EU HTA Regulation Implementation · July 16, 2026

EU HTA Regulation: JCA reports and procedural guidance

Original title: JCA reports

Collection of joint clinical assessment reports, procedural guidance for joint scientific consultations on devices and IVDs, and methodological Q&As for HTA dossier preparation.

High obligation Framework Market Access & Reimbursement Medical Devices & IVD Clinical Trials & Research EU-wide Health technology assessmentClinical evaluationIn vitro diagnostics

Joint Clinical assessment report on onasemnogene abeparvovec (Itvisma) General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier Procedural Guidance for Joint Scientific Consultations (JSC) on Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) Joint Clinical Assessment report on tarlatamab (Imdylltra ) Joint Clinical Assessment report on lurbinectedin(Zepzelca) JCA report on Ojemda (tovorafenib) Guiding Principles on Data Transparency HTACG HTA FAQ publication of JCA report Questions and Answers on general methodological and procedural issues for joint clinical assessments

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Published by EU HTA Regulation Implementation. HealthSignal links to the original document; the summary above is extracted from the source text.