMA will send details on how the test packages can be submitted

Important notes

all the test submissions from Step 2 will be processed in an EMA Test environment and the submission channel will not be EMA Gateway
a first draft of the validation criteria will be published in the upcoming weeks, and the initial test submissions of Step 2 will not go through a “standard” validation

The main scenarios below will be followed, but please send your proposals for different/new scenarios when expressing your interest to participate:

Scenario 1. Initial MAA (sequence 1); EMA will prioritise for processing those MAHs who can resubmit sequence 1 for an existing/already authorised CAP (previously created in eCTD 3.2.2, sequence 0000, even if currently is not a valid product anymore), and now re-created/converted (fully or partially) in eCTD v4.0.

controlled vocabularies
different file formats
multiple pack sizes, manufacturers

Scenario 2. Initial MAA (sequence 1) for a Duplicate product sent in scenario 1 (the Duplicate product can be a mock product; this will facilitate early testing of Grouped submissions functionality, which is planned for Step 3)

Document reuse
different file formats

Scenario 3. Validation responses (starting with sequence 2), responses

Document lifecycle management (replace context of use (one to one, one to many and many to one), delete)
Updating keywords, priority numbers, and document titles
Regulatory activity (Submission and related sequences for 1 regulatory activity)

Scenario 4. Post authorisation activities (different procedure types and multiple sequences related to the products sent in sequence 1)

Document lifecycle management (replace context of use (one to one, one to many and many to one), delete)
Updating keywords, priority numbers, and document titles
Parallel regulatory activities

In Step 2 (the planned initial duration of this step is 2 months: 15 July – 15 September, subject to extension if necessary) of the eCTD v4.0 of the technical pilot there will be no focus on Grouped submissions functionality, forward compatibility. These will be tested in Step 3, planned for late Q3 2025.

Please note: all the communication will take place over email and depending on the number of test packages received and EMA eCTD v4.0 team availability, there might be a delay in the response time.

An updated version of the EU eCTD v4.0 Controlled Vocabularies is now available here. The updated package contains the missing list (territorial authority) and the unused list was removed (dosage form category).

The package containing genericode (.xml) format for the first version of the EU eCTD v4.0 Controlled Vocabularies is now available here. They are complementing the .xlsx version which was published in October.

The electronic Common Technical Document (eCTD) v4.0 is pleased to announce the launch of the eCTD v4.0 Technical Pilot and invite interested eCTD tool vendors to participate in Step 1. A call for participation in the following steps will be launched at a later stage.

If you have not yet expressed your interest, please send an email to eCTD4consultation@ema.europa.eu by 20 December 2024 to express your intention to participate. If approved, you will receive a confirmation e-mail with further instructions.

Step 1

An updated draft version of the EU eCTD v4.0 implementation package is now available here.

The package contains the following:

The ICH eCTD v4.0 package has been updated in response to the change requests and/or discussion within the EWG after its initial release. There has been number of updates to the ICH IG and both the Support Documentation and the Orientation Material presentations have been updated. Additionally, as of May 2024, the Implementation Guide and Controlled Vocabulary documents were split into two different packages to enable Controlled Vocabulary Versioning.

More information can be found on the ICH Official web site: ICH.

A call for vendor participation is now published on the ICH Official website. If you are an eCTD v4.0 Tool Vendor and would like to join the eCTD Tool Vendor Group to discuss eCTD v4.0 implementation, please send the following information listed below to ICHM8Vendors@ich.org:

Please note that your information will be shared as needed with Representatives of ICH Members and Observers involved with ICH eCTD activities.

The Vendor Group kick-off meeting will be held on 17 July 2024, at 7.00 A.M. ET.

The vendor group is solely intended to facilitate collaborative discussion on the eCTD v4.0 Implementation Specification and timelines.

More information can be found on the ICH Official web site: ICH.

The electronic Common Technical Document (eCTD) is the standard norm for industry submissions for over 20 years and currently implemented by regulators and industry in version 3.2.2. Version 4.0 of eCTD was published in December 2015 with its most recent Implementation Package v1.5 endorsed at the May 2022 ICH meeting.

This workshop, organised and facilitated by the eCTD v4.0 SME Group (EMA, NCAs and Industry), is intended for all eCTD Vendors that are interested in better understanding changes to the EU regional eCTD Specification. The event aims at fostering a discussion around the key sections of the new version of the Implementation Guide, the technical understanding of the implementation of the new standard, including the grouped submissions, document re-use and controlled vocabularies. At the moment, the focus will be on the Centralised Procedures only.

Moreover, during the workshop, the scope and timeline of the pilot, as well as the timeline for the updates of the Implementation Guide, will be discussed.

This session also offers an invaluable opportunity for participants to ask questions and provide feedback on pertinent matters.

After registration you will receive a confirmation e-mail with the link and password to access the workshop. Please make sure to save those to be able to participate to the workshop.

A new draft version of the eCTD v4.0 EU M1 Implementation Guide is now available here for consultation. Future versions (together with EU Controlled Vocabularies and other annexes) will be published and announced on the eSubmission website.

EMA, together with the eCTD v4.0 EU Subject Matter Experts group, is planning a Vendor Workshop in Q1 2024. To assess the availability, interest and further topics for discussion, the Vendors are invited to complete the eCTD v4.0 Vendor Workshop survey by end of day 15 February 2024.

Please see below an updated draft timeline for the implementation of eCTD v4.0 in the EU.