The Joint Clinical Assessment (JCA) is a new cornerstone of the European Union’s efforts to standardize the evaluation of therapies across its member states. As part of the newly implemented Health Technology Assessment (HTA) regulation, this centralized process ensures that medicines are assessed for their relative effectiveness and safety in a consistent manner across all member states. This harmonized system aligns the evaluation of clinical data with the regulatory approval process timeline, creating opportunities to streamline market access while also presenting new challenges. To succeed under the JCA framework, companies must understand its procedural requirements, adapt their evidence generation strategies, and carefully coordinate efforts across internal teams.

This summary is based on the webinar held on the 23rd January, 2025 by our experts Chantal van Gils and Sigrid Klaar, the third installment of our webinar series Navigating the New EU HTA Regulation with Confidence.

Watch the recording below, or download the PDF summary for key steps and takeaways.

Hosts

Dr Chantal van Gils

VP Evidence and Value

Dr Sigrid Klaar

Medical Advisor & NDA Advisory Board member

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