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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Veterinary eSubmission
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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

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

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


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What's New in eSubmission Today?

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05-11-2019

New version of the eSubmission Gateway XML delivery file now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update has introduced an additional submission unit for PAM submissions and a mandatory selection of yes/no to indicate if a change of MAH is included in a response submission for MAA human and vet. Additionally some minor defects have been fixed.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release deployed in the evening of 4th of November 2019 should continue to work following the deployment of this new version. It is however, recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated system release notes detailing the changes are available here.

Updated annexes to the eSubmission roadmap published

The following updated Annexes to the eSubmission Roadmap have been published to reflect current status of the practical implementation steps. Annex 2 to the HMA eSubmission Roadmap on the Mandatory use of eCTD for all procedure types and Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions. The roadmap and the annexes can be found here.

31-10-2019

Essential maintenance to computer application on Monday evening

The eSubmissions Web User Interface (to create the delivery file) will be unavailable between 17:30-18:30hrs (CET) on Monday, 4 November 2019.

However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, please contact the IT Service Desk."

10-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) is now available. The release v1.23.1.3 is a bug fix release to correct number of issues that affect the forms. Further details are available in the release notes available here. This bug fix release does not affect the Data Exchange Standard (DES).

09-10-2019

Formatted Table Template implementation in the XML delivery files – now live

A new version of the eSubmission Gateway XML delivery file user interface is now available.

Following this release the use of the Formatted Letter template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to provide the Formatted template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.

From 1 January 2020, the Formatted Letter Template will no longer be maintained by EMA. The document and references will be removed from EMA corporate website.

Users are required to fill in all the submissions attributes correctly through eSubmission Delivery File UI by creating an XML delivery file since all attributes in the XML delivery file are used to support important searches in Common Repository. The use of XML delivery files will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release will not work following the deployment of the new version. It is always recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.

The changes are detailed in the release notes here.

Updated version of the PSUR Repository

Updated versions of the PSUR Repository Industry and NCA User Interfaces are now available. There are minor changes to the system and are detailed in the release notes here.

07-10-2019

Essential maintenance to computer applications on Wednesday 09-10-2019

PSUR and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST) on Wednesday, 9
October 2019. However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.  If you have any questions, please contact the IT Service Desk.

01-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) will be available 10 October 2019. The release v1.23.1.3 is a bug fix release to correct a number of issues affecting the forms. More details on the fixes will be available in the release notes which will be published together with the updated forms. This hotfix release does not affect the Data Exchange Standard (DES).
Updated Release Milestone Plan for eAF and updated Release schedule for eAF and CESSP are available here
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Previous news is available here

 

EMA
©1995-2019 European Medicines Agency | Disclaimer | For technical support, please 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