EMA Issues eCTD Reminder to EU Marketing-Authorization Holders

The European Medicines Agency (EMA) issued a reminder Friday to EU marketing-authorization holders that they must use the centralized eSubmission Gateway, or web client, to submit all electronic Common Technical Documents (eCTDs) as of March 1.

After this date, the agency will no longer accept submissions on CD or DVD, the reminder says; the requirement will be applicable to all types of procedures, including active substance master file submissions.

The centralized electronic system is an agency effort to increase efficiency and cut costs for applicants. The quicker, easier and more secure submission process allows the EMA to provide some feedback upon receipt of the documents, as well as confirmation of technical validations, the agency said.

The EMA introduced the electronic submission format in late July of 2012, but did not require drugmakers to submit applications electronically until now. New validation criteria were introduced Dec. 1 of that year.

The gateway can be found at http://esubmission.ema.europa.eu/. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.