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eSubmission

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Human eSubmission

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eSubmission CMB

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Documentation

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Projects:

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Common Repository

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CESP
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eAF

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CESSP

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eASMF
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ePMF
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eSubmission Gateway & eSubmission Web Client

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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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NCA 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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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.

11-01-2017

Version 1.21 of the eAFs will become available on 7 February 2017. The release v1.21 will provide mainly technical defect fixes and usability improvements.
We are organising a User Acceptance Testing (UAT) to support the release of this next version of the forms:

  • The testing by Industry and NCAs will take place
    • Industry: from Mon 16/01/17 to Thu 19/01/17
    • NCAs*: from Tue 23/01/17 to Fri 27/01/17   (*Based on the eAFs received from Industry)

If you wish to participate, please email Beatriz.Calvo@ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration.

Please use the Service Desk portal https://servicedesk.ema.europa.eu to raise any queries related to the eAFs. Procedural queries related to MRP, DCP and National procedures should be directed to the relevant National Competent Authority.

 

 

Previous news is available here

 

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