Based on the outcome of the evaluation of the EMA fee system, the Commission has examined the impacts of future policy options to update the legal framework on fees.
- Impact assessment – Inception impact assessment (EN)
- Impact assessment – Staff Working Document (EN)
- Impact assessment – Staff Working Document Executive Summary (EN)
On 13 December 2022, the Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) No 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 of the European Parliament and of the Council