Implementation of the New European Health Technology Assessment Regulation

This white paper discusses the implementation of the New European Health Technology Assessment Regulation (HTAR), which mandates that companies with products indicated for cancer treatment or Advanced Therapy Medicinal Products (ATMP) prepare and submit a Joint Clinical Assessment (JCA) dossier. The HTAR, effective from January 2025, aims to unify clinical HTA aspects among EU member states, facilitating the development of medicinal products and high-risk medical devices. The document outlines the timeline for implementation, detailing that orphan drugs will follow in 2028 and all remaining drugs by 2030. It highlights the challenges companies face, including the complexity of the JCA preparation process, which requires extensive data synthesis within tight deadlines. The paper also describes the roles of various subgroups within the EU HTA Coordination Group and emphasizes the importance of early preparation for compliance with the new requirements. ProPharma offers guidance to navigate these changes effectively.