Key Takeaways
- The EU HTA Regulation will take effect on January 12, 2025.
- Joint Clinical Assessments (JCAs) will begin with innovative cancer and cell and gene therapies.
- A webinar on January 15 will provide practical guidance for navigating the new procedures.
From January 12, 2025, the EU HTA Regulation will reshape how new therapies are assessed in Europe. The first Joint Clinical Assessments (JCAs) will evaluate the relative clinical effectiveness of innovative cancer therapies and cell and gene therapies approved by the European Medicines Agency (EMA). By January 13, 2028, these joint assessments will expand to include all new Orphan Medicinal Products (OMPs).
To help stakeholders navigate these significant changes, EUCOPE is hosting a one-hour webinar on January 15, 2025, at 3:00 PM CET. Led by experts Alexander Natz and Matias Olsen, the session will provide an overview of the procedural rules adopted in 2024, outline the steps involved in JCAs, and offer practical insights from the HTA Coordination Group’s guidance documents.
Supporting Stakeholders Through the Transition
Participants in the webinar will gain a deeper understanding of the new processes and have the opportunity to ask questions during a dynamic Q&A session. This preparation is critical for pharmaceutical companies aiming to meet the updated market launch requirements and ensure compliance with the EU HTA framework. EUCOPE encourages all stakeholders to take advantage of this opportunity to stay ahead in a rapidly evolving regulatory landscape.
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