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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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05-06-2019

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

03-06-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs MAA human and veterinary into web based forms) will be held on 5 June 2019. This webinar is aimed for Regulators and instructions on how to connect have been sent out by email to representatives of National Competent Authorities.

23-05-2019

The presentation and recording from the webinar providing an update to Industry about  the CESSP phase 1 project held on 7th of May 2019 is now available here.

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.

How to login is available here.

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