Navigating the EU JCA
Your Go-To Resource for Better Market Access
The EU Joint Clinical Assessment (JCA) is transforming market access for pharmaceutical companies, providing a unified pathway to streamline approvals and accelerate patient access across Europe. This hub brings you everything you need to stay ahead—expert insights, strategies, and the latest updates—so you can navigate the JCA’s evolving regulatory landscape with confidence and achieve better market access across EU member states.
Latest Updates
The EU JCA process starts for new cancer medicines and advanced therapy medicinal products (ATMPs).
Guidance on methodology for PICOs will be adopted, providing detailed methodological guidelines and recommendations for the PICO scoping process.
Publication expected by Q4 2024.
Guidance on procedural steps and timeframe for joint clinical assessments will be adopted, as a methodological supporting document to EU JCA Implementing Acts
Publication expected by Q4 2024.
Guidance on filling in the joint clinical assessment dossier template will be adopted, as a methodological supporting document to EU JCA Implementing Acts.
Publication expected by Q4 2024.
The EU JCA Implementing Act on Joint Scientific Consultations on Medicinal Products for Human Use will be adopted. This act outlines the timelines and key procedural steps for manufacturers seeking guidance to support regulatory and HTA decision-making, following the end of the public consultation period on October 29th, 2024.
The EU JCA Implementing Act on Conflict-of-Interest Rules is adopted, outlining rules for managing conflicts of interest among stakeholders involved in joint clinical assessments, ensuring assessments are conducted in an independent, impartial, and transparent manner.
The EU JCA Implementing Act on Exchange of Information with the European Medicines Agency is adopted, establishing procedural rules for seamless cooperation in information exchange between HTACG, EMA, and experts supporting joint clinical assessments.
The EU JCA Implementing Act on Joint Clinical Assessment of Medicinal Products for Human Use is adopted, outlining the timelines and key procedural steps for the joint clinical assessment of medicinal products.
The EU HTA Regulation is adopted, establishing a new framework for Joint Clinical Assessments of new medicinal products across EU Member States and outlining a phased implementation plan for its adoption.
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- EU JCA & Health Policy Team
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