Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA

Posted 23 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is announcing its eSubmission Gateway-the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA-is now up and running for all applicants for centralized marketing authorizations.

The program, announced 23 April, was originally launched as a pilot program in January 2012 meant to gauge the usefulness of the electronic submission process.

EMA said in a statement it has seen "an increase in the speed and efficiency of the application process," which had led the agency to determine the program should be opened to all applicants.

EMA is noting physical submissions, such as those on CD- or DVD-based media are still accepted, but will not be accepted if applicants choose to use the eSubmission Gateway.

The agency is also developing a "web-based submission client for low-transmission volumes," which it says will be easier to use for small and medium-sized companies. That program will be launched at the end of 2012.

Read more:

EMA - eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles