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 mdantory 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 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.
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. Use of filenaming conventions will be phased out after atransitional period for all other procedure types.
PSUR submissions using XML delivery files
Statement of intent for use of xml delivery files for all submissions
From 1 September 2015 all PSURs submissions should be sent with an XML delivery file. After this date, it will no longer be possible to send PSUR submissions using the existing filenaming convention. The exclusive use of the PSUR XML delivery file for PSUR submissions is introduced to harmonise the submission mechanism for all PSURs and will apply to all types of PSUR and PSUR supplementary information submissions. This excludes PSURs for Art. 58 (WHO) procedures.
Referral Procedures to be sent via eSubmission Gateway / Web Client from 1st of November 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.
Mandatory use of eSubmission Gateway / Web Client for all eCTD submissions through the centralised Procedure from 1st of March 2014
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.