JCA for Orphan Medicines

Practical Strategies for Evidence Readiness

How can evidence generation planning be optimised for orphan medicinal products soon to undergo Joint Clinical Assessment (JCA)?

With the remit of JCA expanding to all orphan medicinal products from 2028, the first published JCA reports for orphan medicinal products provide valuable insight into JCA evidence requirements and illuminate some key lessons to be learnt and applied by other manufacturers with upcoming European launches.

In this webinar, our experts shared practical recommendations on JCA evidence planning in the rare disease context, discussing how manufacturers can adapt their evidence generation strategies and strengthen their readiness for the JCA process.

Watch our webinar to find out:

  • What key themes of critique JCA assessors are raising in recent reports for orphan medicinal products
  • How evidence generation planning in the rare disease context should be approached, in light of HTA Coordination Group (HTA CG) requirements
  • How patient and clinical expert input can be used most effectively ahead of the JCA process

Date of recording: 16th September 2026

If you have questions about the webinar or want to explore how these insights apply to your organisation, please Get in Touch with our team today.

With over a decade of experience delivering HTA submissions, value materials and evidence generation activities fully in-house, our talented Value & Access team are ready to support you with your EU JCA activities.

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