EMA - Regulatory update – All referral procedures to be sent via eSubmission Gateway / Web Client from 1 November 2014

Companies subject to a procedure for human medicines should send all their submissions via the eSubmission Gateway or the Web Client from 1 November 2014. After that date, the European Medicines Agency (EMA) is no longer accepting electronic submissions for referrals on CD or DVD.

The use of the eSubmission Gateway or the Web Client allows companies to submit their documentation to the EMA securely over the internet, thereby improving efficiency and reducing costs. 

The use of the (eCTD) and electronic submission channels, i.e. the eSubmission Gateway or Web Client, has been mandatory since 1 April 2014 for submissions related to procedures for centrally authorised medicines.

For submissions related to procedures for nationally authorised medicines, the EMA is now strongly encouraging companies to make their submissions using the eSubmission Gateway or Web Client in either the eCTD or Non-eCTD electronic submission format. Submissions on CD or DVDs will no longer be accepted.

The use of electronic submission channels offer companies the following benefits:

• easier and quicker way to send eCTD submissions securely over the internet with possibility for companies to send updates within very short deadlines;
• feedback to the sender on the receipt of the submission, the outcome of the eCTD technical validation and the upload to the EMA's eCTD review system;
• no need to submit a physical copy of a dossier to the EMA.

All holders are invited to register to use the eSubmission Gateway or the free web-based Web Client solution as soon as possible.

For more information on the eSubmission Gateway/Web Client go to the eSubmission website.