JCA readiness assessment

Inform and transform for JCA

New HTA process requires transformation of internal infrastructure and organization.

Challenging JCA timelines are made feasible with thorough preparation activities and early stakeholder engagement. Take our JCA Readiness assessment, to highlight the unique gaps and advice on the next steps to make sure you are ready for what comes next.

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Joint Clinical Assessment (JCA) aims to harmonise HTA processes across the EU

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.

What does JCA readiness look like?

True JCA readiness goes beyond understanding the regulation itself. It requires early planning, cross-functional alignment, and the ability to anticipate evidence requirements well before pivotal trial design is finalised.

Organizations that are best prepared begin by embedding JCA considerations into market access, HEOR, regulatory, clinical development, and medical affairs planning as early as possible. This includes anticipating likely PICOs, aligning evidence generation strategies to both regulatory and HTA needs, and ensuring internal governance structures can support accelerated submission timelines.

With the first Joint Clinical Assessments now underway and scope expanding to orphan medicines in 2028 and all eligible technologies by 2030, readiness is no longer a future consideration – it is a business-critical capability.

Our JCA Readiness assessment helps identify capability gaps across evidence planning, organisational structure, stakeholder engagement, and submission processes, providing tailored recommendations and practical next steps to strengthen preparedness.