EMA: EU Council gives final green light to the overhaul of its fee system

Brussels, 23 January 2024

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.

During the last years, the European Medicines Agency and the national competent authorities have worked hard and ceaselessly to ensure safe vaccines and medicines for all EU citizens throughout the COVID-19 pandemic and in its aftermath. The new regulation and the new fee system will further support their operations and tasks.

Frank Vandenbroucke, Belgian Deputy Prime Minister and Minister for Social Affairs and Public Health

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.

• Regulation on fees and charges payable to the European Medicines Agency
• Voting results
• European Medicines Agency: Council and Parliament strike deal on a sustainable and flexible fee system (press release, 25 September 2023)
• Key measures in health policy (background information)

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Source – EU Council