Today, the European Commission publishes the outcome, in the format of a Staff Working Document, of an evaluation of the fee system of the European Medicines Agency (EMA). The outcome of the evaluation indicates that the current fee system of the EMA is generally efficient and effective. However, the acquired experience indicates that it may need to be revised in order to be more flexible to adapt to future developments, including the implementation of the new Veterinary legislation, and also to be more sustainable in the long term.

Based on the outcome of the evaluation, the Commission will examine the impacts of future policy options to update the legal framework on fees. The first step is an inception impact assessment that the Commission publishes for public feedback, to be provided by 16 October 2019.

More information:

For more information on the various fees collected by the EMA, please see the Fee Regulation and the Pharmacovigilance Fee Regulation as well as the EMA web page dedicated to fees.