How To Successfully Prepare For The HTAR Implementation In The EU

Health technology developers (HTDs) should begin preparations for the upcoming European Health Technology Assessment Regulation (HTAR), set to take effect in January 2025. Initially, this regulation will impact oncology and advanced therapy medicinal products, with orphan drugs following in 2028 and all drugs by 2030. HTAR introduces mandatory requirements that necessitate strategic planning, evidence generation, and stakeholder engagement for successful market access. HTDs must align their internal resources and skills to meet these new standards, particularly in the preparation of Joint Clinical Assessment (JCA) dossiers, which will be required for centralized Market Authorization Applications (MAA).

Key steps for HTDs include introductory training on HTAR rules, conducting technology-specific scoping studies, and defining PICO frameworks for JCA submissions. ProPharma can assist in these areas by offering training sessions and conducting scoping studies to ensure that organizations are well-prepared for the JCA process. Additionally, the implementation of these plans will require careful attention to timelines and budget considerations to facilitate a smooth submission process.

Understanding the full implications of HTAR and the necessary preparations will be crucial for HTDs aiming to succeed in this evolving regulatory landscape. For a comprehensive overview of the HTAR requirements and strategies for effective implementation, access the full article.