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Human eSubmission
eCTD v3.2
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eSubmission expert group
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eSubmission expert group documents
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External Links
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Systems:

Common Repository

eAF
eASMF
ePMF
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PLM Portal eAF (DADI)

PLM Portal
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PSUR Repository

Industry access
NCA access
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Projects:

eCTD v4.0

Paediatric submissions

SPOR

eSignatures
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Introduction

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.

eSubmission eAFRSS news feed

Previous news is available here
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What's New in eSubmission Today?
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21-03-2023

Feedback Survey for PLM Portal Users (Deadline: 31 March 2023)

Following the launch of the Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) Portal, we appreciated many users have accessed the PLM Portal to work on variation applications using the new web-form.

We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations

This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.

Please note that the survey will be anonymous and the results will not be publicly disclosed. The survey will stay open until 31 March 2023.

This should not take more than 5 minutes.

17-03-2023

Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only)

We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic Authentication’ is going live on the 20th of March 2023 (originally planned for the 14th of March). This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products.

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Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening

Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening Due to planned maintenance, Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening, 20th of March 2023 between 17:30 and 20:30 (CET). For any further information, please contact Service Desk

And

Planned maintenance of the eSubmission systems on Saturday 25 March 2023

Planned maintenance of the eSubmission systems on Saturday 25 March 2023 The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk

14-03-2023

Common Repository Go-Live (relevant for NCAs only)

We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic Authentication’ is going live on the 14th of March 2023. This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products. For the completion of the deployment, Common Repository UI and API and eSubmission Delivery File UI will be unavailable this Tuesday evening, 14th of March 2023 between 18:30 and 19:30 (CET).

09-03-2023

Updated variation FHIR mapping and conceptual data models

The Variation FHIR mapping and the conceptual data models have been updated and are now available here.

08-03-2023

eAF-PMS FAQs Document Publication

The eAF and PMS teams are pleased to announce that an eAF-PMS FAQs Document is now available here. This document contains Frequently Asked Questions on eAF and PMS and will be updated regularly.

28-02-2023

Common Repository and eSubmission Logs unavailable this Tuesday evening

Due to essential maintenance, Common Repository and eSubmission Logs, will be unavailable on Tuesday 28 February 2023 between 18:00 and 20:00 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk

And

PSUR unavailable this Wednesday evening

Due to essential maintenance, PSUR , will be unavailable on Wednesday 01 March 2023 between 18:00 and 20:00 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk

22-2-2023

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 1.0.1.6 released to production on 21st of February 2023 are now available on PLM Portal Forum and on the PLM Portal eAF (DADI) web page.

24-1-2022

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 1.0.1.4 released to production on 23rd January 2023 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.

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Updated PLM Portal Guide to Navigation is now available

Please find an updated version of the PLM Portal eAF Guide to Navigation here. The slide is now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.

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eAF - PMS Newsletter Issue 2

We are pleased to inform you that the second edition of the eAF (DADI)-PMS Newsletter is published and available on the EMA corporate website here.

The eAF-PMS Newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities in the EU updates on the progress of the eAF and PMS products.
It also includes an overview of upcoming events and information on available resources.

For more insight on eAF, you are invited to register to the upcoming events and consult the following resources:

Upcoming events:

  • Human Variations eAF Q&A Clinics:
  • Human Variations eAF public training:

    • Q&A documents:

  • General Q&A Document (link), including Q&A's on PMS (Product Management Services);
  • Training Q&A document (link) addressing questions raised by users during earlier eAF (DADI) trainings.
  • Human Variations eAF go-live Q&A session (link).
  • Human Variations eAF go-live training session (8 November 2022) (link).

Please send any questions to eSubProgofficer@ema.europa.eu

21-12-2022

Updated draft eCTD v4.0 implementation timeline for EU now available

An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.

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Updated PLM Portal eAF timeline now available

Please find an updated version of the PLM Portal eAF (DADI) Human Variations Forms timeline. The slide is now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.

And

Updated PLM Portal Guide to eAF (DADI) Registration is now available

An updated version of the Portal (eAF) guide to registration is now available on the PLM Portal Forum and on PLM Portal eAF (DADI) webpage. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes several updates across the document.

For any issues or technical support on PLM Portal, please raise a ticket with the EMA Service Desk portal. Please share any questions with us via eSubProgofficer@ema.europa.eu.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

 
 

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