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'.

All comments and feedback on the content of this website should be sent to esubmission@ema.europa.eu.

What's New

03-06-2013

The Implementation guide for the EU Module 1 Specification, version 2.0, EU eCTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0 can be found here. This guidance includes information on submissions during the transitional period.

31-05-2013

The European Commission has published the revised version of the MAA-Human Form (revision 10.1 from April 2013) on 15 April 2013.
Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form.  Applicants should use it starting Monday 3 June 2013.

The electronic version of this application form is now available for use and it can be found here.

24-05-2013

The EU Change Request Tracking table including EU eSubmission Q&A has been updated and is available here

22-05-2013

From 1 March 2014, the use of the eSubmission Gateway and/or the Web Client will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the European Medicines Agency will no longer accept esubmissions on CD or DVD. This will apply to all types of eCTD submissions for human medicines. More information and the statement of intent are available at the eSubmission Gateway and Web Client page .

And

Guidance on How to submit Periodic Safety Update Reports (PSURs) for EU Single Assessment of substances contained in both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) to the European Medicines Agency has been published on the eSubmission Gateway and Web Client page.

19-03-2013

Both eCTD and NeeS validation criteria will be mandatory from 1 September 2013.  During a transition period from 1 July to 1 September 2013, the new validation criteria should only be used for validation of eCTD/NeeS submissions built in accordance with the EU M1 specification v2.0. After 1 September 2013, only submissions compliant with the new validation criteria are accepted (v.5.0 for eCTD and v.4.0 for NeeS). Please refer to the Implementation Guide on the TIGes webpage for the EU module 1, when published.

01-03-2013

The EU Module 1 specification v.2.0, updated DTD and the release notes have now been published. The EU Module 1 v2.0 enables marketing authorisation application in Croatia and can be used from 1 July 2013. A six month period is foreseen from publication of this guidance to upgrade systems that build, validate and review eCTD. It is anticipated that EU Module 1 v2.0 will be required by EMA and National Competent Authorities from 1 September 2013, but precise guidance on transition will be published in due course. Guidance on how to submit information relevant to Croatia from 1 July using EU Module 1 v1.4.1 will be published shortly.

15-01-2013

The European Medicines Agency’s Gateway Release II and the eSubmission Web Client are now live for all applications for Centralised Procedure marketing authorisations for human medicines and can be found here

04-01-2013

A subteam of the TIGes group is working on revisions to the Module 1 specifications and a number of related documents.  This effort is driven by the expected accession of Croatia to the European Union in July 2013.  Thus the DTD must provide for this country to be included in a centralised procedure submission in eCTD format. The team working on the revisions are taking the opportunity to address a number of other pending change requests that effect the Module 1 specification and/or DTD and related documents.  For your information, the pending change requests to be addressed are listed in a streamlined tracking table found here.  Please note that any change requests received by 31 December 2012 will be considered for inclusion in the revisions the team has undertaken.  The form to submit change requests can be found here. Change Requests should be submitted to esub.changerequests@ema.europa.eu