EU Joint Clinical Assessments (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.
This regulation outlines the framework for cooperation between the EU Member States for JCA, providing an all-encompassing assessment that addresses the specific needs requested by each Member State.
The final Implementing Act of the EU HTA regulation for JCA 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.
Our Resources
Webinar – Navigating the First Year of EU JCA Implementation: Updates, Methodological Insights, and Bridging Local HTA Realities
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
We help sponsors prepare for JCAs
Our global teams are well-versed in preparatory actions for JCAs. Request a consultation below.
