The new EU Health Technology Assessment (HTA) Regulation introduces two key elements: a mandatory Joint Clinical Assessment (JCA) and an optional Joint Scientific Consultation (JSC). This approach aims to harmonize HTA processes across EU member states, streamlining evaluations of new health technologies.
The JCA will focus on relative effectiveness and safety, while the JSC offers early guidance on evidence generation plans and development strategies. This change represents a significant shift in the European regulatory landscape, requiring pharmaceutical companies to adapt their strategies for evidence generation and stakeholder engagement. While promoting consistency and efficiency, the regulation maintains flexibility for national-level economic evaluations and pricing decisions.
This webinar was hosted by Dr Chantal van Gils, VP Evidence and Value and Dr Sigrid Klaar, Medical Advisor and NDA Advisory Board Member.
