The European Medicines Agency (EMA) has outlined its 2026 priorities through the annual work plans of its scientific committees, marking a year that will be crucial for regulatory transition and innovation. A central element will be the preparation for the implementation of the new EU pharmaceutical legislation. The Committee for Medicinal Products for Human Use (CHMP) will focus on pre-authorisation activities, initial evaluations, specialised scientific areas and horizontal initiatives, ensuring readiness for the evolving legal framework.
Orphan medicinal products and pharmacovigilance
The Committee for Orphan Medicinal Products (COMP) will continue its evidence-based assessment of orphan designations and maintenance of orphan status. Planned activities also include work on indirect comparisons and the integration of new approach methodologies (NAMs), reinforcing scientific robustness in regulatory decision-making.
Pharmacovigilance will remain high on the agenda. The Pharmacovigilance Risk Assessment Committee (PRAC) will revise Good Vigilance Practices (GVPs) and other guidance documents. Support will also be provided for the use of artificial intelligence and real-world evidence in regulatory pharmacovigilance activities, reflecting the growing role of data-driven approaches in safety monitoring.
The paediatric drugs
The Paediatric Committee (PDCO) will prioritise making paediatric investigation plans (PIPs) more feasible and ensuring the timely completion of development programmes. Activities will include developing therapeutic area strategies and strengthening cooperation with the Clinical Trials Coordination Group (CTCG). The PDCO will also explore innovative ways to generate and use data for marketing authorisation, including the implementation of the ICH E11 guideline on paediatric extrapolation.
Overall, the EMA work plans for 2026 underline a year shaped by regulatory preparedness, methodological evolution and the progressive integration of digital tools into medicines regulation across the European Union.