JCA in the EU: A roadmap for sponsors

The Joint Clinical Assessment (JCA) framework is transforming how new medicines are evaluated across the European Union. Implemented in January 2025 for oncology products and advanced therapy medicinal products, with orphan drugs following in 2028 and other products in 2030, this process creates a single harmonized clinical evidence evaluation for all 27 EU member states.

While JCA streamlines clinical assessments and promotes equitable access to innovative treatments, it can present challenges for sponsors. Companies must navigate multiple PICOs across diverse healthcare systems, manage tight submission timelines, work with limited stakeholder interaction opportunities, and integrate JCA outcomes with national HTA processes.

Our playbook provides practical strategies for success in this new landscape. You'll learn how to conduct early integrated evidence planning, prepare for different JCA outcomes, implement robust data management systems, engage with key stakeholders effectively, and develop flexible economic models that adapt to country-specific requirements.

We share real-world examples of how forward-thinking companies are preparing for JCA implementation, including PICO prediction tools, AI-supported evidence synthesis, and strategic pricing approaches that can accelerate market access across Europe.

Download our complete JCA playbook now to gain valuable insights and actionable guidance for navigating this complex new framework and optimizing your product's path to European patients.

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