The new EU Regulation on Health Technology Assessment (HTA) introduces mandatory joint clinical assessments (JCAs) at the EU level for certain medicines and medical devices. As this regulation starts applying from January 2025, it is critical for health technology developers to understand the JCA process and its implications.
Key takeaways
- JCAs will evaluate the relative clinical effectiveness of a product compared to appropriate comparators, focusing solely on clinical data and not economic aspects.
- The scope of each JCA (the PICO - population, intervention, comparator, outcomes) will be defined by EU HTA assessors through a survey of member state needs.
- There could be multiple PICOs requested in a JCA, e.g. to cover different comparators used across member states.
- JCA timelines are tightly coupled to the EMA marketing authorization process, with key milestones defined in the regulation.
Don't miss out on these important details! Read the full white paper to prepare your company for successfully navigating these new mandatory EU-level clinical evaluations.
