The Joint Clinical Assessment (JCA) is a single, EU-level clinical evaluation of a new medicine, run jointly by Member States under Regulation (EU) 2021/2282. It is mandatory for new oncology medicines and ATMPs since January 2025, expands to orphan drugs in 2028 and all new medicines by 2030, and runs on a fixed 100-day clock. One JCA report replaces duplicated national clinical reviews, but national bodies still decide price and reimbursement.
Since 12 January 2025, bringing a new medicine to European patients involves a step that did not exist before: the Joint Clinical Assessment. It is the biggest change to European market access in a generation. This guide explains what the JCA is, how the procedure works, and what it means in practice.
What is the Joint Clinical Assessment?
The Joint Clinical Assessment (JCA) is a single, EU-level assessment of a medicine's relative clinical effectiveness and safety, carried out jointly by EU Member States rather than separately by each national authority. It sits under the European Health Technology Assessment Regulation, Regulation (EU) 2021/2282, often shortened to the HTAR.
Before the HTAR, every country's HTA body reviewed the same clinical evidence on its own, asking many of the same questions in parallel. The JCA replaces that duplicated clinical review with one joint report that every Member State then uses in its national process.
The timeline: who is in scope, and when
The JCA is phased in by medicine type:
- From 12 January 2025: new oncology medicines (new active substances) and advanced therapy medicinal products (ATMPs).
- From 13 January 2028: orphan medicinal products are added.
- From 13 January 2030: all new centrally authorised medicines.
How the procedure runs
A JCA runs alongside the European Medicines Agency (EMA) marketing-authorisation procedure and is built around a fixed clock. The main stages are:
- Scope and PICOs: Member States define the scope using PICOs and the company cannot negotiate it.
- The 100-day dossier: from the first request the developer has 100 days (60 if accelerated) to submit the full Annex I dossier, never later than 45 days before the CHMP opinion. There are no clock stops.
- Completeness check: the Commission checks completeness within 15 working days.
- Assessment and clarifications: assessor and co-assessor draft the report and may send clarification requests on 7-to-30-day deadlines.
- The endorsed report: the Member State Coordination Group endorses the final report, which is then published.
What the report decides, and what it doesn't
This is the most misunderstood part. The endorsed report sets out the relative clinical effectiveness and safety, and its uncertainty, per PICO. It does not rank the medicine, score an added benefit, or recommend a price.
The JCA assesses the clinical evidence. Your national HTA bodies still decide pricing and reimbursement, using the joint report.
Member States must give the JCA report due consideration, but the value judgement and the money decision remain national. A weak or incomplete JCA answer therefore reaches every country at once.
What it means for pharma teams
The JCA turns sequential national submissions into one high-stakes, time-boxed, cross-functional sprint. Regulatory Affairs, Market Access, HEOR, Biostatistics and Medical now share a single deadline and a single source of truth. The hardest parts are the combinatorial PICO scope, the indirect treatment comparisons needed where head-to-head data is missing, and the fact that the clock does not stop.
Run the JCA in one place, on the clock
JCA Studio is purpose-built software for the EU Joint Clinical Assessment: model PICOs by Member State, track evidence gaps, assemble the Annex I dossier and orchestrate the 100-day clock, AI-assisted and EU-hosted.
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