The Member State Coordination Group on Health Technology Assessment, HTACG, endorsed two further joint clinical assessment reports at its 20th meeting on 22 June 2026, while also recording the first discontinuations of medicinal-product assessments under the EU Health Technology Assessment Regulation.
The European Commission flash report, published on 24 June, states that the Directorate-General for Health and Food Safety congratulated the HTACG on completion of the first published joint clinical assessment and underlined the role of JCA reports in facilitating national pricing and reimbursement decisions. The first report, on tovorafenib, Ojemda, had been published on 9 June.
The HTACG then endorsed by consensus the unredacted JCA reports and summary reports for lurbinectedin, Zepzelca, and tarlatamab, Imdylltra. Both are orphan medicinal products for adults with extensive-stage small cell lung cancer. The endorsed reports will now be submitted to the European Commission for procedural review. If they comply with the procedural rules, the Commission will publish the reports, summary reports and developer dossiers on the Europa portal.
The meeting also adopted the first recommendation for selecting medical devices and in vitro diagnostic medical devices for JCA. The HTACG recommended two implantable medical devices in the circulatory system. Developers with devices and in vitro diagnostic medical devices within the scope of the first recommendation will be informed whether their technology has been recommended.
This step brings the device strand of EU HTA into the operational phase. Earlier HTACG planning indicated that the first device-selection proposal was expected in June 2026 and the June meeting confirms that the selection process has now begun.
The flash report also states that the HTACG discontinued two medicinal-product JCAs after the Commission attested that the developer dossiers failed to meet the requirements in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282. [The products were not identified in the flash report although the Commission’s updated list of discontinued JCAs identifies them as catequentinib, for synovial sarcoma or leiomyosarcoma, and Tacquell, autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded, for melanoma. EMA’s June CHMP agenda listed catequentinib for oral explanation on 24 June; Tacquell subsequently received a negative CHMP opinion on 25 June.]
The discontinuations give the EU process an early example of how dossier quality can affect the JCA pathway. In the first published JCA, the assessment was completed despite substantial uncertainty in the comparative evidence. In these two cases, the issue arose earlier: the submitted dossiers were judged not to meet the Regulation’s requirements, so the EU assessment was discontinued before a report could be produced.
That has consequences beyond EU procedure. The HTACG discussed the implications of a discontinued JCA at national level, while the Commission recalled the legal provisions on re-initiating a JCA under the Regulation. The practical question is what happens when national authorities are expecting a shared EU clinical assessment, but the EU process stops before one is available.
The chair also highlighted early learning from the first JCAs, particularly timelines and the assessment-scope consolidation process. Assessor and co-assessor capacity in the second half of 2026 was also raised, reflecting the movement from initial implementation to a larger JCA workload.
Source: European Commission; EMA; EUCOPE; MedTech Europe
Link:
Flash report published: Member State Coordination Group meeting on 22 June 2026;
List of joint clinical assessments; CHMP agenda for 22-25 June 2026;
Tacquell; EUCOPE on First Joint Clinical Assessment (JCA) Report: Critical Milestone – Readiness for Orphan Drug Assessments Needed;
EU Joint Clinical Assessment for medical technologies – Ready to launch?
Date: 24 June 2026, 25 June 2026 and 2 July 2026
