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?

11-09-2024

Start of non-CAPs data load on PMS Product UI

The EMA is pleased to inform you that non-Centrally Authorised Products* (non-CAP) data are currently being loaded in read-only mode on the Product Management Service (PMS) Product User Interface (PUI), live on the live on the Product Lifecycle Management (PLM) Portal. This data load is expected to be completed by the end of September 2024, after which all non-CAP data will be available in read-only mode on the PUI.

IMPORTANT: To avoid platform overload and preserve the performance of the PLM platform while the data load is ongoing, the EMA requests that National Competent Authorities (NCAs) refrain from requesting PMS roles at this time. Current PLM PUI and eAF users are also strongly encouraged to minimise activity on the PLM Portal.

Please note, this data load will not yet trigger the availability of non-CAPs in the web-based electronic Application Form (eAF). Following the deployment of further performance improvements, non-CAPs will become available also in the eAF. During the non-CAP data load, users of the PLM Portal and IRIS Industry & Network Portal may experience minor performance issues, such as slower system responses. In such circumstances, users do not need to raise this via EMA Service Desk.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

06-09-2024

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 1.0.1.18 released to production on 06 September 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

28-08-2024

Updated PLM Portal eAF guide to navigation now available

An updated version of the draft PLM Portal eAF guide to navigation is now available. The change is in chapter 2.2.4 (Add product), page 40, and it is related to the introduction of a temporary popup message, while the adding of the products and all the afferent processes are finalised.

And

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 1.0.1.17 released to production on 27 August 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

27-08-2024

Planned maintenance of the eSubmission Gateway XML delivery file on 2 September 2024

Due to planned maintenance, the eSubmission Gateway XML delivery file will not be available on Monday 2 September 2024, between 18:00 and 19:00. For any further information, please contact EMA Service Desk.

08-08-2024

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 1.0.1.16 released to production on 08 August 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

23-07-2024

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 1.0.1.15 released to production on 22 July 2024 are now available on PLM Portal Forum and on the PLM Portal eAF web page.

22-07-2024

Updated PLM Portal eAF guide to navigation now available

An updated version of the draft PLM Portal eAF guide to navigation is now available.

17-07-2024

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 1.0.1.14 released to production on 15 July 2024 are now available on PLM Portal Forum and on the PLM Portal eAF web page.

11-07-2024

Invitation to register for the Info Session on PLM Portal eAF - Add package

EMA will host an Information session on 18 July 2024, 11:00 - 12:00 (CEST) to explain and showcase the latest developments and bug fixes deployed in the PLM Portal web-based electronic Application Form (eAF), namely the add package feature. Participants will have the opportunity to ask questions in the last part of the session.
The eAF add package functionality allows the applicants to use the web based eAF for variations adding a new pack size.
The participation is recommended to Industry stakeholders who are filling in application forms for their respective organisations.

Register here, and check the event web page for agenda, presentation and recording.

01-07-2024

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 2.0.1 in the PLM Portal eAF (released to production on 28 June 2024) are now available on the PLM Portal and in the section of the PLM Portal eAF, Documentation section, together with several updated documents to provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.0.1 or to start the implementation now with the latest version.

18-06-2024

eCTD 3.2.2 new package available

A new version of the EU eCTD M1 Specification, version 3.1, is now published on the eSubmission website

The version 3.1 sees the introduction of a number of changes across the specification, however, more specifically, the introduction of a new annex detailing the list of accepted file formats
(Reminder: the generally accepted file format is the PDF, however, in specific cases, other formats will be exceptionally accepted in the eCTD modules). The changes are reflected in the Release Notes.
The same changes are reflected in the additional files of the EU M1 Implementation Guide package (i.e. eu-envelope.mod, eu-regional.dtd, eu-regional.xsl)

A new version of the validation criteria 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.

During the initial period of 6 months from 18 June 2024 to 30 November 2024, applicants can only submit eCTD format submissions compliant with EU M1 v3.0.4 and validation criteria version 7.1.

From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1 or v8.0 are accepted.

From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.0 are accepted.

13-06-2024

ICH Call for Vendor participation now open

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:

• First Name;
• Last Name;
• Email;
• Company Name;

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.

AND

ICH eCTD v4.0 package updated

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.

11-06-2024

Planned maintenance of the PSUR Repository (NCAs only) on 18 June 2024, 18:00 CET

Due to planned maintenance, the PSUR Repository NCA UI and PSUR Repository NCA API will not be available for approximately 1 hour on Tuesday, 18 June 2024, after 18:00 CET. The maintenance is related to a technical upgrade and will not result in any changes of the features and functionalities of the system.

AND

Planned maintenance of the eSubmission systems on 19 June 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Wednesday, 19 June 2024, between 18:00 and 21:00: Common Repository Web-UI (relevant for NCAs only) and Common Repository API (relevant for NCAs only). During the same interval, the Gateway Filehandler will experience short delays in sending the acknowledgements of the processed submissions.

03-06-2024

PMS Product UI Now Live on the PLM Portal

The PMS Product User Interface (PUI) was launched on 31 May 2024, in read-only mode on Product Lifecycle Management (PLM) Portal. Registered users are now able to view Centrally Authorised Product - (CAP) data in the PUI (Nationally Authorised Product (NAP) data will be available in early Q3 2024).

Please note that the eAF users have now automatically access to the PUI. Consult these guidance documents and join the 3 June 2024 training session to prepare for registration & navigation of PUI.

17-05-2024

Updated PLM Portal Guide to Navigation is now available

Please find an updated version of the draft PLM Portal eAF Guide to Navigation here.

AND

New Paediatric submissions are mandatory via IRIS platform from 4 June 2024

Please note that from 4 June 2024, the following types of new paediatric submissions must be carried out via IRIS:

• Initial paediatric investigation plan (PIP)
• Modification of an agreed PIP
• Product-specific waiver
• Compliance check
• Annual report on paediatric deferred measures
• Confirmation of applicability of a class waiver, or inclusion of an indication within a condition
• Discontinuation of paediatric development.

To ensure a smooth transition to using the IRIS platform, it is essential that applicants prepare well in advance, including registering for IRIS, as described in the following document:

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration-and-rpis_en.pdf

The gateway is open for ongoing paediatric procedures only.

15-05-2024

A new PLM Portal Home page

New, product specific tiles for electronic Product Information (ePI) and the Product Management Service (PMS) Product User Interface have been included in addition to the web-based electronic Application Forms on the PLM Portal's landing page. To ensure users can find and easily access these tools, EMA has updated the landing page of the Portal, which now presents a new look & feel.

The new interface aims to provide more intuitive access to eAF, PMS and ePI release notes, news, knowledge articles.

We would like to invite you to share your feedback on the new landing page in the PLM Portal Forum.

AND

Recommended use of web-based human variations eAF for all CAPs

As anticipated in April 2024 communication and announced in May 2024 at the webinar “Information and Q&A session on updated CAPs in web-based eAF” (recording & presentation available), we have completed the load of updated* Centrally Authorised Products (CAPs) data to PLM Portal web-based eAF on 19 April 2024. Users can now access this new CAP product data directly within the web-based forms.

We are pleased to announce that we recommend the use of the PLM Portal web-based eAF for all CAPs variations starting from 14 May 2024. However, please be aware that there are still some known issues and limitations that we are actively addressing however, these issues do not prevent the use of the web-based eAF. We invite you to consult the 7 May webinar presentation for the complete list of known issues.

If you encounter any issues, please report them via EMA Service Desk, ensuring that you select the correct category.

*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.

26-04-2024

Paediatric submissions to launch on IRIS platform from 4 June 2024

24-04-2024

Register for the Information and Q&A session on updated CAPs in PLM Portal eAF, 7 May 2024

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