Today, the Council formally adopted a regulation to modernise and simplify the structure of fees paid to the European Medicines Agency. The new rules will ensure both adequate funding for the EMA and sufficient support for national competent authorities to undertake their scientific evaluation tasks.
Cost-based fees and sustainable EMA operations
The new regulation:
- establishes the transition from a flat-rate to a cost-based fee system
- ensures the sustainability of the European regulatory network formed by the EMA and national competent authorities, providing a sound financial basis to support their operations
- makes the system more flexible and adaptable to future needs, including provisions on updating fees or adapting fees to changing circumstances
- simplifies the existing legislation and merges the content of the two current regulations for pharmacovigilance and non-pharmacovigilance fees into one single legal instrument
Background and next steps
On 13 December 2022, the Commission published a proposal for a regulation revising the existing EMA fee system. After establishing their respective positions, the Council of the European Union and the European Parliament launched negotiations on 5 September and reached a provisional agreement on the final shape of the regulation by the end of the month.
The regulation will now be signed and published in the Official Journal of the EU. It will enter into force on the first day following publication and become applicable on 1 January 2025, repealing the two previous regulations on the EMA fee system.