The European Medicines Agency (EMA) has released its February 2025 Human Medicines Highlights newsletter, marking its 30th anniversary.
Key Updates:
- The newsletter reflects on the EMA’s evolution since 1995 and emphasises its commitment to patient and stakeholder collaboration. Please click here for more information.
- Clinical Trials Regulation: as of 31 January 2025, the EU Clinical Trials Regulation is fully applicable, concluding a three-year transition. This aims to streamline clinical trial processes and bolster Europe’s appeal for clinical research. Please click here for more information.
- European Shortages Monitoring Platform (ESMP): the ESMP is now operational, enhancing the monitoring and management of medicine shortages within the EU. Please click here for more information.
- Azole Resistance Report: a joint report by EU health and environment agencies highlights that extensive azole fungicide use, particularly in agriculture, contributes to resistance in Aspergillus fungi. The report advocates for a ‘One Health’ approach to address this issue. Please click here for more information.
- Anti-Falsified Medicines Campaign: throughout February, the EMA, in collaboration with Europol and the European Union Intellectual Property Office, is conducting a social media campaign to raise awareness about the dangers of purchasing falsified medicines from unregistered pharmacies. Please click here for more information.
- Overview of human medicines in 2024: theEMA recommended 114 medicines for marketing authorisation in 2024, of which 46 had a new active substance never before authorised in the EU. This document gives an overview of EMA recommendations in 2024. Please click here for more information.
- Medicine Approvals: the EMA has issued a positive opinion for Slenyto (melatonin) for the treatment of insomnia in patients with attention-deficit hyperactivity disorder. Please click here for more information
