The European Union’s Health Technology Assessment (HTA) Regulation, adopted in December 2021 and effective from January 2025, represents a significant change in how Health Technology Developers (HTD) prepare for national HTA submissions and market access. This regulation introduces two main processes: Joint Scientific Consultation (JSC) and joint clinical assessments (JCAs), leading to HTS increased workload under time constraints and uncertainties across various aspects. The regulation aims to streamline decision-making, reduce duplication of efforts, and enhance collaboration among member states, in reality it is centralizing the management of multiple independent submissions (PICOs) aggregated in a single dossier increasing complexity and risk for HTD.

The EU HTA Regulation and its implementation present multiple challenges for HTDs, including, but not limited to, lack of inclusiveness and transparency in processes, low-quality guidance documents developed outside of state-of-the-art practices, lack of applicant guidance, implementation complexity, insufficient resources and expertise to ensure high-quality impartial assessment.

To effectively address these unique challenges, it is crucial to gain a comprehensive understanding of the regulations, assess the technical implications of the guidance, and become acquainted with the templates and their consequences. This approach will enable successful navigation through this complex environment.

Our comprehensive EU HTA training program is designed to equip you with the knowledge and skills necessary to thrive in this new landscape.