Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2022 inflation rate was 10.4%.
The adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2023. Fees charged for pharmacovigilance procedures are expected to be revised by the same percentage later in 2023.
An Explanatory note on general fees payable to the EMA was also published.
Source: Regulatory information – adjusted fees for applications to EMA from 1 April 2023 | European Medicines Agency (europa.eu)