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Delivery file UI

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eSubmission Gateway

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eCTD v4.0

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Introduction

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.

 

RSS news feed


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What's New in eSubmission Today?

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23-05-2016

An eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. The use of the delivery files is initially introduced as a pilot, covering the majority of submission types for both human and veterinary domains. Use of the delivery files will become mandatory for Human Centralised Procedure submissions in line with the mandatory use of the updated eCTD EU M1 in October 2016. The use of filenaming conventions will be phased out after a transitional period for all other procedure types. The user guide to XML delivery files and the release notes are available here.

A webinar on the Introduction to new Gateway User Interface for Veterinary Applicants will be held on 3 June 2016 from 11.30 to 13:00.00 UK time. This webinar is dedicated to Veterinary Industry. Please contact eAFwebinar-registration@ema.europa.eu by 1 June 2016 to register and to send any queries you would like to addressed during this webinar.

19-05-2016

A new release of eSubmission Gateway user interface will introduce use of XML delivery files for submissions via the eSubmission Gateway and the Web Client, replacing currently used filenaming conventions. The use of the delivery files is initially introduced as a pilot, covering the majority of submission types for both human and veterinary domains.

A webinar on the use of the new Gateway User Interface for Applicants for Human medicinal products and PIP sponsors will be held on 23 May 2016 from 10:00 to 11:30 UK time. A meeting invitation to the session with connection details will be sent to all registered Gateway users.

A webinar on the Introduction to new Gateway User Interface for Veterinary Applicants will be held on 3 June 2016 from 11.30 to 13:00.00 UK time. This webinar is dedicated to Veterinary Industry. Please contact eAFwebinar-registration@ema.europa.eu by 1 June 2016 to register and to send any queries you would like to be addressed during this webinar.
Should several participants from the same company wish to attend, it is advised to send only one registration request and attend from the same room. Both sessions will be recorded and the recording will be made available on the eSubmission website.

17-05-2016

Due to am error in the EU M1 specification v3.0, a new version (3.0.1) with the updated md5 checksums is now available here.

13-05-2016

Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. This release provides improvements to the system prior to the start of the mandatory use on 13th June 2016. The release also provides fixes for defects that have been identified during simulated mandatory use. While the new version is being made available the system will not be able to process new submissions. The PSUR Repository will be unavailable for MAH and NCA users between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016. The updated system release notes and MAH and NCA user guides can be found here.

12-05-2016

A series of trainings and Q&A sessions have been scheduled in preparation for the upcoming PSUR Repository release v1.06.00 and for the mandatory use.
The industry representatives are encouraged to register for the training by sending contact details to eSubprogofficer@ema.europa.eu. NCA representatives will receive an invitation from EMA without a need to register.

11-05-2016

The PSUR Repository bulletin has been updated and can be found here.

10-05-2016

Version 01.06 of the PSUR Repository will be made available for both MAHs and NCAs on 14th of May 2016. The new release provides change requests and defect fixes further enhancing the system in preparation for the mandatory use starting on 13th June 2016. While the new version is made available the system will not be able to process new submissions. Submissions will be received via the eSubmission Gateway however will only be made available in the PSUR repository once the deployment is finalised. The PSUR Repository will be unavailable for both, MAH and NCA users between 9:00 am and 9:00 pm UK time on Saturday 14th May 2016. More information on the PSUR Repository can be found here.

03-05-2016

The EU Harmonised technical eCTD guidance has been updated.  The updated document is available here.

Due to the high volume of feedback received for the eAF UAT, the release date has been revised. The updated release schedule is available here.

Annex 1 – A guide to the filenaming convention for eSubmission describing the detailed filenames for submission via the eSubmission Gateway / Web Client has been updated and can be found here.

From 23 May 2016 it will be possible to use XML delivery files instead of existing filenaming conventions for submissions via the eSubmission Gateway / Web Client. Results of the user acceptance testing (UAT) in April were successful and more information on the pilot launch of the XML delivery files for all types of procedures will be published this month.

 

Previous news is available here

 

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