EMA has put in place a rapid scientific advice procedure for potential COVID-19 treatments and vaccines, which is free of charge.
The rapid procedure reduces review time to a maximum of 20 days (from 40-70 days), with no pre-specified submission deadlines.
In addition, flexibility can be agreed on a case-by-case basis on the type and extent of the briefing dossier.
For more information, see:
- Guidance for medicine developers and companies on COVID-19: Accelerated procedures for COVID-19 treatments and vaccines
- EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
- Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
Contact us if you need assistance in preparing such a submission. We will make sure that the documents are diligently prepared so that you can get the most out of such a scientific advice procedure.