The implementation of the EU Health Technology Assessment (HTA) Regulation has introduced new requirements for market access in Europe, with Joint Clinical Assessment (JCA) becoming mandatory for selected products. As part of this shift, the optional (but strategically valuable) Joint Scientific Consultation (JSC) enables early engagement with HTA bodies to align on evidence expectations before pivotal trials begin.
This summary draws from our webinar held on June 5, 2025, presented by Chantal van Gils and Sigrid Klaar, part of our series Navigating the New EU HTA Regulation with Confidence. The session outlines the structure, timing, and strategic use of JSCs, providing insights into how sponsors can use this process to shape evidence planning, avoid misalignment, and strengthen their position for future JCA procedures.
