How the JCA can help sponsors improve clinical studies and global strategies

The Joint Clinical Assessment (JCA) is now mandatory for advanced therapy medicinal products (ATMPs) and oncology products, and soon will be for other products (January 2028 for orphan drugs and January 2030 for all other drugs). Although it presents some uncertainty for sponsors, the JCA can be turned to a clinical and commercial advantage. Having […]

Why the JCA makes early planning and partnerships critical for ATMP sponsors

The Joint Clinical Assessment (JCA) is now mandatory for all new advanced therapy medicinal products (ATMPs). This has huge implications for sponsors, given the unique nature of ATMPs. Navigating the JCA process will therefore require sponsors to think much more carefully about the potential clinical obstacles their product may face in the health technology assessment […]

The why, what and when of the Joint Clinical Assessment

The Joint Clinical Assessment, which came into effect in the European Union in January 2025, represents a fundamental shift in the health technology assessment (HTA) decision-making process. Since 12 January 2025, new oncology medicines and advanced therapy medicinal products (ATMPs) have been subject to the JCA, which is a key mechanism within the Health Technology […]