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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

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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24-04-2019

A Q&A document on how to handle eCTD for ASMF submissions has been published on the eASMF page.

15-04-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.

Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual meeting room is limited to 200 participants. If multiple users from your organisation are attending, please share the connection with your colleagues.

The webinar will be recorded and the recording will be made available on the CESSP webpage after the webinar.

Please join the webinar in the virtual meeting room on 7th of May at 10:00 CET: https://connect.ema.europa.eu/webinar/
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How to login is available here.

10-04-2019

The eSubmission Gateway and Web Client online registration guidance has been updated with new contact information.  

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The applicants are reminded that eAFs should be edited and signed using Adobe Reader. Using Adobe Acrobat Pro may lead to issues when the regulators review the applications using Adobe Reader and this may lead to validation issues and delays in processing the applications. More information can be found from the eAF Q&A document.

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The slides from the CESSP dataset module training held by the Network Training Centre are available here.

28-03-2019

The release notes for MAA Human and Veterinary electronic Application Forms (eAF) and the Renewal eAF have been updated to reflect new known issues. The release notes are available here.

26-03-2019

eAF dropdown lists not working?

Users are reminded that the eAFs will need to be ‘trusted’ in order for the dropdown lists to work. To ‘trust’ the forms, please click the exclamation mark on the top of the left hand pane and select ‘options’ to open the trust options. Select ‘trust this document always’ to proceed.

18-03-2019

A minor update has been made to the eAF – Questions & Answers document (Questions 9, 13 and 29). The updated version is available here.

15-03-2019

Version 1.23.1.2 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.2 is an unplanned hotfix release to fix 3 issues that affected the functioning of the forms. More details on the fixes are available on the release notes. This hotfix release does not affect the Data Exchange Standard (DES).

This new version (v1.23.1.2) of the forms will fully replace the versions 1.23.1.0 and 1.23.1.1 after transitional period, on 4 April 2019.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.


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The final draft versions of the new XML schemas for the human and veterinary MAA forms that will be used in CESSP phase 1 are now available. The CESSP project is transforming the PDF format electronic Application Forms (eAFs) to interactive web based forms. Please provide your comments on the XSDs to cesspproject@hma.eu by 30th of April 2019.

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The Network Training Centre is organising a webinar on utilising the upgraded XML schema of the initial application forms (eAF MAA human and Vet) to automate application data import into IT systems. The session will be held on 27th March 2019 at 10.30am CET. All relevant NCA staff is encouraged to register for the training on the NTC platform here.

28-02-2019

A minor update has been made to the Q&A on how to handle ongoing procedures in relation to mandatory eCTD format. The updated version is available here.

06-02-2019
The CESP dataset Module Milestones have been published and can be found here.

04-02-2019

Version 1.23.1.1 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.1 is a bug fix release providing usability improvements and technical defect fixes. This bug fix release does not affect the Data Exchange Standard (DES).

This new version (v1.23.1.1) of the forms will fully replace the version 1.23.1.0 after transitional period, on 4 April 2019. The version of the form should not be changed during an ongoing procedure.

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Delay in the Formatted Table Template implementation in the XML delivery files – please continue to use the Formatted Table Template until further notice (Human and Veterinary).


There is a delay in the launch of the Formatted Table Template fields in the eSubmission Gateway Delivery file User Interface (UI) due to interdependencies with other systems, extended testing and resource issues due to the move of the agency. We were therefore unable to discontinue the use of the Formatted Table Template as of 1st of February 2019 as previously announced.

The release of the updated eSubmission Delivery file UI for the eSubmission Gateway has been further postponed until a future date. We will provide an update once the timeline for the delivery can be confirmed.

Please continue to provide the Formatted Table Template for Human and Veterinary submissions as a part of the Cover Letter in Module 1 of eCTD submission sequences or Part 1 of VNeeS dossiers.

As usual, users are required to fill in all the submission attributes correctly through the Delivery file UI. The attributes in the XML delivery files are used to support important searches in the Common Repository and they support EMA internal processes. Please note that incorrect submissions may lead to procedural delays of incoming applications.

 

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