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?

13-01-2025

Planned maintenance of eSubmission systems on 14 January 2025, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 14 January 2025, between 18:00 and 19:30: Gateway XML delivery file user interface, Gateway Filehandler, PSUR Repository Web-UI. For any further information, please contact EMA service desk.

09-01-2025

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 1.1.1.1 released to production on 7 January 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

Important note to PLM Portal users:

Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product data will be removed from the Product Lifecycle Management Portal from 13 to 17 January 2025:

• All ingredients and their strengths
• Pharmaceutical products and routes of administration
• Package Items, Package Item Materials, Package Manufactured Items
• ATC codes

This means the above data will be unavailable in Product Management Service Product User Interface and Human Variations electronic Application Form.

In practice, for PLM Portal web-based eAF users this means that fields containing this information will be empty in the eAFs generated from the PLM Portal during this period. The missing data is not expected to impact the users of the eAF for variations for Centrally Authorised Products; and eAFs submitted with empty fields where the data is ‘missing’ due to the data cleansing exercise will not be rejected. We kindly request you not to report missing data/data issues in the eAF via the EMA Service desk during this period.

This means that PLM Portal eAF users should be able to continue to use the web-based form during this period unless unexpected issues, that were not found during testing, are found once the data cleansing process starts. However, users should note that the interactive pdf eAF is available for use for all variation procedures and applicants may feel more comfortable using the pdf eAF .

From 20 January 2025, the removed data will be re-uploaded in phases:

• All Centrally Authorised Products' (CAPs) data will be available from 20 January 2025;
• Non-CAPs data will gradually reappear over the following two weeks.

08-01-2025

ESMP pre-launch for MAHs and available training materials

As of 28 November 2024, the European Shortages Monitoring Platform (ESMP) is officially live for routine shortage reporting by marketing authorisation holders (MAHs).

Marketing authorisation holders (MAHs) can now submit data to routinely report shortages of centrally authorised medicines (CAPs) to EMA. This marks the start of a transition period that will end on 2 February 2025, when the use of the platform becomes mandatory for CAP shortage reporting to EMA. National reporting requirements remain applicable. The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA.

The full first version of the ESMP will be released by 2 February 2025 and will expand the platform's functionalities to include supply, demand, and availability reporting during crises and MSSG-led preparedness exercises by MAHs and NCAs.

Further information, including training materials, user guidance, and ESMP webinar and ESMP training event recordings, are available on EMA's website to support stakeholders. For more details, visit the ESMP webpage and the press release on EMA's website.

13-12-2024

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 1.1.1.0 released to production on 9 December 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

And

Update on the start of strongly recommended use of web-based eAF for NCA submissions

The expected start date of the strongly recommended use of the PLM Portal web-based eAF submissions to the National Competent Authorities for non-CAPs variations is now planned for February 2025. This updated timeframe is based on the latest projections by EMA’s development teams.

Please note that the web-based eAF is fully functional for the submission of variations for CAPs, including EMA-led worksharing variations containing non-CAPs.

Should you have any questions or require further information, please do not hesitate to contact us at plm.valuestream@ema.europa.eu.

12-12-2024

EU eCTD v4.0 Controlled Vocabularies in .xml format now available

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.

12-12-2024

Updated PLM Portal eAF FHIR XML Release notes now available

An updated version of the PLM Portal eAF FHIR XML Release notes reflecting the implementation of FHIR XML 2.1.1 in the PLM Portal eAF (released to production on 9 December 2024) are now available on the PLM Portal and in the documentation section of the PLM Portal eAF, together with several updated documents to provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.1.1 or to start the implementation now with the latest version.

10-12-2024

eSubmissions Gateway – naming of the working documents folder

When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.

Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence "0007", which contains working documents, the separate folder should be named "0007-workingdocuments".

More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0.

05-12-2024

EU Harmonised technical eCTD guidance version 6.0 now available

A new updated version of the eCTD EU Harmonised technical guidance is now available here, together with the Release notes.

The EU Harmonised technical guidance is aligned with the EU M1 eCTD Specification v3.1 and the Validation Criteria v8.1.

The timeline for implementation is as follows:

• (optional use): From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1 or v8.1 are accepted.
• (mandatory use): From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.1 are accepted.

And

Updated version of the VNeeS specification v3.2 now available

The guideline on eSubmissions for Veterinary products version 3.2 has now been published. It will enter into force on 1 January 2025 (see links under section "Current Guidance" below).

The update is related to text changes only (detailed in the release notes for version 3.2) and it does not affect the validation criteria.

And

Updated VNeeS Q&A relating to eSubmission for Veterinary Applications now available

The VNeeS Q&A relating to eSubmission for Veterinary Applications was updated and it can be found in the Current Guidance section.

04-12-2024

Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5 December 2024, between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common Repository Web-UI and API, PSUR Repository Web-UI (both NCA and industry access) and API.

The maintenance includes various improvements and implementations:

• Common Repository Web-UI - technology modernisation
• Gateway XML delivery file user interface - various improvements and integrations for retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
• Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g. renaming of the submission mode from "IG" to "super-grouping")

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

03-12-2024

Call for Interest eCTD v4.0 Technical Pilot

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

• Participants: Tool vendors, EMA
• Timeline: Q4 2024 - Q1 2025
• Focus Area: Technical Interoperability

• Participants: Tool vendors (potential collaboration with MAHs), EMA
• Timeline: Q1 2025 (Subject to finalisation of step 1) - TBD
• Focus Areas:
• Simple scenarios (mock submissions, single package/sequence)
• Document lifecycle management (e.g. replacements, updates)
• Handling of multiple file formats, pack sizes, manufacturers
• Review of controlled vocabularies (CV)
• Updating keywords, priority numbers, and document titles
• Document reuse

• Participants: Tool vendors, MAHs, EMA
• Timeline: Subject to finalisation of step 2, TBD
• Focus Areas:
• Expansion of Step 2 scenarios with non-mock data
• Grouped submissions functionality, forward compatibility
• Parallel regulatory activities

PFor a high-level view, please refer to the attached pilot plan.

02-12-2024

Updated eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025

An updated/corrected version of the eAF 1.27.0.0 (Human variation) is now available on the eSubmission website. The difference compared to the version published on the 27^th of November is in the exported XML, which now correctly contains the super-grouping checkbox.

It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start date after 1^st of January 2025.

The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for procedures starting until 31 December 2024. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Please note that in case you need to provide an update to a form that has been submitted prior to 1^st of January 2025, you should use the previous version (1.26.0.0).

27-11-2024

EMA encourages companies to submit type I variations for 2024 by end November 2024

EMA is advising marketing authorisation holders to submit type IA and type IA_IN variations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 20 December 2024 and 5 January 2025, within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2024 for a start of procedure in 2024. For submissions received on or after 1 December 2024, the procedure may not start until January 2025.

and

eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025

In line with the amended Variation Regulation entering into force on the 1^st of January 2025 ( Guidance on the application of the amended Variations Regulation from 1 January 2025 | European Medicines Agency (EMA) ), a new version of the Human Variation eAF v1.27.0.0 is now available on the eAF website.

It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start date after 1^st of January 2025.

The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for procedures starting until 31 December 2024. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Please note that in case you need to provide an update to a form that has been submitted prior to 1^st of January 2025, you should use the previous version (1.26.0.0).

The form, the release notes and the associated files (i.e. schema and dictionary) are published in the relevant sections of the eAF webpage.

26-11-2024

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 1.1.0.3 released to production on 25 November 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

18-11-2024

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 1.1.0.2 released to production on 11 November 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

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

An upcoming updated package (containing the genericode files for the controlled vocabularies and the validation criteria) will be made available in the coming period.

The package is meant for eCTD tool vendors to access the new format of the Controlled Vocabularies and the new OIDs, as well as to be notified by the changes in the EU eCTD v4.0 Implementation Guide (version 1.2).

According to the EU eCTD v4.0 implementation timeline, a technical pilot for eCTD v4.0 in EU (focused on CAPs) is planned to start by the end of 2024, and more details will be published on the eSubmission website. If you are an eCTD tool vendor, have already developed eCTD v4.0 capabilities in the tool and are interested in participating in the EU eCTD v4.0 pilot, follow the eSubmission website for the upcoming announcement, or send your intention to join the pilot at ectd4consultation@ema.europa.eu.