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Human eSubmission

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Delivery file UI

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eSubmission Gateway

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PSUR Repository
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eCTD

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eCTD v4.0

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EU Module 1

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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.

 

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What's New in eSubmission Today?

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19-09-2016

A further update to the revised Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions is available here.

The use of the eAF v1.20 will become mandatory on Monday 19th September 2016. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure. The latest version of the forms and relevant guidance is available here.

Essential maintenance to PSUR Repository and the eSubmission Gateway on Tuesday evening 20th September 2016

Please note that the PSUR Repository will be unavailable for Member State and industry users between 18.00-19.00hrs UK time on Tuesday, 20th September due to essential maintenance.  The EMA eSubmission Gateway/Web Client will not be available during this time.

 If you have any questions or issues, please contact the EMA IT Service Desk

19-08-2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.2) have been published following reported issues. The updated forms and related release notes are now available here. Version 1.20 of the forms has been available for use since 14th June 2016 and will fully replace version eAF v. 01.19 after an extended transitional period on19 August 2016. Version 1.19 of the forms may be used until 18 September 2016.

18-08-2016

Recordings from the webinar training on the use of the updated XML delivery files for submissions via the eSubmission Gateway held on 21st July and the interactive Q&A sessions held on 25 and 26th July are now available here.

The recording of the PSUR Repository v1.07 webinar training held on 25 July and recordings from the webinars on the Mandatory use are now available here.

27-07-2016

Common Repository unavailable on Thursday evening 28 July 2016 for scheduled maintenance.
The Common Repository will be unavailable on Thursday 28 July 2016 from 18.00 until 21.00 UK time while scheduled upgrade work is carried out. This upgrade introduces changes to bring the Common Repository into line with eCTD EU Module 1 specification v3.0.

And

The updated release schedule for the hotfix version 1.20.0.2 for electronic Application Forms has been published here. The acceptability of the v1.19.0.2 of the eAF has been extended until 19 September 2016 when the updated versions of all 4 forms plan to be published.

The updated eSubmission Gateway error codes list is now available here. The error codes listing provides problem descriptions for errors experienced by users when sending packages using the eSubmission Gateway / Web Client.

The updated formatted table template is now available here. The main changes in this cover letter template reflect changes in the updated eCTD EU Module 1, the usage of the template for non-EU single assessment submissions and the discontinued use of Annex I for product listing for PSUSA procedures (product listing is created when products are selected on the xml delivery file).

Updated Annex II to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions is available here.

The presentation from the training session on the use of the updated version of the PSUR Repository held on 25 July 2016 is available here.

The presentation from the interactive Q&A sessions held on 25 and 26 July 2016 on the use of the updated version of eSubmission Gateway XML delivery file user interface is now available here.

25-07-2016

Updated versions of the PSUR Repository and the eSubmission Gateway user interfaces to create XML delivery files for submissions via the eSubmission Gateway and the Web Client are now available. These new versions will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The updated delivery files should also be used for eCTD submissions created using eCTD specification version 2.0. The changes are implemented to the Gateway XML delivery files also for Veterinary submissions to align the submission process and provide more information on the submission.

Updated user guides and system release notes are available for PSUR Repository users here and for Gateway users here. Slides from the training session held on 21 July 2016 on the use of the updated delivery files are now available here.

Issues have been reported with the latest versions of the electronic Application Forms v1.20.0.1 and, while the issues are fixed the acceptability of the v1.19.0.0 of the eAF has been extended until 15 September 2016. The new versions of all the 4 forms are planned to be published within the coming weeks, exact date of this new release is yet to be confirmed.

If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.

The formatted table template cover letter has been updated and is now available here.

22-07-2016

Please Note Monday, 25 July 2016 07:00hrs – 09:00hrs (UK time):

The European Medicines Agency will be carrying out essential maintenance activities on the PSUR/eSubmissions Web/Gateway File Handler during the period specified below. Users may therefore find the application being unavailable during this time. However, 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.     

14-07-2016

Updated versions of the PSUR Repository and the eSubmission Gateway user interfaces to create XML delivery files for submissions via the eSubmission Gateway and the Web Client will become available by 1st of August 2016. These new versions will introduce changes in line with the updated EU Module 1 Specification v3.0. The changes are implemented to the Gateway XML delivery files also for Veterinary submissions to align the submission process and provide more information on the submission.

Invitations to training sessions and interactive Q&A sessions have been sent to registered Gateway users and contact points who have previously attended PSUR Repository training. If you have not received an invitation and would like attend, please register by contacting eSubProgOfficer@ema.europa.eu by Wednesday 20th July noon UK time.

The maximum capacity of the virtual meeting rooms is 200 participants and spaces will be allocated on a first come first serve basis. There are 2 separate Q&A sessions to allow as many participants as possible to attend this interactive session. The participants should select one of the sessions only.

If multiple users from your organisation intend to attend, please consider sharing the connection with your colleagues. Sessions will be recorded and the recordings will be made available on the eSubmission website.

Session

Date

Time

Training on the use of XML delivery files for submissions via the eSubmission Gateway – update reflecting the updated EU M1.

Thursday 21 July 2016

09:00 UK time

Training and Interactive Q&A on the v1.07 of the PSUR Repository

Monday 25 July 2016

10:00 UK time

Interactive Q&A session on the use of the XML delivery files for submissions via the eSubmission Gateway (session 1)

Monday 25 July 2016

12:00 UK time

Interactive Q&A session on the use of the XML delivery files for submissions via the eSubmission Gateway (session 2)

Tuesday 26 July 2016

10:00 UK time

Updated Release Notes and Implementation Guide have been published to clarify the changes and requirements related to the update of the eCTD EU Module 1 Specification v3.0 and v3.0.1. Both documents can be found from here.

Updated Release Notes have been published to provide clarification on the changes and the use of the eCTD Validation Criteria v6.1. The updated document can be found here.

Issues have been reported with the latest versions of the electronic Application Forms v1.20.0.1 and, while the issues are being investigated and fixed, new versions of all the 4 forms are planned to be published within the next coming weeks, exact date of this new release is yet to be confirmed. If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.

04-07-2016

ASMF: It is now mandatory to use eCTD format for all ASMF submissions for human use in the centralised procedure.

eCTD: The EUM1 Specification v3.0 and v3.0.1 have entered into force on 1st July 2016 and may be used for all eCTD format submissions within Europe.Submissions in v2.0 will be accepted until 30th September 2016.

VNeeS: An updated version of the VNeeS checker version 2.4.b has been published on the websites of the French and Belgian competent authorities. More information on the update and information on the veterinary eSubmissions can be found here.

eSubmission Gateway: Presentation and recording from the webinar training on the use of XML delivery files for Veterinary submissions via the eSubmission Gateway, held on 3 June 2016, are now available here.

The recordings from the training session and the interactive Q&A session on the use of XML delivery files for submissions via the eSubmission Gateway are now available here.

 

Previous news is available here

 

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