On Tuesday 13 December, the European Commission proposed a revision of the system of fees and charges payable to the European Medicines Agency (EMA), to bring it into line with recent changes to the regulatory framework.
These fees are paid to the EMA by the holders of a market authorisation for a pharmaceutical product. The sums collected enable the EMA to remunerate the national competent authorities for their contribution to the scientific evaluation of pharmaceutical products with a view to their European market authorisation, or for changes to the authorisations of pharmaceutical products already authorised in the EU.
The money collected also funds the pharmacovigilance activities conducted by the EMA for nationally authorised pharmaceutical products.
The proposed changes to the system of fees and charges payable to the EMA aim to update the Agency’s remuneration system following changes to the European pharmaceutical regulatory framework. These changes concern in particular the rules for the authorisation of veterinary products (EU Regulation 2019/6) and the strengthened role of the EMA in crisis preparedness (in particular for the financing of Darwin EU, the Data Analysis and Real World Interrogation Network, from 2024) and to provide the EMA with a real financial basis ensuring that the costs incurred by the EMA are covered.
Link to the proposal: https://aeur.eu/f/4o5 (Original version in French by Émilie Vanderhulst)