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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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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.

30-06-2016

eAF: Updated versions of all 4 electronic Application Forms (eAF v. 1.20.0.1) have been published following reported issues with the proof of payment section and entering quantities in the initial human MAA form. The updated forms and related release notes are now available here. Version 1.20 of the forms may be used from 14th June 2016 and will fully replace the current version of eAF v. 01.19 after a transitional period on1 August 2016. Version 1.19 of the forms may be used until 1 August 2016.

PSUR Repository: In some cases, when submitting a package to the PSUR Repository, the zip manager did not create a specific entry for the top level sequence directory. This caused the system to generate an error since it could not match the sequence number provided in the xml delivery file with the top level directory of the zip file.
This issue has now been resolved and, in all cases, the zip manager creates a specific entry for the top level sequence directory. More information on the mandatory use of the PSUR Repository can be found here.

24-06-2016

Variation eAF: Due to an unexpected technical issue the publication of the updated version of the form is postponed to early next week. The hotfix version will be made available as soon as possible during the week commencing 27th June 2016.

ASMF: Updated draft version of the Practical Guidance on the use of the eCTD format for ASMFs for Active Substance Master File Holders and Marketing Authorisation Holders has been released for public consultation and is available here. Please send your comments to EUM1Spec@ema.europa.eu by 29 July 2016.

21-06-2016

Variation eAF: Two issues have been detected with the new version of the variation application form (eAF v. 1.20) affecting the use of the form in its current state for MRP/DCP applications. EMA is currently fixing these defects affecting selection of Reference Member State (MRP/DCP procedures) and the Proof of Payment section. The form may continue to be used for Centralised Procedure applications and National Procedure applications. A new version of the form will be published later this week. If you have already started to fill in the application form v. 1.20 and you are submitting an application prior to the publication of the hotfix version, please provide the information from Proof of Payment section as a separate annex to the application form. Alternatively, you may use version 1.19. Please note that once the hotfix version becomes available the information already filled in v. 1.20 can be imported to the new version.  We would like to thank those users who have reported the issues with the forms.

Important Notice to all PSUR Repository users and MAHs:

The PSUR Repository will be temporarily unavailable from 09:00 – 12:00 (UK time) on Saturday 25  June 2016  due to essential maintenance. All submissions sent to the PSUR repository during the downtime are queued and will be made available in the system once normal service is returned.

14-06-2016

New versions of the electronic Application Forms (eAF v. 1.20) and the related release notes are now available here. This version of the forms provides usability improvements and defect fixes and aims to improve the user experience for all users. Version 1.20 of the forms may be used from 14th June 2016 and will fully replace the current version of eAF v. 01.19 after a transitional period on1 August 2016. Version 1.19 of the forms will be withdrawn from the eAF website on 1 July 2016 however it may be used until 1 August 2016. The use of the eAFs is mandatory for all human and veterinary submissions.

10-06-2016

The use of the PSUR Repository is mandatory as of 13 June 2016.  All PSURs for products authorised in Europe must now be submitted to the PSUR Repository (PSURs for products authorised under Art. 58 are excluded). There should be no PSUR submissions directly to the National Competent Authorities from Monday 13th June 2016 onwards. More information on the mandatory use of the PSUR Repository as well as the updated user guidance is now available here.

07-06-2016

The Data Exchange Standard (DES) for the variation eAF has been updated reflecting changes implemented in the upcoming release of all electronic Application Forms (eAFs) version 1.20 on 14th June 2016. The variation DES and the DES change summary are now available here.

06-06-2016

The interactive Q&A session on the use of the xml delivery files for submissions via eSubmission Gateway scheduled for 6th of June at 10am has been cancelled due to technical issues with Adobe connect tool. A new date will be organised and all registered users will be invited to the session.

01-06-2016

  • An error has been detected in the published md5 checksum and the update is now available here.
  • Updated release notes for the eCTD validation criteria v6.0 and v6.1 are now available here.
  • Updated release notes for the eCTD EU M1 specification v3.0.1 are now available here.
  • All questions, queries and issues on the use of the PSUR Repository should now be reported via the EMA service portal: https://servicedesk.ema.europa.eu. Please indicate in your query that the issue concerns PSUR repository. The introduction of the EMA service portal aims to harmonise the process to report and track queries sent to EMA. The PSURrepository@ema.europa.eu email address should be to submit change requests related to PSUR repository system.
  • Interactive Questions and Answers sessions are being organised on the use of the XML delivery files for all submissions via eSubmission Gateway/Web Client. Please note that both sessions; 1.6.2016 at 12:00 – 13:30 UK time and 6.6.2016 at 10:00-11:30 UK time are on a first come first serve basis, and only the first 200 participants are able to connect to the sessions.

Wherever possible, please share the connection with your colleagues and if you are unable to attend the recordings for both of these Q&A sessions will be published on the eSubmission Gateway website.
Further training and interactive Q&A sessions are planned for July 2016 once a new version of the system is released to reflect the updated EU Module 1 specification.

  • Presentation from the training on the use of the XML delivery files for eSubmission Gateway / Web Client is now available here.
  • The user guide on XML delivery file creation has been updated and is available here.

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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