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

About the Webinar

Join our expert for part two of our EU regulatory webinar series.

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 will unpack 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’ll explore how MAHs can position their products for positive JCA outcomes, avoid common pitfalls, and anticipate downstream effects on national pricing and reimbursement.  

Whether you're preparing your first JCA submission or refining your market access strategy for future launches, this webinar will equip you with the tools needed to navigate the new EU HTAR system with confidence. Don't miss the chance to stay ahead in a rapidly changing HTA environment that directly impacts market access across Europe. 

What You’ll Learn

• What the JCA framework looks like under the new EU HTA Regulation 
• Strategic approaches to JCA dossier preparation to maximize European market access success
• Insights into JCA dossier impact on national-level pricing and reimbursement in European markets 

Unable to join? Register and you will receive the recording after the live session.