The EU HTA Regulation
Since January 2025, new medicines in scope for the EU joint clinical assessment (JCA) have their clinical evidence assessed once, jointly, by EU member states, instead of separately by each country. Each country still makes its own pricing and reimbursement decisions, but it must take the joint report into account. If your product will reach the EU in the next few years, the decisions that shape your JCA are being made now.
Everything your team needs to understand and prepare for the JCA
The JCA Master Guide
Our JCA Master Guide is a detailed overview of the EU joint clinical assessment: how the process works, the timelines involved, and what is required of manufacturers. It gives your team a clear, shared understanding of the JCA before the work begins.
The guide covers:
The JCA Process
Each stage of a joint clinical assessment, from scoping to the published report
The Timelines
When a JCA starts relative to your EU marketing authorization application, and the key deadlines along the way
The Requirements
What manufacturers must provide, and the rules the submission has to meet
Frequently Asked Questions
What is an EU Joint Clinical Assessment (JCA)? A JCA is a single, EU-level assessment of a new medicine's clinical evidence: how well it works and how safe it is compared with existing treatments. It runs in parallel with the European Medicines Agency's approval process and is required under the EU HTA Regulation.
Which products need a JCA? New cancer medicines and advanced therapies (ATMPs) since January 2025, orphan medicines from January 2028, and all new medicines approved through the EU central procedure from January 2030.
Does a JCA decide price or reimbursement? No. A JCA assesses clinical evidence only and does not include cost-effectiveness. Pricing and reimbursement remain national decisions, but each country must take the JCA report into account.
What is PICO, and why does it matter? PICO stands for population, intervention, comparator, and outcome. Member states submit the PICOs they need, and these define the scope of each JCA. If your trial doesn't address a requested comparator or outcome, that gap will show in the report.
When should we start preparing? Ideally before your pivotal trial design is final. That's when you can still shape comparators and endpoints, and when a Joint Scientific Consultation can give you EU-level HTA advice.
We're a US biotech. Does this apply to us? Yes, if you plan to seek EU marketing authorization through the central procedure for a product in scope. JCA readiness should be part of your global launch planning, not an afterthought.
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Not sure if your product is in scope, or when your JCA will start? Tell us about your product and timeline, and we'll tell you where you stand.