The European Medicines Agency (EMA) is inviting pharmaceutical companies to register to take part in a three-month pilot of its “eSubmission Gateway” beginning on January 9, 2012.
The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralized marketing authorizations for human medicines in the Electronic Common Technical Document (eCTD) format. This includes new applications, supplementary information, variations and renewals of marketing authorizations.
The Gateway will use a secure business-to-business transfer process to allow companies to send electronic applications to the agency. This is expected to improve the speed and efficiency of the application process, the EMA announcement says.
The pilot will be open to a limited number of applicants. Depending on its results, the agency will consider extending use of the gateway to all applicants.
EMA is also working towards a web-based submission client for low-transmission volumes, which may be more suitable for small and medium-sized companies. It will announce plans for this client in the first quarter of 2012.
Companies interested in taking part in the pilot will need to have access to the Electronic Standards for the Transfer of Regulatory Information (ESTRI) gateway software.
Full details of how to register are available on the eSubmission Gateway web page (see link below).