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Delivery file UI

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eSubmission Gateway

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PSUR Repository
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Industry access

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eCTD

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eCTD v4.0

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EU Module 1

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eSignatures

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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'.

 

RSS news feed


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What's New in eSubmission Today?

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24-03-2017

The Annex 2 of the eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions has been updated to reflect the updated eSubmission Roadmap v2.0 and is now available here.

16-03-2017

Essential IT maintenance to EudraVigilance applications the Weekend of April 1st 2017

Due to essential maintenance between Saturday 1st April 2017 06:00hrs and Sunday 2nd April 2017 23:30hrs (UK time), EudraVigilance Human (for ICSR and Product) and EudraVigilance Veterinary (including EV Web and Gateway) will be unavailable. For any questions, please contact the EMA Service Desk.

08-03-2017

An updated version of the eSubmission Roadmap has been published. The Roadmap has been updated to reflect achieved milestones and to include new and amended timelines for implementation of various telematics systems/standards. The Annexes related to the eSubmission Roadmap will be updated in line of the changes detailed in the roadmap. The updated annexes will be published on the CMB website once available. The updated Roadmap v2.0 and the visual representation of the steps are available here.

23-02-2017

A defect in section 2 of variation eAF causing fields to overlap and an issue affecting the co-rapporteur field in the human MAA form have been detected and subsequently fixed. New version v.1.20.0.5 of the variation and MAA human forms and the updated release notes are now available here. Please note that the Data Exchange Standard (DES) has not changed in this release – the change in the release number reflects that there is no change in the DES. The new versions of the forms can be used as of today and the version 1.20.0.5 will fully replace previous versions on1 March 2017. Please note that there is no change to Renewal and MAA vet forms – the version number 1.20.0.4 will remain for renewal and vet MAA forms.

20-02-2017

An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version delivers a change to the Referral submissions by including information from the Referral cover letter in to the XML delivery file and hence simplifying the submission process and allowing further automation.  Defect fixes have also been implemented. The User guide to the XML delivery file creation and the Release notes have been updated and are now available here

An updated version of the PSUR Repository is now available. This release provides new functionality, changes to the PSUR Repository notifications and defect fixes. The updated NCA User Guide and updated MAH User Guide as well as the updated release notes are available here.

16-02-2017

Essential maintenance to PSUR Repository

PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07.00 and 09.00hrs on Monday, 20 February 2017. However, the Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.

07-02-2017

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.4 – initially called v1.21) are now available. This new release provides usability improvements and defect fixes with an aim to further improve user experience. Please note that the Data Exchange Standard (DES) has not changed in this release – the change in the release number reflects that there is no change in the DES. The updated forms and the related release notes are now available here. The new versions of the form can be used as of today and the version 1.20.0.4 will fully replace version eAF v.1.20.0.3 after a transitional period on1 March 2017. The version of the forms should not be changed during an ongoing procedure.

 

 

Previous news is available here

 

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