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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

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 send@ema.europa.eu

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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