BRIEF—EMA increases its general fees

The European Medicines Agency has announced that general,  non-pharmacovigilance fees payable to EMA by applicants and marketing-authorization holders are increasing by 0.3% and 5.3% as of April 1, 2022, to reflect the inflation rate adjustments of 2020 and 2021, respectively.

Full details of the new fee levels are available in Commission Regulation (EU) 2022/510 amending Council Regulation (EC) No 297/95, its implementing rules, and the corresponding explanatory note on fees, published on March 29, 2022.

These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures.

Every year, the Agency adjusts its fees on April 1, in line with the European Union (EU) inflation rate for the previous year.

The current increase reflects the inflation rate for 2020 and 2021, as published by Eurostat, the EU’s statistical office.