EU JCA
All you need to know about the latest EU JCA Legislation
The European Union (EU) health technology assessment (HTA) regulation aims to improve the availability of innovative technologies for patients across the EU. It is also suggested that it can enhance efficiency for manufacturers by enabling a single EU-level submission on clinical effectiveness analyses instead of requiring multiple parallel submissions on this evidence to various HTA bodies.1 Starting in January 2025, the regulation outlines the framework for cooperation between the EU Member States for Joint Clinical Assessment (JCA), providing an all-encompassing assessment that addresses the specific needs requested by each Member State.
The final Implementing Act of the EU HTAR for Joint Clinical Assessments of medicinal products — the first legal definition of the procedural and methodological details for the new EU HTAR JCA — was published by the European Commission on March 5, 2024. This initiative was originally launched to assist each Member State in efficiently identifying which major health technologies should be eligible for reimbursement. It has since become law in the European Union and is deemed applicable across all twenty-seven Member States through the principle of direct applicability.
Discover all you need to know about the EU JCA on our this page
Our Resources
e-book – Navigating EU JCA Submissions and Local HTA Decision-Making
Webinar – Real-World Evidence in the Era of EU JCA: How to Target Several Countries with a Single Protocol
