The eSubmission gateway and web client both include new and improved functionality such as an automated confirmation of the technical validation feedback to the applicant and an automated upload to the Agency's eCTD review system.
The introduction of the improved functionality for the eSubmission gateway and the introduction of the web client are important milestones in the Agency's long term eSubmission strategy which is aimed to provide efficiency gains and cost reductions for all stakeholders. A further step in the eSubmission strategy is the implementation of a secure national competent authority access to the Agency's central repository for online reviewing and downloading of applications. It is anticipated that this will give simultaneous access to dossiers and address the burden related to the distribution of multiple physical copies. It is foreseen that early testing of the prototype will start by the end of second quarter of 2013. More detailed implementation timelines will be subject to a dedicated central repository announcement.
Applicants who have registered and used the web client during the user acceptance testing can continue submitting their applications without further registration in the production environment after 15 January 2013.
Applicants who use the eSubmission gateway or the web client must not submit duplicate submissions with a physical media (CD or DVD) as this might lead to negative technical validation and cause a delay in the processing of the application.
The gateway does not cover applications for veterinary medicines at this stage.
The necessary registration process is detailed at eSubmission gateway and eSubmission web client.