EMA Explains Upcoming Fee Increase

Regulatory NewsRegulatory News | 04 March 2019 |  By 

The European Medicines Agency (EMA) on Friday reminded drugmakers that fees payable to the agency are set to increase by 1.7% as of 1 April 2019 to account for inflation in 2018.
The increase will cover all application fees except for pharmacovigilance procedure fees, which EMA says will be revised in 2020 to reflect inflation across 2018 and 2019.
EMA last raised its non-pharmacovigilance fees on 1 April 2018, also by 1.7%, to account for inflation in 2017.
While the fee increase is expected to take effect on 1 April 2019, EMA notes that the increase will not be finalized until the Commission adopts a regulation detailing the increase and publishes it in the Official Journal of the European Union. EMA’s management board will also determine how to implement the fee increases at its upcoming meeting on 21 March.
The agency says it will publish full details of the fee increase at the end of the month following the management board meeting and publication of the regulation.
Editor’s note: This article originally incorrectly stated the fee increase applied to pharmacovigilance fees and has been corrected.


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