On 1 January 2025, Regulation (EU) 2024/568 on fees and charges came into force. It affects the European Medicines Agency. Such law stipulates that scientific advice fees are waived for entities not engaged in economic activity, including academia. This exemption also applies to protocol assistance and qualification procedure fees, as they are specific categories of scientific advice.

This marks a significant milestone, as financial constraints have often hindered academia’s interactions with regulatory agencies, despite their crucial role in streamlining decision-making on new therapies and methodologies!

Question and answer documents about the new Fee Regulation are also available here.