Billy Amzal, PhD, Head of Strategic Consulting at Phastar, explores the first year of the EU Health Technology Assessment Regulation in a new article for Regulatory Affairs Professionals Society’s Regulatory Rapporteur.
He examines how Joint Clinical Assessments (JCAs) are beginning to reshape how health technologies are evaluated across Europe, the practical challenges faced by national HTA bodies and developers, and what the evolving framework means for patient access to innovative treatments.
‘’While attitudes to the shift are largely positive, there remain real concerns about the practicalities of implementation. Clear communication, support from the EC and the ability of HTA bodies and HTDs to adapt to new ways of working will be crucial to overcome these challenges.’’