What to expect from the EU HTA Regulation in 2026

The Member State Coordination Group on Health Technology Assessment (HTACG) has announced adoption of the 2026 Work Program outlining a major expansion of EU-level joint clinical assessments (JCAs), the first device-focused assessment, and updated governance measures as the EU Health Technology Assessment Regulation enters its second operational year.

The EU Health Technology Assessment Regulation (EU HTAR (EU) 2021/2282), applicable since January 2025, has so far supported ten JCAs and seven joint scientific consultations (JSCs) as part of its inaugural implementation cycle. The newly adopted Work Program indicates a substantial scale-up in activity during 2026, reflecting growing system maturity and deeper coordination across national HTA bodies.

According to the report of the HTACG’s 17th meeting, members reviewed progress on ongoing medicinal product assessments and discussed refinements to assessment scope explanation meetings. The group also considered how to involve individual experts earlier in the process to strengthen the quality, transparency, and consistency of JCA development.

Major expansion of assessments in 2026

Drawing on input from the European Medicines Agency, the International Horizon Scanning Initiative, and the Subgroup for the Identification of Emerging Health Technologies, HTACG estimates that in 2026 it may initiate:

• Around 50 JCAs for medicinal products, including:
• ~35 oncology medicines with new active substances
• ~15 advanced therapy medicinal products (ATMPs)
• ~5 JCAs for high-risk medical devices, with the first assessments expected to begin in June 2026
• 8–12 JSCs for medicines
• 2–5 JSCs for medical devices
• 4 submission windows for developers seeking JSCs throughout the year

The final number of JCAs for medicinal products will depend on valid marketing authorization applications submitted to the EMA between January and December 2026.

New methodological and procedural guidance

Another key focus of the HTACG meeting was the adoption of new guidance documents developed by the Subgroup for Methodological and Procedural Guidance. These include:

• Procedural guidance for JCAs of medical devices and in vitro diagnostic medical devices (MD/IVD)
• Instructions for completing the MD/IVD JCA dossier template
• A consolidated Q&A document addressing methodological and procedural topics such as:
• Individualized treatment comparators
• Dossier submission format
• Evidence expectations for device assessments

Strengthening processes and governance

Additional updates from the HTACG’s discussions include:

• Adjustments to the format and structure of assessment scope explanation meetings
• Measures to involve individual experts earlier in the assessment process
• Adoption of updated governance arrangements, reflecting decisions agreed in 2025

These steps are intended to support a more consistent, transparent, and predictable assessment process as the system scales.

The adoption of the 2026 Work Program marks a significant milestone for the EU HTAR, signaling the transition from early implementation to high-volume, system-wide activity across medicinal products and medical devices.