EU Joint Clinical Assessment Dossier
Pubrica prepares EU Joint Clinical Assessment (JCA) dossiers for companies developing medicinal products within the scope of the EU HTA Regulation. The assessor and co-assessor consolidate PICOs from every Member State and issue them with the dossier request, often several and frequently naming comparators that your trial did not include. The dossier must address all of them from a single evidence base within one hundred days. Pubrica’s JCA writers and evidence synthesis specialists deliver the full dossier, the indirect treatment comparisons it requires and preparation for the national submissions that follow.
- Every consolidated PICO answered, including those your pivotal trial was not designed to address
- Indirect treatment comparisons built where no head-to-head exists, which applies to most comparisons in a multi-PICO scope
- Delivery within the dossier window: 100 days from the Commission’s request, 60 in accelerated procedures and certain variations
- Written for the assessor: the JCA report is limited to clinical evidence, so the dossier contains no economic argument
- National submissions planned from the start, because pricing and reimbursement decisions remain with Member States, which raise their own questions afterwards
All consolidated PICOs answeredIncluded
Indirect comparisons where neededIncluded
Dossier to the template and windowIncluded
Explanation meeting preparationIncluded
Negotiating the PICO scopeNot possible under the regulation
Scope → PICOs → evidence → dossier → 100 days
- Every consolidated PICO answered
- ITCs where no head-to-head exists
- Clinical only, as the regulation requires
- Delivered within the 100-day window
- National follow-up questions anticipated
Deliverables
Four Components of Every JCA Dossier
Each JCA dossier answers several questions from one evidence base. Our specialists address every consolidated PICO in full and report the limits of the evidence where they apply.
From the scopeA scope naming five comparators across three populations is not unusual. A dossier that answers only the comparisons covered by the trial and treats the rest as out of scope is likely to lead to an uncertainty finding.
From the comparisonThe first credibility question an assessor asks is whether the populations are similar enough to compare. Addressing it in the dossier before it is raised helps keep the comparison usable.
From the structureIncluding global value arguments in a JCA dossier weakens the clinical case and presents material that the assessor cannot take into account.
From the processWithout this step, companies may find at submission that they interpreted a comparator definition differently from the assessor who wrote it.
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Compliance and Standards
EU JCA Regulation and Methods Guidance
The EU HTA Regulation sets the requirements, and the methods guidance sets the standard against which the evidence is assessed.
EU HTA Regulation (Joint Clinical Assessment)
In force since 12 January 2025 for new oncology active substances and ATMPs, extending to orphan medicinal products in January 2028 and to all centrally authorised medicines in January 2030. It sets the consolidated PICOs, the 100-day dossier window and the single clinical assessment every Member State must give due consideration to.
PRISMA 2020 (systematic review reporting)
The reporting standard an HTA body expects a submission’s systematic review to meet, including the flow of records, the search reproducibility and the handling of studies excluded at full text.
ISPOR–SMDM good practices (modelling)
The seven-report series on model conceptualisation, state-transition and discrete event structures, parameter estimation, and the validation and transparency expectations that decide whether an HTA committee trusts a model it did not build.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in JCA Dossiers
HTA reviewers examine every part of a submission, so each structural assumption, input and source must be attributable. NICE has published a position on AI use in submissions, and traceability, rather than speed, governs how we use AI tools.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote its own accuracy figures, as they would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our EU JCA Dossier Process Works
Our work begins before the scope is issued, because the period before the 100-day window starts is the only preparation time available.
Scope Anticipation
We map the standard of care across Member States to predict the likely comparators, so that evidence work can begin before the consolidated PICOs are issued.
Scope Review
We read each PICO as written, identify gaps against the evidence base and request an explanation meeting where a definition is ambiguous.
Evidence Development
We update the systematic review, assess the feasibility of each comparison and construct indirect comparisons where no head-to-head evidence exists.
Dossier Writing and Submission
We assemble the dossier to the template, check it for consistency across every PICO and deliver it within the window, with drafts prepared for the national follow-up.
Our Experts
Your EU JCA Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Determines what the work can claim on the basis of the evidence. The subject expert is matched to your topic and tells you clearly when the evidence does not support the intended conclusion.
Responsible for every decision that depends on the numbers. Confirms before analysis begins whether the data can answer the question, and hands over the code so the analysis can be re-run independently.
Identifies the evidence on which the work is based and documents the search so that it can be reproduced. Writes the search strategy line by line for each platform and delivers it dated and reproducible.
Reviews the work independently of the first pass and reconciles the two, because most errors in this work are transcription errors rather than errors of reasoning. All disagreements are logged and adjudicated.
Packages
EU JCA Dossier Packages
Pricing depends on the number of PICOs in the scope and the extent of indirect comparison they require.
JCA readiness assessment
For products approaching filing
Quoted per projectOn indication and evidence base
Delivery By scope
- ✓Standard of care mapped across Member States
- ✓Likely PICOs predicted
- ✓Evidence base tested against each
- ✓Feasibility of indirect comparison assessed
- ✓Evidence gaps reported early enough to address
This is the only stage of a JCA where you control the timetable. If it is completed late, the gaps it identifies can no longer be addressed.
Deliverables Request a quoteFull JCA dossier
For products with a consolidated scope issued
Quoted per projectOn PICO count and comparisons required
Delivery 100 days, or 60 accelerated
- ✓Every consolidated PICO answered
- ✓Systematic review updated to the scope
- ✓Indirect comparisons built and tested
- ✓Dossier written to the template
- ✓Internal consistency checked across PICOs
- ✓Explanation meeting preparation
The dossier window is fixed. Engaging us before the request is issued is more effective than adding resources after it.
Deliverables Request a quoteNational submissions after the JCA
For companies moving from the JCA to national reimbursement submissions
Quoted per projectOn markets and evidence required
Delivery By market
- ✓JCA findings carried into national dossiers
- ✓Country-specific questions answered
- ✓Economic evidence added where the market requires it
- ✓Local comparator and pricing context built
- ✓Consistency with the JCA report maintained
Member States must give the JCA due consideration, but they decide pricing and reimbursement themselves and raise their own questions.
Deliverables Request a quoteSend us the indication and the pivotal trial design, and we will map the likely PICOs at no cost, so that you can see which comparators the dossier may need to address before the window opens.
FAQs
Frequently Asked Questions About the EU Joint Clinical Assessment
If your question is not answered here, please ask an expert. No quote is required.
Since 12 January 2025, the scope has covered medicinal products with a new active substance for the treatment of cancer, and advanced therapy medicinal products.
Orphan medicinal products enter scope in January 2028, and all other centrally authorised medicines in January 2030. Medical devices follow a separate track under the same regulation.
No. The assessor and co-assessor gather Member State input and consolidate the scope, which is then issued with the dossier request.
You can request an explanation meeting where a PICO is ambiguous, and you can predict the likely scope early enough to build evidence for it. We recommend both.
The dossier is due one hundred days after the Commission’s request, or sixty days in accelerated procedures and certain variations.
The final assessment report is endorsed no later than thirty days after the Commission grants marketing authorisation. These timelines are set by the regulation and cannot be negotiated.
No. It replaces the duplicated clinical assessment. Pricing and reimbursement remain national competences and each Member State runs its own process.
Member States must give the JCA report due consideration, but they routinely ask country-specific follow-up questions and expect the evidence to be linked to their own decision framework.
This is the usual situation, and indirect treatment comparison is designed for it: anchored where a common comparator exists, and unanchored where it does not.
The assessor will judge the comparison on whether its assumptions are plausible and tested. A well-specified comparison with clearly stated limitations is more credible than an optimistic one.
Related Services
Related Market Access Services
The clinical assessment is one part of an evidence programme that begins years earlier.
1EVIDENCE SYNTHESIScompleted first
Payer evidence reviewSystematic review and indirect comparison. Health economicsThe economic case for national submissions.2NATIONAL SUBMISSIONSafter the JCA
HTA submission dossierNICE, CDA-AMC, G-BA, HAS, PBAC. Global value dossierA single evidence source for every market.3REGULATORY DOCUMENTSin parallel
CTD module summariesModules 2.4, 2.5 and 2.7. Clinical study reportPrepared to ICH E3 and the source of the clinical evidence.Request a Free PICO Mapping for Your Indication
We will identify the comparators the scope is likely to include before the dossier window opens, while there is still time to prepare evidence for them.