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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

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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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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.

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

27-03-2020

The EMA has launched a survey to gather information from stakeholders to aid future planning of the development of the Gateway for the Electronic Standards for the Transfer of Regulatory Information (ESTRI).

Considering the European Commission (EC) policy on Digital service infrastructures and the EC recommendation for adoption of the AS4 messaging protocol for electronic exchange of data and documents, we are reviewing the current use of AS1 and AS2 capabilities and the transition expectations on the use of AS4 capabilities.

Please note that the survey has been sent via email to all EU QPPVs who are registered in EudraVigilance and the questionnaire only concerns the users of the AS2 Gateway. Users of the eSubmission Gateway Web Client are not impacted by the potential change of the protocol.

If your organisation has not received the questionnaire, and you are using, or planning to use the Gateway for submissions to the EMA, please contact the us using the service desk. Please note that the deadline for the survey is
3rd of April 2020.

25-03-2020

Updated Guidance on paediatric submissions is now available here. Applicants are reminded that the EMA does not accept submissions that do not follow the published guidance, including the submission channel. EMA encourages applicants who are new to the eSubmission Gateway to submit their application well in advance of the intended deadline.

24-03-2020

Computer application maintenance weekend 28-29 March 2020

Essential maintenance work will be carried out to all Telematics applications as part of EMA’s computer application maintenance work during the last weekend in March.  As a result, e-Submission systems will be unavailable to users between 18:30hrs on Friday, 27th March and 08:00hrs on Monday, 30th March 2020

13-03-2020

Essential maintenance to computer application on Monday morning

eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CET) on Monday, 16 March 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

11-03-2020

The milestones for the CESSP phase 1 project have been updated and can be found here.

 

 

EMA
©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