The European HTA regulation (EU) 2021/2282 came into effect on 1 January 2025. A year later, the Member States’ Health Technology Assessment Co-ordination Group (HTACG) published its first report on the activities carried out to fully implement the new provisions.
The HTA Regulation establishes a structured framework for conducting joint evaluations among Member States, focusing on assessing the value of selected medicines and medtech technologies.
Joint Clinical Assessments (JCAs) are designed to provide a harmonised interpretation of the benefit-risk profile of the involved products, which national authorities can then use to inform decisions on pricing and reimbursement (P&R). The new procedure aims to prevent duplication of efforts in the clinical evaluation of the P&R dossier across Member States.
Joint Scientific Consultations (JSCs) aim to assist developers and sponsors in properly approaching the development of new products to meet requirements to obtain authorisation, thereby shortening the time needed to reach the market. We summarise the main contents of the HTACG’s 2025 Annual report.
The first Joint Clinical Assessments
In 2025, a total of 13 JCAs were initiated: 10 related to new oncology products and 3 to advanced therapies (ATMPs). Among these, six products were specifically aimed at treating rare diseases. One product had two therapeutic indications; another was developed by a research institution, while three products were developed by small and medium-sized companies (SMEs).
By the end of 2025, no JCA dossier had reached the endorsement phase. One dossier was confirmed, while other three were in the process of confirmation by the EU Commission. The remaining dossiers were at earlier stages of the evaluation process.
JCAs are a core component of the new European HTA system. The assessment examines the relative clinical effectiveness and safety of new products (medicines and high-risk medical devices) compared with existing therapeutic options. The assessment of the interested product is carried out by an assessor and a co-assessor from two different countries, who are members of the JCA Subgroup, which held a total of 30 meetings in 2025. Last year, appointed assessors and co-assessors represented 15 European countries, including Norway.
JCAs can be conducted in parallel to the European Medicines Agency’s approval processes, for all new medicinal products falling within the two priority categories mentioned above. The paralell regulatory and HTA evaluations start with the submission of the marketing authorisation application to EMA; the entire process has an average duration of 420 days. In 2025, the HTACG also undertook some preliminary work for the Joint Clinical Assessment of selected high-risk devices and in vitro diagnostics, a task that began in January 2026 with the development of the first recommendation.
Joint Scientific Consultations
Another core activity of the HTACG is Joint Scientific Consultations, which also began in 2025. A total of 17 requests were received during the two planned request periods, all relating to medicinal products. Seven requests were selected for JSC, four of which were associated with EMA-HTA parallel joint scientific consultations. Four procedures involved products seeking orphan designation, plus one ATMP. Two products under consideration were developed by SMEs. Most of the JSCs (3) involved medicinal products for cancer treatment, while other two targeted neurodegenerative diseases. One product was intended to treat a neuromuscular disorder, and another targeted a neurodevelopmental disorder.
At the end of the year, four JSCs were completed, while two were still ongoing, and in one case, it was withdrawn by the developer. JSCs remain a voluntary element of the HTA framework and can be requested by developers seeking advice on how to enhance their clinical development strategies and evidence generation plans to meet the requirements for JCA and national HTA evaluations. JSCs can also run in parallel with the EMA’s Scientific Advice procedure, if the developer requests alignment of regulatory and HTA evidence requirements.
Key topics of the requests received in 2025 included the patient population, the choice of the comparator, the proposed outcomes, and the study design. Some questions related to health economics were also posed. The assessor and co-assessor involved in JSCs are members of the JSC Subgroup and they come from two different countries. Nine countries participated in this activity in 2025. The JSC Subgroup finalised four outcome documents; the average time to complete a JSC was 140 days.
Emerging health technologies
The HTACG is also responsible for the identification of emerging health technologies. In 2025, the EHT Subgroup completed a pilot project to collect relevant data and undertake horizon-scanning activities for both medicinal products and medical devices. The report on emerging health technologies for consideration in 2026 was published in January 2026.
It includes medicinal products whose active substances are intended to treat cancer (61 in total) or that could potentially be regulated as ATMPs, to treat any medical condition. Designations as orphan medicines by the EMA or the FDA (21) or as Priority medicines under the PRIME scheme (6) were also tracked, together with a total of 25 products recognised as ATMPs. Regarding medical devices, 15 products resulted potentially eligible for JCA in 2026.
Methodological and procedural guidance
The consistent implementation of the HTA Regulation also requires the HTACG to develop new methodological and procedural guidelines to support joint work within the subgroups. The guidelines aim to establish common methodological standards for assessing the clinical evidence and outlining the requirements for clinical analysis. All guidelines follow the international standards for evidence-based medicine and are regularly updated. In 2025, efforts in this area primarily focused on guidelines for the JCA and JSC of medical devices and in vitro diagnostics. The HTACG is also responsible for drafting the procedures and templates to be used during the JCA and JSC activities.
Other activities run in 2025
In 2025, the HTACG also aimed to enhance engagement of patients, carers, and clinicians in the planned activities. A dedicated working group within the HTA Stakeholders Network was in charge of developing the process for identifying patients, carers, and clinicians to participate in HTA activities. Over 300 individuals, including patients, carers, or clinicians, were identified. Selected stakeholders participated as experts to the JCA and JSC meetings, offering the patient perspective on the disease burden, the expected treatment outcomes, and still-unmet medical needs. Clinicians additionally provided the clinical expertise relevant to evaluating various technologies. In 2025, a total of 38 patients, carers, or clinicians were involved in JCAs, and 10 in JSCs. Stakeholders also participated in various activities by conducting consultations through the HTA Stakeholders Network.
