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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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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

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP Dataset Module (AF)

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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Weekend maintenance to eSubmission applications starting 18:00 on Friday 17th 2020

Users should be aware that due to essential maintenance work on EMA’s infrastructure, most of EMA’s computer applications, including most eSubmission systems will experience downtime between the hours of 18:00 on Friday, 17th July and 14:00 on Saturday, 18 July 2020.

Please note that if you have submission deadline for your procedure on Friday, 17th July or Saturday 18th July, you may wish to submit the package prior to the submission deadline to avoid the downtime.

If you have any questions, please contact the IT service desk.

07-07-2020

Computer application maintenance Saturday, 11 July 2020

Essential maintenance work will be carried out to all eSubmission applications as part of EMA’s computer application maintenance work this weekend. As a result, eSubmission systems will be intermittently unavailable between 10:00hrs and 13:00hrs of Saturday, 11 July 2020. If you have any questions, please contact the EMA Service Desk.

29-06-2020

There is a short delay in the start of the UAT for the eAF v1.24.0.0 – new dates will be published very soon. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu 

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An updated version of the User guide to XML delivery file creation is now available here.

24-06-2020

A new version of the eSubmission Gateway XML delivery file now available (medical devices)

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The update has introduced a label change to reflect the new Medical Device legislation.

Users should note that the delivery files created prior to the new release deployed in the evening of 23th of June 2020 will not work after the deployment. It is strongly recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues after the deployment. The updated system release notes detailing the change are available here.

11-06-2020

eAF v1.24.0.0 release milestone plan and updated release schedule for eAF now available

An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available here.

Version 1.24.0.0 of the variation and renewal electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 months transitional period and mandatory use from November 2020. The release v1.24.0.0 will provide a major change into the section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:

The testing by Industry and NCAs is planned to take place as follows:

    • Industry: from Mon 29/06/20 to Fri 03/07/20
    • NCAs*: from Mon 06/07/20 to Fri 10/07/20 (*Based on the eAFs received from Industry)

Please note that these dates are subject to change depending on the outcome of internal UAT. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu 

Further details on the release scope and the confirmed dates for the UAT will be provided soon.

CESP Dataset Module (CESSP Phase 1 Project)

The CESP Dataset Module, previously called CESSP Phase 1 project delivering a replacement of the PDF format electronic Application Forms (eAFs) is currently on hold. Further details and communication will be provided soon.

09-06-2020

A new version of the PSUR Repository (industry and NCA user interfaces now available

An updated version (v1.17.0.0) of the PSUR Repository is now available. There are minor changes to both, the industry and the NCA user interface. There is new functionality for EMA users, and a number of new notifications to different user groups.

Users should note that the delivery files created prior to the new release, deployed in the evening of 9th of June 2020 should continue to work following the deployment of this new version. However, it is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated user guides (MAH and NCA), the PSUR Repository Training Guide for MAHs and NCAs and the system release notes detailing the changes are now available here.

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Essential maintenance to computer application on Tuesday evening

eSubmissions Web User Interface (to create the delivery file) will be unavailable between 18:00-20:00hrs (CEST) on Tuesday, 9 June 2020.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.

03-06-2020

Computer application maintenance – Sunday 7 June 2020

Essential maintenance work will be carried to eSubmission applications as part of EMA’s computer application maintenance work this weekend. As a result, eSubmission applications will be intermittently unavailable to users between 13:00 – 17:00hrs on Sunday, 7 June 2020.

29-05-2020

Please note that there has been an issue with the eSubmission Gateway submissions sent between Thursday 28th 3pm CET until 10am CET Friday 29th of May due to database issues. All submissions sent during this time have failed and the users have received a failure acknowledgement in to their Gateway mailbox. We encourage eSubmission Gateway users to check the mailbox for any failure acks and to resubmit where necessary.  If you require assistance, please  contact EMA service desk.

28-05-2020

The CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralised Procedures has been updated and is available on the eCTD page.

14-05-2020

Essential maintenance to Gateway File Handler on Monday evening

Please note that eSubmission Gateway File Handler will be unavailable between 18.00-20.00hrs on Monday, 18 May 2020 due to essential maintenance. The EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. 

11-05-2020

New versions of the Q&A on how to handle ongoing procedures in relation to mandatory eCTD format and Q&A on mandatory eCTD in National Procedures (NP) are now available here.

05-05-2020

A new version of the eSubmission Gateway XML delivery file now available (Covid-19)

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The update has introduced a new radio button to indicate if the submission is relating to Covid-19. This new flag will help to prioritise and indicate urgency of the incoming COVID19 related submissions.

Users should note that the delivery files created prior to the new release deployed in the evening of 5th of May 2020 should continue to work following the deployment of this new version. However, it is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. The updated user guide and the system release notes detailing the changes are available here.

31-03-2020

In the view that many applicants and MAHs are now working from home due to the Covid-19 situation, we would like to remind the users of the eAF functionality which may facilitate working during exceptional circumstances with variable internet bandwidths.

The electronic Application Forms can be saved directly from the eSubmission website to the users local machine and most fields can be filled in off-line, without access to internet. Only those fields that require substance/term related searches, and the use of OMS for address details requires connection to the internet. Validation feature and most dropdown lists are loaded to the form at the time when the form is opened and can be used even when the user is not connected to the internet enabling most of the form to be filled in without internet connection.

The performance of the forms with regards to the speed is unfortunately not optimal, mainly due to the technology used and the multiple business rules built in to the form, and hence, the network is working hard on the replacement of the PDF format forms with a web-based forms. The new web based forms for human and veterinary MAAs are planned for release later this year (timelines subject to change due to Covid-19 situation).

The eAFs are submitted as a part of the dossier which, for centralised procedure applications, must be submitted via the eSubmissions Gateway. In case the users are experiencing issues with the eAFs or preparing and sending submissions via the eSubmission Gateway or Web Client, we strongly recommend raising a ticket with detailed description of the issue via the EMA service desk portal.

It is important to include as many details as possible of the issue and, for example attaching screenshots or the form in question to aid investigation for the reasons of the issue.

And

The updated VNeeS guideline version 2.7 is now available here and will enter into force on 1st October 2020.

 

 

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©1995-2020 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