The EU Joint Clinical Assessment: What It Means for Your Product

From January 2025, the way new medicines are clinically assessed in Europe changed. The Joint Clinical Assessment (JCA) introduces a single, EU-wide evaluation of clinical evidence — and for companies, it reshapes how evidence must be planned long before launch.

The EU Health Technology Assessment Regulation (Regulation (EU) 2021/2282) began applying on 12 January 2025. At its heart is the JCA: a joint, EU-level assessment of the relative clinical effectiveness and safety of a new health technology, carried out once on behalf of all Member States rather than 27 times over.

Who is in scope, and when

The JCA is being phased in by product type:

• From January 2025 — new active substance oncology medicines and advanced therapy medicinal products (ATMPs).
• From January 2028 — orphan medicinal products.
• From January 2030 — all remaining centrally authorised medicines.

The first-ever JCA report — for tovorafenib (Ojemda) in paediatric low-grade glioma — was adopted by the HTA Coordination Group and published in June 2026, with further assessments already in the pipeline.

How it works: the PICO challenge

Each JCA is led by an assessor and co-assessor from two Member States, with input from all 27. Member States submit their national research questions, consolidated into PICO frameworks (Population, Intervention, Comparator, Outcome). Because national comparators and patient populations differ, a single product can generate multiple PICOs — meaning companies must prepare a far broader evidence package than any one national assessment required. Joint Scientific Consultations let developers seek advice on evidence needs before pivotal trials begin.

What JCA does — and does not — decide

The JCA produces a non-binding scientific report on relative clinical effectiveness and safety. It does δεν assess cost-effectiveness, and it does δεν set price or reimbursement. Those decisions remain fully national. Member States must give the JCA report “due consideration,” but each country — including Greece through EOF and the HTA Committee — still runs its own pricing and reimbursement process.

What it means for you

JCA runs on a tight clock in parallel with the EMA marketing-authorisation review, and the multi-PICO burden means evidence generation must anticipate every market’s comparators up front. It harmonises the clinical step but does not replace national negotiations — so early, EU-wide evidence planning is now essential.

Talk to PQRA about your JCA and market-access strategy →