EU HTA Regulation: Are you Ready for Joint Clinical Assessment?

The new EU Health Technology Assessment (HTA) Regulation introduces Joint Clinical Assessments (JCAs), a single EU-level process for evaluating the clinical value of new medicines.

• Mandatory now for oncology and advanced therapy medicinal products (ATMPs)
• Expanding to orphan drugs and all centrally authorised products from 2028
• One submission, aligned with EMA timelines, no duplication of clinical assessments across Member States

For biotech companies, this means:

• Early integration of HTA into development plans
• Evidence packages that meet both EMA and HTA needs
• Coordinated regulatory and market access strategies

This means thinking about HTA much earlier,  building evidence that fits both regulatory and market access needs from the start.

At tranScrip, we support you across the full development pathway, combining deep regulatory expertise with practical market access strategy. Whether it’s Joint Scientific Consultations (JSCs), evidence planning, or JCA-ready submissions, we’re here to help. > contact us