EMA Expands Access to Electronic Submission Gateway Pilot to Include Veterinary Products

Posted 27 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) announced 25 April it will expand access to its electronic submission gateway pilot program to include veterinary medicines.

The program, dubbed the eSubmission Gateway, is an "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA.

EMA had recently expanded the program, which was launched as a pilot program in January 2012, to include all human medicines after is saw "an increase in the speed and efficiency of the application process."

For now, the veterinary applications will only be accepted as part of a veterinary spin-off pilot, which is planned to run until July 2012, at which point the program will either expand or be re-evaluated.

Applications will be accepted for veterinary medicines starting 2 May, and applicants will be able to register and apply on EMA's website.

Read more:

EMA - Electronic application form pilot to be extended to initial veterinary applications

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

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