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?

24-02-2026

Planned maintenance of eSubmission systems on 27 February 2026, 17:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Friday 27 February 2026, between 17:00 and 21:00 CET: Gateway XML FileHandler and PSUR Repository. For any further information, please contact EMA service desk.

18-02-2026

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 1.2.1.6 released to production on 16 February 2026 is now available on the eSubmission PLM Portal eAF web page.

03-02-2026

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 1.2.1.5 released to production on 02 February 2026 is now available on the eSubmission PLM Portal eAF web page.

20-01-2026

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 1.2.1.4 released to production on 19 January 2026 is now available on the eSubmission PLM Portal eAF web page.

13-01-2026

ESMP update: Expansion in progress | ESMP webpage reorganisation | New ESMP factsheets and updated FAQs

As part of EMA’s ongoing commitment to enhance the European Shortages Monitoring Platform (ESMP) and support its users, the ESMP is expanding with new functionalities, and the development work is progressing. In addition, new and revised support materials are now available on the ESMP webpage, which has been reorganised with some content moved to two dedicated subpages.

ESMP expansion
The ESMP is expanding to include new tools and features that will better support stakeholders in preventing, managing, and mitigating medicine shortages:

• Voluntary solidarity mechanism workflow (for Member States): Implementation of a data submission and management workflow in the ESMP that allows Member States to flag critical national shortages of specific medicines, enabling other Member States to indicate available stock that could potentially be redistributed.
• Critical shortage reporting workflow (for Member States): This feature builds on the current reporting of critical shortages by NCAs to EMA and streamlines the submission and management of critical shortage notifications.
• Vulnerability assessment methodology testing (for the MSSG): In line with the upcoming pharmaceutical legislation reform, this functionality will support the MSSG in testing and automating a new methodology to identify vulnerabilities in the supply chains of medicines. It will allow step-by-step testing and provide initial large-scale analysis using defined indicators.

New ESMP webpage subpages
The ESMP webpage content has been revised and some content reorganised into two dedicated subpages:

• ESMP guidance, training materials and events page - hosting all user and implementation guidance, training materials and information on ESMP events.
• ESMP interoperability page - focused on information on the platform’s interoperability with national and pharmaceutical industry systems.

New and updated resources
To further support stakeholders in fulfilling their reporting obligations new concise factsheets and updated FAQs are available:

• ESMP Factsheets: four one-page summaries of MAHs and NCAs reporting obligations and processes in times of routine shortages, crises, or MSSG-led preparedness actions.
• ESMP FAQs: revised and expanded, with update details available in the revision history table.

07-01-2026

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 1.2.1.3 released to production on 06 January 2026 is now available on the eSubmission PLM Portal eAF web page.

AND

Planned maintenance of eSubmission systems on 10 January 2026

Due to the essential maintenance, AXWAY Gateway will be unavailable between 09:00 and 18:00 on Saturday, 10 January 2026. During this period submissions will not be processed.

For any further information, please contact EMA Service Desk

05-01-2026

Planned maintenance of eSubmission systems on 07 January 2026, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Wednesday 7 January 2026, between 18:00 and 24:00 CET: Gateway XML FileHandler and PSUR Repository. For any further information, please contact EMA Service Desk.

16-12-2025

New variation classification in eAF - reminder for cut-off date 15 January 2026

The updated Variation Regulation Classification Guideline has been made available in the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.

Applicants are reminded that applications using the v1.28.0.0 or the January 2026 version of the form must not be submitted to the EMA prior to 15^th January 2025 CET 00:00. Applications received before the 15^th January 2025 will be rejected, and the application must be resubmitted on or after the 15^th January 2026.

For any exceptions to these rules and applicability for different scope types must be reviewed on the following EMA dedicated page: Guidance on the application of the revised variations framework | European Medicines Agency (EMA)

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New variation classification in eAF - Q&A session - 8 January 2026 10:00 - 11:00 CET

The updated Variation Regulation Classification Guideline has been made available in the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.

To support this change, the EMA eAF team will host a Q&A Clinic on 8 January 2026 10:00 - 11:00 CET dedicated to addressing your questions about the eAF form functionalities related to the new variation classification. To register, please use the following link: Q&A eAF registration - 8 January 2026.

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PLM Portal eAF - reminder for FHIR XML attachment

Applicants are reminded that eAFs generated in the PLM Portal need to have the FHIR XML attached when submitted to health authorities. The applicants need to check that all PLM Portal eAFs contain the FHIR XML before adding them to the eCTD package. For more information, please consult the eAF - Guidance Documents

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.

12-12-2025

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 1.2.1.2 released to production on 11 December 2025 is now available on the eSubmission PLM Portal eAF page.

10-12-2025

PLM Portal eAF - updated Q&A document

The PLM Portal eAF Q&A has been revised to incorporate questions gathered during the 2025 webinars and Q&A sessions.
The newly added questions are clearly marked with the label "Nov '25" for ease of identification.

It is highly recommended to review this document before initiating the creation of a PLM Portal eAF for a human variation, as well as during or after completion, should you have any inquiries or encounter difficulties. Doing so ensures compliance with the latest guidance and supports the efficient resolution of potential issues.

10-12-2025

EU eCTD v4.0 - Forward compatibility pilot for CAPs to be announced in 2026

EMA is pleased to announce that we are planning to start the Pilot Phase 3 on Forward Compatibility for the Centrally Authorised Products in 2026.

We strongly encourage all eCTD v4.0 tool vendors to ensure that their tools are ready to support Forward Compatibility in early 2026.

Further information and details how to participate will be published on the eSubmission website in Q1 2026.

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EU eCTD v4.0 - Validation criteria v1.1 - open for comments

The eCTD v4.0 EU Validation Criteria is under review. The draft updated validation criteria v1.1 is now available for your comments. Please send us your feedback via email to eCTD4consultation@ema.europa.eu by 31^st December 2025.

02-12-2025

PLM Portal eAF - January 2026 final version now available

The final "January 2026" version containing the new human variation classification, entering into force on 15 January 2026, is now available on the PLM Portal eAF.

A single cut-off date for the entry into application (i.e., 15 January 2026) is set out in the final version of the Variations Guidelines. Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and on the specific procedural guidance. Please review this page for further details: Guidance on the application of the revised variations framework

Findings related to the functionality of the form must be consolidated and submitted via an EMA eAF ticket.
Findings related to the classification scopes (Section 3 of the eAF) must be raised through an RMS change request.

Note: The z-scopes are not visible yet in the new variation classification, they will be added soon.