Webinar — Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

As Europe enters a new era of Health Technology Assessment (HTA), the implications of the EU HTA Regulation (EU HTAR) are reshaping how medicines reach patients across the continent.

With the EU HTA Regulation eventually set to apply to all new medicines that are going through a centralized Market Authorization Approval (MAA) at the European Medicines Agency (EMA), Marketing Authorization Holders (MAHs) face a new set of requirements and expectations. For MAHs, this change raises critical questions: How will Joint Clinical Assessment (JCA) submissions impact market access strategies? What evidence and planning will be needed to meet both procedural and evidentiary expectations under the new JCA framework? 

This session unpacks the evolving EU HTAR landscape — from understanding the JCA framework to developing strategies for successful dossier preparation. Through practical insights and real-world considerations, we explore how MAHs can position their products for positive JCA outcomes, avoid common pitfalls, and anticipate downstream effects on national pricing and reimbursement.