04 Dec 2025

On 2 December 2025, the Coordination Group on Health Technology Assessment (HTACG) adopted its 2026 Annual Work Programme, setting out the first full year of joint clinical assessments and joint scientific consultations under the EU Health Technology Assessment Regulation. The plan concentrates on cancer medicines, advanced therapy medicinal products (ATMPs) and a pilot group of medical devices, and details how procedures, governance and IT support will run in practice.

In 2026, joint clinical assessments will primarily concern medicinal products with new active substances for cancer indications and ATMPs, with around 35 oncology assessments and 15 ATMP assessments expected. HTACG may also carry out joint assessments on three variations and about five medical devices, with the first device work planned to start in June 2026. The final numbers will depend on marketing authorisation applications filed with the European Medicines Agency, supported by horizon‑scanning from the Emerging Health Technologies subgroup and inputs from the International Horizon Scanning Initiative.

The work programme confirms that joint scientific consultations will remain fee‑free in 2026, with 8–12 consultations planned for medicinal products and 2–5 for devices. Request windows run from 7 January to 4 February, 1 to 29 April, 3 June to 1 July and 23 September to 21 October 2026 through the HTA IT Platform. No updates of existing joint clinical assessments are foreseen next year.

HTACG and its subgroups will keep their current governance model, with a chair and two co‑chairs – one for medicines and one for devices – until the end of 2028. Plenary meetings will take place in Brussels in February, June and October 2026 in a mixed in‑person/online format, while the joint clinical assessment subgroup will meet one or two times per month, the joint scientific consultation subgroup monthly except August, the methodological and procedural subgroup every two months and the emerging technologies subgroup every three months, mainly online.

Stakeholder interaction will continue through the HTA Stakeholder Network, which is due to meet in person in June and October 2026 and to work virtually on patient and clinician involvement in assessments and consultations. The secure HTA IT Platform will remain the main channel for exchanges with developers and experts and now includes a dedicated European Medicines Agency space.

The Commission’s HTA webpages will provide an overview of ongoing assessments, final reports and anonymised outputs from the 2025 emerging technologies report, alongside regular webinars for developers, patients and clinicians. HTACG also plans to expand horizon‑scanning for disruptive technologies, explore options for future voluntary cooperation under Article 23 of the Regulation and adopt the 2027 work programme by 30 November 2026 after consulting the Stakeholder Network.

Source: Coordination Group on Health Technology Assessment
Link: Annual Work Programme 2026
Date: 2 December 2025