EMA mid-year report 2025

EMA presented results and achievements of its operations for the first half of 2025. Between January and June, applications for new medicines (orphan and non-orphan) remain at the same high level as last year (29 vs 30 applications in Q1-Q2 2024). In veterinary medicines, the Board noted the same high level of applications as in 2024 (12 vs 11 applications in Q1-Q2 2024) and anticipates an increase above the initial forecast for the whole of 2025.

The Board welcomed the positive trend in reduction of company clock stop extensions in Q1-Q2 2025 – an average of 150 days compared to an average of 182 days in 2024 (an approximately 18% reduction). This was achieved thanks to EMA’s initiative to reinforce best practices for requests for clock stop extensions from companies. The overall objective of the initiative is to accelerate access to safe and effective treatments by reducing delays in the approval process.

The 2025 mid-year report will be published on…