For some time now, the EMA has only been accepting the submission of documents in electronic form for the centralised procedure. So far, there have been 2 possibilities to submit documents: either by sending a CD or DVD (in duplicate); or by using the EMA's eSubmission gateway (in the pilot phase) with a limited number of users and restricted functionality. On 23 April, the EMA announced the end of the pilot phase - meaning the release of the complete eSubmission gateway and its unrestricted functionality.
Indeed, the activation of the gateway marks an important milestone towards more efficient processes for the submission, validation and treatment of marketing authorisation dossiers and actually means decreasing costs for the applicant. However, the applicant must first install the required IT infrastructure in his/ her company and assure the compatibility with the electronic standards necessary for the transmission of data which are relevant for the marketing authorisation. These standards are referred to as "ESTRI" (Electronic Standards for the Transfer of Regulatory Information). The set up of ESTRI enables a secure internet-based data exchange service.
The gateway ensures the transmission of all documents related to the authorisation, incl. the CTD, Activ Substance Master Files (ASMFs), Plasma Master Files (PMFs), Periodic Safety Update Reports (PSURs), Variations, Renewals etc. All other submission types such as Referrals, Scientific Advice and Paediatrics are outside the scope of the eSubmissions gateway.
For small and medium-sized companies, the installation of the gateway is not profitable for low transmission volumes. The EMA is currently developing a special gateway client for these companies and this solution should enter the pilot phase by the first quarter of 2013.
The EMA has published the document "EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation" to introduce the thematic of a web-based submission of application via the eSubmission gateway.
The EMA's eSubmission website provides complete information about all aspects regarding the submission of documents in electronic form.
Note: The Conference on "Marketing Authorisation Procedures in the EU" from 16 - 17 October 2012 in Munich, Germany, will deal with the aspects of electronic submission of authorisations.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)