Simon-Kucher industry insights: Are pharmaceutical companies ready for EU JCA?

Published on November 3, 2025

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The European Union Health Technology Assessment Regulation (EU HTAR) 201/2282 is reshaping the evaluation process for pharmaceutical products across the EU. As manufacturers navigate this transformation, their preparedness for the EU Joint Clinical Assessment (JCA) remains a critical question. To gain insight into industry readiness, our EU HTA experts conducted in-depth interviews with key industry leaders.

The EU JCA will reshape the pricing and market access (P&MA) landscape across Europe, creating both opportunities and challenges for pharmaceutical companies. As of January 12, 2025, oncology products and ATMPs seeking EMA marketing authorization must undergo this assessment, with orphan drugs expected to follow in 2028 and full implementation for all medicines by 2030.

In this article, we assess…

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