HTA Regulation: the Coordination Group publishes its 2025 Annual Report

The Member State Coordination Group on Health Technology Assessment (HTACG) has published its 2025 Annual Report, providing an overview of the first year of application of the EU Health Technology Assessment Regulation.

The report presents the key achievements of the HTACG and its four subgroups in 2025, covering joint clinical assessments, joint scientific consultations and the involvement of experts in these cases.

It also covers the work undertaken on the identification of emerging health technologies and the development of methodological and procedural guidance, as well as communication activities with key stakeholders.

Joint Clinical Assessments (JCA) – Key Takeaways

• JCAs are now fully operational and central to the EU HTA system under Regulation (EU) 2021/2282. 
• A single EU‑level clinical assessment of relative effectiveness and safety will be produced and must be used by all Member States as the common clinical basis for national HTA processes. 
• Scope is defined early and strictly (comparators, endpoints, populations), with limited flexibility once the assessment has started. Early decisions are therefore critical. 
• Member States actively participate as assessors and co‑assessors, reinforcing shared ownership but also increasing scrutiny and consistency across countries. 
• Patient and clinical expert input is systematically integrated into the JCA process, influencing scope and interpretation of clinical evidence. 
• Methodological and procedural guidance is expanding, supporting increasing convergence of HTA expectations across the EU. 
• A weak JCA has EU‑wide consequences, as national HTA bodies cannot redo or replace the clinical assessment. 

Joint Scientific Consultations (JSC) – Key Takeaways

• JSCs are a core early‑dialogue tool of the EU HTA framework, designed to address methodological and clinical issues before JCA submission. 
• Demand exceeds capacity: in 2025, 17 requests for medicinal products were received, but only 7 were selected, making JSC access competitive. 
• JSCs focus on key drivers of HTA success, including:
  • choice of comparators
  • endpoints and outcome relevance
  • target population definition
  • management of clinical uncertainty
  • post‑launch evidence generation planning 
• Parallel EMA–HTA consultations are increasingly used, supporting alignment between regulatory and HTA requirements at EU level. 
• HTA bodies, EMA, clinicians and patients are involved, reinforcing the multistakeholder and EU‑wide nature of the advice. 
• JSC advice is non‑binding, but the report clearly positions it as a key instrument to improve the robustness and acceptability of future JCA dossiers.