Navigating The Launch Of ATMPs In Europe

It is crucial for developers of Advanced Therapy Medicinal Products (ATMPs) in Europe to stay updated on regulatory changes and market access dynamics. Starting from January 2025, the EU Health Technology Assessment (HTA) and Joint Clinical Assessment (JCA) regulations will have a significant impact on ATMPs and oncology drugs. Cencora experts Lung-I Cheng, Vice President and Head of Cell and Gene Therapy, and Herbert Altmann, Vice President of Market Access and Healthcare Consulting, provide insights on how to navigate these changes. They discuss the objectives of EU HTA, assessment criteria, and stress the importance of proactive planning and collaboration.

ATMPs face unique challenges due to their genetic-, tissue-, or cell-based nature, complex trial designs, and high costs, making it crucial for developers to understand these regulations.