The EU HTA Regulation is now live, and the Joint Clinical Assessment is reshaping how evidence is judged across Europe. The companies that prepare early — not at launch — will move from approval to patient access fastest.
The Joint Clinical Assessment (JCA) delivers one EU-level evaluation of a medicine’s relative clinical effectiveness and safety. But it does not set price or reimbursement — each country, including Greece, still runs its own process. Success means preparing for both the joint and the national stages at once.
A practical roadmap
- Start early with scientific advice. Use Joint Scientific Consultations to align your evidence plan with HTA expectations before pivotal trials are locked.
- Map every market’s PICO. Because Member States define their own populations and comparators, anticipate the full set of PICOs and generate comparative evidence to match — including indirect comparisons where head-to-head data are missing.
- Align EMA and HTA evidence needs. Regulatory approval and clinical assessment run on parallel clocks; build one evidence strategy that satisfies both.
- Plan the national dossier in parallel. Translate the JCA outcome into a country-ready submission — for Greece, an EOPYY/HTA Committee dossier with the local economic analysis and value story.
- Prepare for the phased scope. Oncology and ATMPs are already in scope; orphan medicines follow in 2028 and all centrally authorised products in 2030. Know when your portfolio is affected.
Why it matters
The JCA harmonises the clinical step but adds a heavier, earlier evidence burden. Companies that treat it as a launch-time formality risk deficiencies and delay; those that plan the joint and national pathways together protect their timelines.
How PQRA helps
PQRA guides companies through the full EU HTA journey — from evidence planning and JCA readiness to the Greek national reimbursement submission — so the path from approval to access is as short and predictable as possible.
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