To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.

For details on how to find us please click here.

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What's New in eSubmission Today?

30-10-2024

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.0.1 released to production on 28 October 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

29-10-2024

Interactive PDF eAF technical documentation updated

An updated set of schemas were published under the "Technical Documents" section of eAF (interactive PDF), relevant for small changes in the XML schema definition for versions 1.26.0.0 and 1.26.0.1. The changes are reflected in the "eAF DES change summary" document.

28-10-2024

Minor update to the published EU Validation criteria

An updated version of the validation criteria to add further clarification the has been published on the eSubmission website. The version is related to the EU Module 1 Specification version 3.1 and should be used in case of submitting a new sequence according to EU M1 specification v3.1. The new validation criteria will be used for the technical validation for all v3.1 electronic submissions received as of 1 March 2025 to the NCAs and EMA. The changes are reflected in the Release Notes.

From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1, 8.0 or v8.1 are accepted.

From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.1 are accepted.

24-10-2024

Planned maintenance of eSubmission systems on 24 October 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Thursday 23 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository XML delivery file UI (relevant for industry only).

Previously created delivery files will continue to work. For any further information, please contact EMA Service Desk.

14-10-2024

Non-Centrally Authorised Products now available in the PLM Portal eAF

The EMA is pleased to announce that the non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.

Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations containing CAPs and non-CAPs.

Please join the training session on 17 October 2024 10:00 - 11:30 (CEST).

Please see an updated version of the draft PLM Portal eAF guide to navigation is now available.

04-10-2024

EU eCTD v4.0 draft Implementation package now available

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

The package contains the following:

• EU eCTD v4.0 Implementation Guide draft version 1.2 ; this version is focused on CAPs and the main changes since version 1.1 are reflected in the "Document change history" of the file
• EU eCTD v4.0 Controlled Vocabularies, in .xlsx format (version 1); the genericode files (.xml format) will be published in the following weeks
• EU eCTD v4.0 Accepted file formats

03-10-2024

Non-CAPs data available in the PLM Portal web based eAF from 14th October 2024

The EMA is pleased to announce that, as of the 14 October 2024, non-Centrally Authorised Products* (non-CAPs) data will be available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.

Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations of non-CAPs.

In order to familiarise with the new functionality of web-based eAFs for Human non-CAP variation procedures, the eAF team is providing a dedicated training session on 17 October 2024 10:00 - 11:30 (CEST). During this event, access and navigation of web-based eAF for non-CAPs will be showcased. We would highly recommend all relevant Industry stakeholders to participate to this training: Register here

Key actions for Marketing Authorisation Holders:

• Register as an eAF user in the PLM Portal following the registration process and log into the eAF for familiarisation and testing purposes;
• Join upcoming training session;
• Follow EMA announcements to be informed of the date when web-based eAF can be submitted to the NCAs. This is currently expected to start in January 2025;
• Continue to submit the interactive PDF eAFs to the NCAs for non-EMA led procedures;
• Gather user feedback related to non-CAP variations within your organisations (MAHs and industry organisations) and to provide this consolidated feedback to EMA via plm.valuestream@ema.europa.eu.

Key actions for NCAs to:

• Follow EMA announcements to be informed of the date when they will start receiving web-based eAF submissions.
• Forward any non-CAP variations related user feedback from MAHs to EMA via plm.valuestream@ema.europa.eu
• Join upcoming information session on the go-live of the web-based eAF for non-CAPs - to take place in November 2024.

eAF guidance documents available to support your work on the PLM:

• Guide for PLM Portal Registration - Document
• Guide for PLM Portal eAF Navigation - Document

Please be reminded that:

• External testing of the eAF User Acceptance Testing (UAT) is not foreseen for 2024
• No transition towards mandatory use of the Human variations web-based eAF will start before a UAT takes place

23-04-2024

Successful CAPs data load under review, recommended use of interactive PDF extended

19-04-2024

Updated VNeeS checker for v3.1.1 now available

11-04-2024

Updated eAF v1.26.0.1 (Vet MAA) now available

An updated v1.26.0.1 Vet MAA eAF is now available on the eSubmission website.
A change has been implemented to fix a bug related to the navigation in the form after its finalisation.

It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes will be updated and published in the relevant section of the eAF page.

AND

electronic Application Forms (eAFs) not available for use between 11th and 16th April 2024 due to planned maintenance

Due to planned maintenance activities, the interactive PDF eAFs (human and veterinary variation and MAA forms and the renewal form) and the PLM Portal web-based eAF will be unavailable for use between 11th and 16th April 2024.

Please refer to the news published on 15 March 2024 for the complete details of the planned maintenance and we remind you that we strongly recommend to use the interactive pdf eAF instead of the web-based eAF for submissions at least until 26 April 2024 to prevent validation issues and potential delays.

20-03-2024

Planned maintenance of the eSubmission systems on 25 March 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Monday 25 March 2024, between 18:00 and 21:00: Gateway XML delivery file user interface and Common Repository Web-UI (relevant for NCAs only).

The maintenance includes the introduction of a new field in the eSubmission Gateway XML delivery file user interface (EPITT number for pam-sda submissions), and other small bug fixes and improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.

Updated documentation will be published on the relevant pages of the eSubmission website. For any further information, please contact EMA Service Desk.

15-03-2024

electronic Application Forms (eAFs) not available for use between 11th and 16th April 2024 due to planned maintenance

Due to planned maintenance activities, the interactive PDF eAFs (human and veterinary variation and MAA forms and the renewal form) and the PLM Portal web-based eAF will be unavailable for use between 11th and 16th April 2024.

Additionally, as announced in December 2023, the PLM Portal web-based eAF will be affected by the data load of Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) into Product Management Service (PMS) as well as the simultaneous load of updated* CAPs to web-based eAF.
This load of data into PMS is a necessary step in preparation to the forthcoming launch of the Product User Interface view and later edit functions as well as making NAPs data available for the PLM Portal web-based eAF.

The data load will take place from 11 to 16 April 2024. During this timeframe, the interactive PDF eAF and the PLM Portal web-based eAF will experience a downtime.
Please note that, during the preparation for the updated* CAPs load in the PLM Portal web-based eAF, the match-merge** operation will result in:

• changes to product names;
• introduction of new medicinal products through splitting**;
• potential alterations to packages.

These changes will impact how products appear in application forms. Therefore, we strongly recommend, with immediate effect, that no applications that might require any update of the eAF, during or after the product upload, are submitted to EMA using the PLM Portal web-based eAF. We strongly recommend to use the interactive pdf eAF instead of the web-based eAF for submissions at least until 26 April 2024 to prevent validation issues and potential delays.
Please note that if you have already submitted a web-based eAF, or it is expected that there will be no need to update the form and/or the procedure will conclude prior to the downtime, you can continue using the web-based eAF.

Please note that, except for the downtime period, the web-based eAF is expected to remain accessible to applicants to familiarise themselves with changes to the products, and for training purposes.

*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
**The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in EU IG Chapter 7

15-03-2024

Register for the eCTD v4.0 Vendor Workshop on 27 March 2024

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.

Register for this workshop.

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.

15-03-2024

Planned maintenance of the Common Repository Torrent in the evening of 21 March 2024

Due to planned maintenance, the use of the Torrent files via client to download the content will not be possible on Thursday 21 March 2024, between 18:00 and 21:00. For any further information, please contact EMA Service Desk.

14-03-2024

eCTD v4.0 EU M1 Implementation Guide - draft Version 1.1 now available

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.

29-02-2024

Updated eAF v1.26.0.1 (Vet MAA) now available