The EU Joint Clinical Assessment (JCA) is a single clinical assessment of a new health technology, carried out at European Union level under the Health Technology Assessment Regulation (Regulation (EU) 2021/2282). It has applied since 12 January 2025.
A JCA looks at one question. How does the new technology perform against the relevant alternatives, for the patients and outcomes that Member States consider important, and how certain is that evidence?
It does not decide price or reimbursement. Those decisions, together with the economic evaluation, remain national. In Portugal, that means INFARMED and the national HTA process still decide whether and how a medicine is funded by the SNS.
In simple terms, the JCA sets a common European clinical evidence base. Each country then builds its own decision on top of it.
Which products are subject to a JCA?
The Regulation follows a stepwise approach.
- Since 12 January 2025, medicines with a new active substance for the treatment of cancer and advanced therapy medicinal products (ATMPs).
- From 13 January 2028, medicines designated as orphan medicinal products.
- From 13 January 2030, all other medicines within the scope of the Regulation.
Selected high-risk medical devices and class D in vitro diagnostic medical devices can also be assessed. When a medicine already has a published JCA report, a new indication is also subject to a JCA.
The European Commission provides a JCA eligibility checker, and applicants declare in their EMA Letter of Intent whether their application falls within the scope of the Regulation.
How does the JCA process work?
The JCA runs in parallel with the centralised marketing authorisation procedure at the European Medicines Agency (EMA). The main steps are:
- Assessor and co-assessor. The Member State Coordination Group on HTA (HTACG) appoints an assessor and a co-assessor from two Member States.
- Scoping (PICO). The assessment scope is defined through a scoping process that reflects the needs of Member States. It sets the Population, Intervention, Comparators and Outcomes (PICO) to be assessed. Because each country has its own clinical practice, several PICOs may be requested for the same product.
- Dossier. The health technology developer submits a dossier with the requested evidence and analyses. The deadline is 100 days from the first request.
- Assessment and report. The assessors analyse the evidence with input from patients and clinical experts. The HTACG endorses the JCA report no later than 30 days after the European Commission grants the marketing authorisation.
The JCA report describes the relative effects of the technology on the agreed outcomes and the degree of certainty of those effects. It does not contain value judgements or conclusions on the overall clinical added value.
What do Member States have to do with a JCA report?
When a Member State carries out its national HTA on a technology with a published JCA report, it must give due consideration to that report and annex it to the national HTA report.
Member States should also not request again at national level the information, data and analyses that the developer already submitted at Union level.
Each Member State keeps the competence to draw its own conclusions on the clinical added value in its healthcare system. The economic evaluation, pricing and reimbursement stay national.
In Portugal, the new national HTA framework (Decree-Law 118/2026, in force since 1 July 2026) gives INFARMED the role of articulating the national process with the European joint assessments.
Why is the JCA a challenge for companies?
The JCA changes the timing and the scale of the evidence work.
Timing. The JCA runs in parallel with the regulatory review, so the evidence strategy needs to be ready much earlier than for most national submissions.
Scale. A scope with several PICOs can require many analyses, often for comparators that were never tested head-to-head in a clinical trial. This makes systematic literature reviews and indirect treatment comparisons central to the dossier.
Methods. The HTACG adopted methodological guidelines on direct and indirect comparisons in March 2024. Analyses need to follow them and to be transparent about their limitations and uncertainty.
National follow-up. A JCA does not replace national work. Companies still need an economic evaluation, a budget impact analysis and a local value story for each country, aligned with the clinical evidence assessed at EU level.
How can companies prepare?
- Check eligibility early. Confirm whether the product and the planned indication fall within the scope and when.
- Anticipate the PICO. Forecast the populations, comparators and outcomes that Member States are likely to request, including the Portuguese standard of care.
- Map the evidence. Run an evidence gap analysis and a systematic literature review to see what exists and what is missing for each likely comparator.
- Plan the comparative analyses. Decide in advance which indirect comparison methods are feasible, and document the assumptions.
- Connect EU and national work. Make sure the clinical evidence in the JCA dossier is consistent with the economic models and the national submission that will follow.
Frequently asked questions
Does a JCA decide whether a medicine is reimbursed?
No. The JCA is a clinical assessment only. Pricing, reimbursement and the economic evaluation remain national decisions.
Does the JCA replace the national HTA in Portugal?
No. INFARMED must give due consideration to the JCA report in the national assessment, but the national process continues, including the economic evaluation.
What is the role of PICO in a JCA?
The PICO defines what will be assessed. Several PICOs can be set for one product, reflecting the needs of different Member States, and the dossier has to answer all of them.
How long does a developer have to submit the JCA dossier?
100 days from the first request made to the health technology developer.
Final thoughts
The JCA brings a common European clinical assessment, but it also raises the bar on evidence planning. Companies that anticipate the PICO, map their evidence early and plan their comparative analyses will be better placed both at EU level and in the national processes that follow.
At Clevidence, we support organisations with PICO anticipation, evidence gap analysis, systematic literature reviews, indirect treatment comparisons and national HTA and reimbursement submissions in Portugal. See how we supported a full HTA and reimbursement process in Portugal, from the anticipated PICO to the economic evaluation, or learn more about our HTA and market access services.