Procedural guidance for JCA medicinal products
The JCA, according to Regulation (EU) 2021/2282 (EU HTA), will initially be implemented for oncology drugs and ATMPs in January 2025 and evolve to include rare disease therapies in 2028, with a full roll-out by 2030.
It aims to harmonise processes and evidence requirements, avoid duplication of dossier development for manufacturers, accelerate patient access and focus on comparative effectiveness. The research question for each country will be scoped using a PICO (Population, Intervention, Comparator, Outcomes) survey which will be distributed for completion by all member states. Following confirmation of the PICOs, companies will have 90 days to dossier submission, emphasising the importance of precision planning and operational readiness efforts.
Aside from the ambitious timelines, additional challenges for JCA include
unclear details and rules leaving companies unsure about resource allocation, approval timelines and distribution of responsibilities.
Staged implementation requiring companies and agencies to manage two systems simultaneously for 5 years impacting diverse portfolios and requiring complex resource management
JCA updates are continuously published and Team DC is closely monitoring and evaluating the developments. You can stay informed on the subject by following us on LinkedIn.
