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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'.

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What's New in eSubmission Today?

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20-05-2017

An updated version of the eCTD v4.0 EU M1 Implementation Guide is now available for public consultation. The eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to take part in this consultation and provide comments by 30th September 2017. Please provide your comments using the comment template; and any questions regarding further development and clarifications of the released draft documents to: eCTD4consultation@ema.europa.eu. The Implementation Guide and relevant documents can be found here.

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

09-05-2017

Version 1.21 of the eAFs will become available on 20 June 2017. The release v1.21 will provide usability improvements and technical defect fixes.
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 22/05/17 to Fri 26/05/17
    • NCAs*: from Mon 29/05/17 to Fri 02/06/17   (*Based on the eAFs received from Industry)

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

05-05-2017

An updated version of the eSubmission Gateway Web UI will be made available today at 4pm Friday 5th of May. This new version delivers defect fixes and addresses a data protection concern as the application contact person name and contact person contact details are no longer visible in the user interface and the XML delivery file. Details on the defect new fields are described in the updated release notes and the updated User Guide which are available here.

An editorial change has been made to eCTD EU Module 1 specification. The updated EU M1 spec v3.0.2 is available here. There are no changes to the DTD or the validation criteria; and hence this version enters into force as of today and should be used immediately. The users are recommended to use the new version as soon as possible.

04-05-2017

Essential maintenance to computer applications on Friday afternoon

PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15.00 and 16.00hrs on Friday, 5 May 2017. However, the Axway gateway will remain available for all communities and any files affected by the work submitted during that time will be put in a queue for processing when the deployments have been completed. If you have any questions, please contact the IT Service Desk.

19-04-2017

Essential IT maintenance to EudraVigilance applications the Weekend of April 30th

Due to essential maintenance between Friday, 28th April 2017 17:00hrs and Sunday 30th 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.

06-04-2017

Presentation from the training session held on 3rd April 2017 on the use of the updated eSubmission Gateway XML delivery file user interface; and the updated Annex I on the use of the filenaming conventions for eSubmission Gateway are now available here.

A presentation on the Common European Single Submission Portal (CESSP) is available here. The presentation explains the essentials on CESSP with background and details of the project.

eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.2 and the related release notes are available here. There are no changes to the DTD and hence this version enters into force as of today and can be used immediately. The users are recommended to use the new version as soon as possible.
Question and Answer document on the eCTD validation criteria is now available here.

31-03-2017

An updated version of the eSubmission Gateway Web UI is now available. This version delivers new functionality to provide information currently provided in the Formatted Table Template. The aim of this phased implementation is to stop using the template once all relevant fields are available in the XML delivery file. This particular release does not affect the use of the Formatted Table Template. Details on the new fields are described in the updated release notes and the updated User Guide available here. The users should note that in some cases delivery files created prior to the new release on 31st March 2017 for referral and CAP submissions may not work following the deployment of the new versions.

An updated version of the PSUR Repository is now available. This minor release provides defect fixes and corrected business rules. Updated release notes are available here.

The use of the eCTD Specification v3.0.1 is mandatory from 1st April 2017. The EU Module 1 Specification is available here.

The use of XML delivery files for all Veterinary submissions is mandatory from 1st April 2017. See the Veterinary eSubmission page for more information.

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

The scheduled IT maintenance between Saturday 1st April 2017 06:00hrs and Sunday 2nd April 2017 23:30hrs (UK time) to EudraVigilance Human (for ICSR and Product) and EudraVigilance Veterinary (including EV Web and Gateway) has been postponed and the applications will remain available throughout this period. Revised dates will be announced in due course.

29-03-2017

Essential maintenance to computer applications on Friday morning

PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07.00 and 09.00hrs on Friday, 31 March 2017. 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. 

28-03-2017

An updated version of the eSubmission Gateway XML delivery file user interface and the PSUR Repository will be available in the morning on Friday 31st of March 2017. The eSubmission Gateway UI update will introduce new fields for applicants/MAHs to provide submission description and other additional details currently provided on the Formatted Table Template. This change is a first step towards adding this information in the delivery file; however this release does not affect the use of the Formatted Table Template.

Users should note that in some cases delivery files created prior to the new release on 31st March 2017 for referral and CAP submissions may not work following the deployment of the new versions.

An interactive training session introducing the changes on the eSubmission Gateway delivery file will be held on Monday 3rd April at 11am UK time. Attendance is on first come first serve basis. Please join the meeting in the virtual meeting room: https://connect.ema.europa.eu/webinar/

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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