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eSubmission Gateway and eSubmission Web Client
The eSubmission Gateway and the eSubmission Gateway Syncplicity Web Client are electronic submission channels that allow the applicants to submit documents supporting all types of applications for human and veterinary medicines to the Agency securely over the internet in structured and non-structured formats. The web-based Gateway Web Client may be more suitable for small and medium-sized companies, however it 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 and veterinary submissions.
It is mandatory to use XML delivery files for submissions via the eSubmission Gateway and the Web Client.
Previous news is available here
News
10-12-2024
eSubmissions Gateway – naming of the working documents folder
When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.
Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence "0007", which contains working documents, the separate folder should be named "0007-workingdocuments".
More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0.
04-12-2024
Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5
December 2024,
between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common
Repository Web-UI
and API, PSUR Repository Web-UI (both NCA and industry access) and API.
The maintenance includes various improvements and implementations:
- Common Repository Web-UI - technology modernisation
- Gateway XML delivery file user interface - various improvements and integrations for
retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
- Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g.
renaming of the submission mode from "IG" to "super-grouping")
Updated documentation will be published on the relevant pages of the
eSubmission website.
For any further information, please contact EMA Service Desk.
24-10-2024
Planned maintenance of eSubmission systems on 24 October 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Thursday 23 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository XML delivery file UI (relevant for industry only).
Previously created delivery files will continue to work. For any further information, please contact EMA Service Desk.
01-10-2024
Planned maintenance of eSubmission systems on 8 October 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 8 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository Web-UI (relevant for NCAs only).
The maintenance includes the aligning of the VNeeS submission format to 3.1, where applicable, and other small improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.
Updated documentation will be published on the relevant pages of the eSubmission website. For any further information, please contact EMA Service Desk.
27-08-2024
Planned maintenance of the eSubmission Gateway XML delivery file on 2 September 2024
Due to planned maintenance, the eSubmission Gateway XML delivery file will not be available on Monday 2 September 2024, between 18:00 and 19:00. For any further information, please contact EMA Service Desk.
11-06-2024
Planned maintenance of the eSubmission systems on 19 June 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Wednesday, 19 June 2024, between 18:00 and 21:00: Common Repository Web-UI (relevant for NCAs only) and Common Repository API (relevant for NCAs only). During the same interval, the Gateway Filehandler will experience short delays in sending the acknowledgements of the processed submissions.
20-03-2024
Planned maintenance of the eSubmission systems on 25 March 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Monday 25 March 2024, between 18:00 and 21:00: Gateway XML delivery file user interface and Common Repository Web-UI (relevant for NCAs only).
The maintenance includes the introduction of a new field in the eSubmission Gateway XML delivery file user interface (EPITT number for pam-sda submissions), and other small bug fixes and improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.
Updated documentation will be published on the relevant pages of the eSubmission website.
For any further information, please contact EMA Service Desk.
18-01-2023
A new version of the eSubmission Gateway XML delivery file for veterinary Variations Requiring Assessment (VRA) now available
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is available starting with 17 January 2024, 18:00 CET.
This update introduced a split of the submission type VRA to 4 different submission types according to the Timetable as per defined in the Variation Classification document.
The users should note that they should always select the standard timetable (E/S/R) for each scope, regardless of a different TT having been agreed.
For grouped VRA, in the delivery file, the applicant should select the longest timetable applicable to any of the included variations in the application.
Updated release notes and user guidance are published in the relevant section.
Users should note that the delivery files created prior to the new release will not work after the go live.
15-01-2023
A new version of the eSubmission Gateway XML delivery file for veterinary Variations Requiring Assessment (VRA) is planned for release in the evening of 17 January 2024
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is planned for release in the evening of 17th January 2024. This update will introduce a split of the submission type VRA to 4 different submission types according to the Timetable as per defined in the Variation Classification document.
The users should note that they should always select the standard timetable (E/S/R) for each scope, regardless of a different TT having been agreed.
For grouped VRA, in the delivery file, the applicant should select the longest timetable applicable to any of the included variations in the application.
Users should note that the delivery files created prior to the new release will not work after the go live.
And
A new version of the eSubmission Gateway XML delivery file for SEND packages now available
An updated version of the eSubmission Gateway XML delivery file user interface is available starting with 11 January 2024, 18:00 CET. This update introduced in the delivery file for Human submissions the option to specify if there is a “SEND Data package Included”.
Updated release notes and user guidance are published in the relevant section.
Users should note that the delivery files created prior to the new release will not work after the go live.
10-01-2023
Opportunity to submit SEND data packages with new Market Authorisation Applications
From January 2024, EMA is launching a proof-of-concept study to evaluate the added value of using SEND data in the evaluation of new Marketing Authorisation Applications. Applicants are encouraged to submit their SEND data packages, in addition to the eCDT format, as part of their MAA submission. The SEND package must be provided outside the eCTD, inside the working documents folder to avoid eCTD technical validation failure.
An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 11 January 2024, 18:00 CET. This update introduces in the delivery file for Human submissions the option to specify if there is a “SEND Data package Included”.
Users should note that the delivery files created prior to the new release will not work after the go live.
What is SEND?
SEND is the Standard for Exchange of Nonclinical Data between organisations, which provides a standardised format for the submission of nonclinical data to regulatory bodies.
SEND was created by the Clinical Data Interchange Standards Consortium (CDISC) in 2002 to execute on the Study Data Tabulation Model (SDTM) for the submission of nonclinical studies. A SEND dataset package contains the SEND datasets (.xpt files), the Nonclinical Study Data Reviewer's Guide (nsdrg.pdf), and the Define XML Document (define.xml).
Why a proof-of concept?
Standardisation of data presentation has been shown to significantly reduce the time regulators require for reviewing the non-clinical data packages. In this proof-of-concept study, we will evaluate whether using SEND data in the assessment of the non-clinical dossier will lead to improved and more consistent quality of assessments, to more science-driven questions to Applicants, and to faster completion of the non-clinical dossier assessment.
Any questions? Email us at [email protected]
01-12-2023
New submission unit to be used for requesting a Re-examination of an CHMP Opinion
An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 1 December 2023, 18:00 CET. This update introduces in the delivery file for Human submissions the option to choose "Re-examination" submission unit for various submission types. Use this unit for requesting re-examination of opinion for MAA, extension, Type II variation, renewal and annual re-assessment as well as Referral procedures
Please note that regulatory guidance referring to how to send re-examination requests will be updated in the following period. Re-examination requests should be submitted via the eSubmission (Syncplicity) Gateway using eCTD format where required for the procedure type.
06-10-2023
eSubmission Gateway XML delivery file update for Article 18 submissions
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Human submissions (option to choose Article 18 as submission type).
The details on the changes will soon be provided in the updated release notes and the updated user guide. More information on Article 18 can be found
here.
20-06-2023
eSubmission Gateway XML delivery file update for Real World Data
An updated version of the eSubmission Gateway XML delivery file user interface is available starting with 20 June 2023, 18:00. This update introduces a change to the Human Domain only, adding new fields to flag Real World Data/Real World Evidence for selected types of submissions.
The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.
Previously created delivery files should continue to work; however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.
User Guidance
Technical Documents
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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