Key Takeaways
- The EU HTA Regulation will apply from 12 January 2025, introducing Joint Clinical Assessments (JCA) for innovative therapies.
- By 2028, JCAs will extend to all new Orphan Medicinal Products (OMPs).
- EUCOPE experts will provide practical guidance on the new procedures in a webinar on 15 January 2025.
The EU HTA Regulation is set to transform how new therapies are assessed in Europe. Starting 12 January 2025, the first Joint Clinical Assessments (JCAs) will evaluate the relative clinical effectiveness of innovative cancer therapies and cell and gene therapies approved by the EMA. By January 2028, these assessments will also apply to all newly approved Orphan Medicinal Products (OMPs).
To help stakeholders navigate these changes, EUCOPE is hosting a one-hour webinar on Wednesday, 15 January 2025, at 15:00 CET. Led by experts Alexander Natz and Matias Olsen, the session will detail the procedural rules adopted in 2024 under various Implementing Acts and practical guidance documents from the HTA Coordination Group.
Key Topics and Participation
The webinar will cover Final procedural rules for JCAs under the EU HTA Regulation, Practical steps for compliance with new market launch requirements and Interactive Q&A to address participant questions and concerns.
This session is a vital opportunity for pharmaceutical entrepreneurs and stakeholders to prepare for the impending regulatory changes. The knowledge shared will help ensure smooth compliance with the evolving requirements for introducing innovative therapies to the European market.
EUCOPE (European Confederation of Pharmaceutical Entrepreneurs) represents pharmaceutical companies developing innovative therapies, including orphan drugs and advanced therapies. The organization advocates for balanced, patient-centric regulations across Europe and supports its members in navigating complex legislative landscapes.
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