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EU HTA Regulation Implementation · EU-wide · 16 Jul 2026 · Guidance

EU HTA Regulation: Key documents for joint clinical assessment and scientific consultation procedures

Joint clinical assessment report oncamizestrant (Etcamah) Procedural Guidance for Joint Scientific Consultations (JSC) on Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) Procedural Guidance for Joint Scientific Consultations (JSC) on Medicinal Products (MP) Joint Clinical assessment report on onasemnogene abeparvovec (Itvisma) General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier 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