eSubmission Gateway and eSubmission Web Client
The European Medicines Agency’s Gateway and the Submission Web Client are electronic submission channels that allow the applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the Electronic Common Technical Document (eCTD) format. The web-based tool may be more suitable for small and medium-sized companies, but is available for all applicants. The Gateway and the Web Client users will benefit from an automated confirmation of the technical validation feedback and an automated upload to the Agency’s eCTD review system. The use of the eSubmission Gateway and the Web Client is mandatory for all human medicines eCTD submissions since 1 March 2014.
The use of eSubmission Gateway and the Web Client was extended to include all Referral procedures, all Veterinary Medicines submissions including Veterinary Referrals, and to Paediatric submissions such as Paediatric investigation plans, waivers and modifications on 1st of April 2014.
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 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. 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.
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
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.
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.
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.
An updated version of the eSubmission Gateway Web UI will be made available today at 4pm Friday 5th of May. This 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. Please note that the delivery files created prior to the new release for referral and CAP submissions should work following the deployment of the new versions.
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. The users should note that in some cases delivery files created prior to the new release for referral and CAP submissions may not work following the deployment of the new versions.
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. Details are available in the updated Release Notes.
An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version delivers new functionality to create delivery files for MRL and veterinary PSUR submissions as well as functionality to create delivery files for human PASS 107o submissions, PASS 107n, PASS 107o and PASS 107q submissions for Nationally Authorised Products and submissions for Ancillary Medicinal Products in medical devices.
In anticipation of the mandatory use of eSubmission Gateway / Web Client for veterinary submissions to EMA on 1 January 2017, a follow-up Q&A Session for Industry – Mandatory Use of eSub Gateway will be held on 12 January 2017, from 13:00 to 15:00 UK time. For details see the Veterinary esubmission website.
The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 2017.
Use of the XML delivery files for submissions via the eSubmission Gateway and the Web Client is now mandatory. Use of filenaming conventions is only allowed for those submission types where use of delivery files is currently not possible (Ancillary medicinal substances in medical device, PASS 107o, veterinary PSURs and MRLs and number of human and veterinary ASMF submissions). Updated Annex 1 and Annex 2 can be found here.
An updated version of the eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. This new version will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The introduction of this new version marks the end of the successful pilot phase and introduces transitional period to mandatory use of xml delivery files for eCTD submissions from 1 October 2016. The updated delivery files should also be used for eCTD submissions created using eCTD specification version 2.0.
Referral Procedures to be sent via eSubmission Gateway / Web Client from 1st of November 2014
Mandatory use of eSubmission Gateway / Web Client for all eCTD submissions through the centralised Procedure from 1st of March 2014
From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD.
The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission Gateway or Web Client) and the electronic Common Technical Document (eCTD) or NeeS (Non-eCTD electronic Submission) formats for submission of referrals. For Referral submissions related to Centrally Authorised products, it is mandatory to use the eCTD format.
From 1 March 2014, the use of the eSubmission Gateway and/or the Web Client will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the European Medicines Agency (EMA) will no longer accept submissions on CD or DVD. This will apply to all types of procedures, including ASMF submissions. The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. The electronic submission channels offer the following benefits:
easier and quicker way to send electronic submissions securely over the internet with possibility for sponsors to send updates within very short deadlines; feedback to the applicant on the reception of the application and in case of Centralised Procedure eCTD submissions confirmation of the outcome of the eCTD technical validation and the upload to the EMA’s eCTD review system; and no need to submit physical copy of dossier or hard copy cover letter to the EMA. Applicants who have not yet registered are invited to register to use the eSubmission Gateway or the free web-based Web Client solution as soon as possible.
Statements of Intent and announcements