EMA application fees to increase from 1st April 2017

From 1st April 2017, the European Medicines Agency (EMA) will increase fees by 1.2% for all applications made. This increase is in line with the EU inflation rate in 2016.

The European Commission are working to create a regulation for the changes to the fees. Once this regulation is in place, the EMA will use this to adjust their fees and publish full details of the new fees in late March.

All applications made on or before 31st March will be charged the current fees and reduction rates. Applications received after 31st March will be charged the new fees and modified reductions. The fee charged for scientific advice and protocol assistance will depend on the date of validation of the request for advice. Annual fees are reliant on the anniversary date; for those with an anniversary date on or after 1st April, new fees will apply.

This change does not affect the pharmacovigilance services. However, changes to pharmacovigilance fees are expected to be made on 1st July 2017.

Click here to read the announcement.