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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'.

For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here

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What's New in eSubmission Today?

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18-09-2017

Essential maintenance to EMA computer applications affecting PSUR Repository/eSUB UI/eSubmission Gateway on Saturday, 23 September

PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 14:30 on Saturday, 23 September due to essential maintenance. The eSubmission Gateway will be also unavailable between 09:00 and 17:00 (UK time) due to essential maintenance.

15-09-2017

Croatia and Finland are also now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Croatia, Estonia, Finland, Norway and Latvia, as these types of submissions are now retrieved via the Common Repository. More details on the Common Repository can be found on the Common Repository website.

13-09-2017

The Common Repository has been extended to include all human Referral submissions from 1st September 2017. The use of the Common Repository for human Referral submissions will become mandatory for all NCAs on 1st of December 2017. There should be no referral submissions directly to any NCAs from 1st of December 2017 as these will be considered to have been delivered to the NCAs. Please see the Statement of Intent on the mandatory use of Common Repository for human Referral submissions.

Estonia, Norway and Latvia are now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Estonia, Norway or Latvia, as these types of submissions are now retrieved via the Common Repository. Please see details on the Common Repository page.

Applicants and MAHs are reminded that eCTD technical validation reports should not be included within the working documents folder when sending submissions to the EMA via eSubmission Gateway. The EMA does not require any eCTD validation reports as a part of a submission.

The use of the eAF versions 1.21.0.0 for variations and v1.21.0.1 for MAA human and vet and renewals is now mandatory since 1st of September 2017.

Please note that the all support calls relating to eSubmissions systems, such as eAF, must be sent via the EMA service portal. The email addresses ‘eAF@ema’ and ‘eCTD@ema’ are no longer in use and queries sent to these email addresses will not be processed.

01-09-2017

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional attribute ‘PAM code’ in to the XML delivery file. More information on the use of the PAM submission form can be found from the Post-Authorisation Guidance on PAMs; Question: How should I structure my PAM submission dossier? Please note: the PAM submission form should be provided within the eCTD submission package in the same folder as the cover letter (EU M1 section 1.0).

This release of the eSubmission Gateway delivery file UI also fixes the known issue related to submission description ‘Responses to RSI’. The updated User Guide describing the use of the PAM code as well as the updated system release notes detailing the changes are available here.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 1st of September 2017 should work following the deployment of the new version. It is however, recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.

The Common Repository has been extended to contain all human Referral submissions. The use of the Common Repository for referral submissions will become mandatory after a transitional period. The date for the mandatory use for Referral submissions by all NCAs will be announced shortly. The MAHs are advised to review the Dossier Requirements for referral, NAP and ancillary medicinal substances in medical devices document.

Latvia is now using the Common Repository to receive Referral submissions, in addition to all CAP submissions, from 1 September 2017. Please do not send any Referral submissions (including CAPs and NAPs) to Latvia as these are now retrieved via the Common Repository. Please see details on the Common Repository page.

31-08-2017

Essential maintenance affecting eSUB Web User Interface on Friday afternoon

eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:30 and 16:00 on Friday, 1 September 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. If you have any questions, please contact the IT Service Desk.

25-08-2017

Essential maintenance to computer applications on Wednesday morning

Common Repository will be unavailable between 07:00 and 09:00 on Wednesday, 30 August 2017 due to essential maintenance.  If you have any questions, please contact the IT Service Desk.

23-08-2017

The VNeeS Q&A relating to eSubmission for Veterinary Applications has been updated and can be found here.

General FAQ relating to PDF/A has been published on the Veterinary eSubmission page.

15-8-2017

The updated version of the eCTD v4.0 EU M1 Implementation Guide was released for public consultation on 20th May 2017. The commenting period has been extended to allow sufficient time for thorough review by pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities. The new date to submit your comments is 20th of October 2017. Please provide your comments using the comment template to eCTD4consultation@ema.europa.eu.

The eCTD v4.0 working group would like to offer an opportunity for all eCTD tool vendors to discuss open points and ask questions on eCTD v4.0 EU Module 1 Implementation Guide. A face-to-face vendor meeting is planned to take place at BfArM in Bonn, Germany on 6th of October 2017. All vendors are invited, at their own cost to take part. All participants must register in advance, by 22nd September 2017, via email to eCTD4consultation@ema.europa.eu.

The eSubmission Gateway Web Client has been updated in the XCOMP environment. This update introduces updated user interface and improved functionality – users no longer need to manually select the large file applet when sending test submissions using the vgateway in XCOMP environment. Please see the mini user guide for the updated test system here. This new update will be made available in the production environment on 23rd of September 2017 if no issues are detected in testing. The user credentials remain the same in the updated system.

10-08-2017

Essential maintenance of affecting eSubmissions

The EudraVigilance XCOMP Gateway will be unavailable between 09:00 and 17:00 on Sunday, 13 August due to essential maintenance. As part of the exercise, the EMA Production Gateway will be unavailable for 30 minutes at a point between 09:00 and 13:00. In consequence, no Production inbound messages relating to eSubmissions or EudraVigilance will be processed during those 30 minutes and no outbound MDN or ACK messages will be sent. There may also be a very brief interruption to other services as the EMA Production Gateway is brought back online.

12-07-2017

A defect in section 1.4 of the MAA veterinary eAF, affecting the MRL substances has been detected and subsequently fixed. New version v.1.21.0.1 of the MAA veterinary form and the updated release notes are now available.

Defects in section 1 and 3 of the Renewal eAF, affecting the MA Numbers fields and the overages field respectively, have been detected and subsequently fixed. New version v.1.21.0.1 of the Renewal form and the updated release notes are now available.

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 version of the forms should be used as of today. Please note that there is no change to the Variation form – the version number 1.21.0.0 will remain for the Variation form.

04-07-2017

PAM Submission Form is now available. The new form aims to provide a better ‘end to end process’ for PAMs by improving the submission and start phase with greater automation, and by increasing transparency for the Applicant with regards to EMA resources allocated to the procedure, evaluation timetables, and scientific committee assigned.

The full functionality of the PAM Submission Form will be achieved when changes to the eSubmission Gateway are implemented on the 1st of September. From this moment on the new form will be mandatory for all PAM submissions.

Further information will be provided via the post-authorisation procedural Q&A, the eSubmissions webpage and a dedicated regulatory news item closer to the go-live date.

Related information: Post-authorisation measures: questions and answers

30-06-2017

A defect in section 1.1 of the MAA human eAF, affecting the PRAC rapporteur field (Centralised Procedure applications) has been detected and subsequently fixed. New version v.1.20.0.1 of the MAA human form 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 version of the forms should be used as of today. The issue in version 1.21.0.0 does not affect MRP/DCP/NP applications. Please note that there is no change to Variation, Renewal and MAA vet forms – the version number v.1.21.0.1 will remain for variation, renewal and vet MAA forms.

Updated release notes are now available for eSubmission Gateway XML delivery file user interface. The updated document highlights a known issue with submission description ‘Response to RSI’ when submission units ‘initial, validation-response, additional-info, closing, consolidating and corrigendum’ are selected. This defect does not affect the submissions process and will be fixed in the next release.

28-06-2017

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements, new business rules and new fields to the user interface. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect the use of the Formatted Table Template. Release notes detailing the changes are available here.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 27th June 2017 will not work following the deployment of the new version. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.

27-06-2017

Essential maintenance to computer applications on Tuesday afternoon

PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:00 and 17:00 on Tuesday, 27 June 2017. Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 27th June 2017 will not work following the deployment of the new version.

21-06-2017

A presentation on the outcome of the first ‘proof of concept’ UAT on CESSP is now available here.

20-06-2017

Essential maintenance to EMA computer applications affecting PSUR Repository on Saturday, 24 June

PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 19:00 on Saturday, 24 June due to essential maintenance. EMA’s gateway will remain available for all communities throughout and any files submitted during that time will be put in a queue for processing once the deployments have been completed.

If you have any questions, please contact the EMA Service Desk.

And

New versions of the 4 electronic Application Forms (eAF v. 1.21) 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. This new version, 1.21 of the forms can be used as of today (20th June 2017) and will fully replace the version 1.20.0.5 after transitional period, on1 September 2017. Version 1.20.0.5 of the forms will be withdrawn from the eAF website on 20th June 2017 however it may be used until 31st August 2017. The version of the form should not be changed during an ongoing procedure.

15-06-2017

Version 1.21 of the eAFs will be available on 20 June 2017. The release v1.21 provides usability improvements and technical defect fixes. Following a successful User Acceptance Testing (UAT) the release schedule has now available to provide more information regarding the mandatory use of version 1.21.
An updated version of the eSubmission Gateway XML delivery file user interface and the PSUR Repository is planned for Tuesday 27th June 2017. The eSubmission Gateway UI update will introduce improvements to the user interface and new fields. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; 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 27th June 2017 may not work following the deployment of the new versions. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.
An interactive training session introducing the changes on the eSubmission Gateway delivery file will be held on Monday 26th June at 11am UK time. Attendance is on first come first serve basis.

To register to join the training please contact: eSubProgOfficer@ema.europa.eu by Friday 23rd June 2017.

06-06-2017

Essential IT maintenance to EudraVigilance applications the Weekend of June 17th 2017

Due to essential maintenance between Friday, 16th June 2017 17:00hrs and Sunday 18th June 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.

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.

 

 

Previous news is available here

 

EMA
©1995-2017 European Medicines Agency | Disclaimer | For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here