For human medicinal products in the context of the International Conference on Harmonisation (“ICH”) , an electronic exchange standard for the submission of regulatory information by applicants for marketing authorisations for medicinal products to the relevant competent authorities has been developed.

Based on the ICH Common Technical Document (CTD), the ICH M2 Expert Working Group has developed the electronic CTD (eCTD) Specification and released version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and completes it with the European Module 1.

In addition to the continued development and maintenance of the electronic submission standards, and in order properly to implement the eCTD from the perspective of the EMA and National Competent Authorities, there are a number of prerequisites. These include development of the necessary business processes to receive and handle electronic submissions (particularly the eCTD); development of policies particularly those with regard to electronic archiving; and development and implementation of an appropriate technical infrastructure and implementation of systems. Most notable here is the requirement for a tool that will enable Competent Authorities that choose to implement it to receive, validate, store and make available for review marketing authorisation applications and supporting documents submitted electronically by applicants using the eCTD (commonly known as the European Review System or EURS).

For veterinary medicinal products, esubmission guidance has also been developed.

These different initiatives can be encompassed within the general term 'electronic submission implementation'.

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What's New in eSubmission Today?

04-06-2018

Mandatory use of the Common Repository for veterinary submissions

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions is now mandatory since the 1st of June 2018. Please see further details in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)

And

The Common Repository has been extended to include EMA coordinated procedures from 8 March 2018. The use of the Common Repository for EMA coordinated procedures will become mandatory on 1st September 2018.

There should be no EMA coordinated procedures submissions sent directly to any NCAs from 1st of September 2018 as these will be considered to have been delivered to the NCAs. Please see the Statement of Intent on the mandatory use of Common Repository for EMA coordinated submissions for human medicinal products.

01-06-2018

Version 1.23 of the electronic Application Forms (eAFs) will become available on 13 July 2018. The release v1.23 will provide further integration with OMS from SPOR (Organisational/address data) and NTA changes,
User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:

• The testing by Industry and NCAs will take place
• Industry: from Mon 11/06/18 to Fri 18/06/18
• NCAs*:   from Mon 19/06/18 to Fri 22/06/18   (*Based on the eAFs received from Industry)

If you wish to participate, please register by email with eSubprogofficer@ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration. Please follow Summary of changes, document which shows clearly before and after areas and changes to eAF that focus on test scenarios for current UAT. UAT version of Summary of changes will be sent via email with UAT package. Final version will be published on website later (13 July 2018).

16-05-2018

Essential maintenance to computer applications

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 18:00-19:00hrs (UK time) on Thursday, 17 May 2018.  Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF)  will be affected during this time. Should you have any questions please contact the EMA IT Service Desk.

The PSUR Repository will be impacted for industry users sending non-EU single assessment PSURs only and the NCA users using performing searches in the non-EU single assessment area of the PSUR Repository. Search attribute MA authorisation type is also unavailable during this period.  
The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organizations and Locations are used (however manual input of data is allowed for these areas). There is no impact to the Variation application form. All other dropdown menus for controlled terminology continue working during this maintenance activity

15-05-2018

The updated Annexes to the Roadmap are being published as they become available to reflect further details on the practical implementation steps. Annex 1 to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human regulatory submissions can be found here.

And

The updated DES documents and XSD files are now available for all 4 forms under the Technical Documents section. This is in preparation for the scheduled go live of eAF Version 1.23.

Previous news is available here