EMA publishes three-year work plans for five working groups
The European Medicines Agency (EMA) has published three-year work plans for five working groups: Biosimilars, Biologics, joint CHMP/CVMP Quality, Non-clinical domain and Synthetic Peptides, covering the period 2026–2028. The plans outline strategic and tactical goals including advancing regulatory science, harmonising EU and international guidelines, and supporting innovation in medicines development. Key priorities include guidance on biosimilar comparability and tailored clinical approaches, quality aspects for biologicals and RNA vaccines, risk-based strategies for chemical and biological active substances, integration of new approach methodologies (NAMs) and replacement, reduction and refinement (3Rs) principles in non-clinical testing, and publication of a guideline on synthetic peptides addressing manufacturing, characterisation and control requirements.