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EMA launches eSubmission web tool

Will accept eCTD applications from January 15

The European Medicines Agency (EMA) is continuing to move its marketing authorisation processes online and will shortly begin accepting online submissions through a new eSubmission web client.

The online tool, which is now open for registration, will provide a secure online method for submitting centralised procedure electronic common technical document (eCTD) applications.

The new web client complements the EMA's eSubmission Gateway, which went live last April, but is aimed for applicants with lower transmission volumes.

While use of either the web client or Gateway is not, at this stage at least, mandatory, the EMA said it “strongly recommends” one of them be used for eCTD submissions.

However, physicial media such as CDs or DVDs will continue to be accepted for the time being.

The launch of the web client is part of the EMA's long-term eSubmission strategy, which aims to provide efficiency gains and cost reductions for all stakeholders.

The strategy's next steps will see the EMA work towards providing secure access to its central repository for online reviewing and downloading of applications by national competent authorities.

By giving simultaneous access to dossiers this should address some of the current burdens of distributing multiple physical copies and early testing of a prototype system is expected to have started by June this year.

3rd January 2013

From: Sales, Marketing, Regulatory

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