In September 2019, the European Commission published the outcome of an evaluation of the fee system of the European Medicines Agency (EMA). In place since 1995, EMA fees are charged to marketing authorisation holders and applicants for obtaining and maintaining Union-wide marketing authorisations for medicinal products for human and veterinary use.
The outcome of the evaluation indicated that the current fee system of the EMA is generally efficient and effective. However, the acquired experience indicated 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 more sustainable in the long term.
Based on the outcome of the evaluation, the Commission examined the impacts of future policy options to update the legal framework on fees. A proposal to update the EMA fee system was adopted on 13 December 2022.
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. For the Impact assessment and the Commission proposal, please visit this page.
Evaluation of the EMA fee system
Evaluation - Roadmap (EN)
Evaluation - Staff working document (EN)
Evaluation - Executive summary of the Staff Working document (available in EN - FR - DE)
External study supporting the evaluation of the EMA fee system
External study - Terms of reference
External study - Final report (EN)
External study - Summary report (available in EN - FR)
External study - Methodology note (EN)
Further step: Impact assessment and Commission proposal
