EU Health Technology Assessment
Material regulatory developments from European Commission SANTE are tracked daily by Cresthaven Analytics. Over the last 90 days, 14 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
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European Commission publishes AI use principles for Joint Clinical Assessment dossier preparation under EU HTA Regulation
The European Commission's Health directorate published general principles on July 16, 2026 governing the use of artificial intelligence in preparing Joint Clinical Assessment dossiers. The guidance sets baseline expectat…
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European Commission updates submission request template for medical devices under EU MDR
The European Commission's health directorate published an updated submission request template for medical devices on July 16, 2026. The update revises the standardized format that manufacturers and notified bodies use wh…
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European Commission publishes joint clinical assessment reports for two new lung cancer medicines under the EU HTA Regulation
On July 8, 2026, the European Commission published joint clinical assessment reports for two new lung cancer medicines under the EU Health Technology Assessment Regulation. These reports establish a common EU-level clini…
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European Commission updates the active list of joint clinical assessments under the EU HTA Regulation
The European Commission published an updated list of joint clinical assessments on July 8, 2026, under the EU Health Technology Assessment Regulation. The update reflects the current pipeline of products subject to manda…
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European Commission publishes delegated acts establishing regulatory pathways for well-established medical device technologies under the EU MDR
The European Commission published delegated acts on June 29, 2026 defining the regulatory treatment of well-established technologies under the EU Medical Devices Regulation. The acts create differentiated conformity asse…
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European Commission COMBINE programme advances to phase 2 of its pilot coordinated assessment procedure for combined clinical studies
The European Commission's COMBINE programme launched phase 2 of its pilot coordinated assessment procedure for combined studies on June 26, 2026. This marks a concrete step forward in the EU's effort to coordinate multi-…
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European Commission publishes joint clinical assessment report on tovorafenib for pediatric low-grade glioma
The European Commission's Health directorate published the joint clinical assessment report for tovorafenib (Ojemda) on June 18, 2026. This report completes a Health Technology Assessment under the EU HTA Regulation, est…
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European Commission publishes joint clinical assessment report on tovorafenib (Ojemda) under the HTA Regulation
The European Commission's Health directorate published the joint clinical assessment (JCA) report for tovorafenib (Ojemda) on June 9, 2026, under Regulation (EU) 2021/2282 on health technology assessment. The report esta…
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European Commission updates the active list of joint clinical assessments under EU HTA Regulation 2021/2282
The European Commission's Health Directorate-General updated its published list of joint clinical assessments (JCAs) on June 9, 2026 under EU HTA Regulation 2021/2282. The update reflects the current assessment scope and…
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European Commission opens new application window for HTA Joint Scientific Consultations under Regulation (EU) 2021/2282
The European Commission's DG SANTE has published a new application opportunity for Joint Scientific Consultations (JSCs) under Regulation (EU) 2021/2282 on Health Technology Assessment, effective from June 1, 2026. JSCs …
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European Commission updates Q&A guidance on joint clinical assessment methodology and procedure under EU HTA Regulation
The European Commission's Health Directorate-General published an updated Questions and Answers document on May 18, 2026 addressing methodological and procedural issues for joint clinical assessments under Regulation (EU…
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EU HTA Coordination Group adopts guiding principles on data transparency under Regulation (EU) 2021/2282
The Member State Coordination Group on Health Technology Assessment published guiding principles on data transparency on May 18, 2026, under Regulation (EU) 2021/2282. The principles govern data access and disclosure sta…
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European Commission publishes FAQ guidance on Joint Clinical Assessment report publication under EU HTA Regulation
The European Commission's Health Directorate published FAQ guidance on May 18, 2026 addressing the publication process for Joint Clinical Assessment reports under Regulation (EU) 2021/2282. The FAQ clarifies procedural a…
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European Commission HTACG flash report documents Member State coordination progress under EU HTA Regulation 2021/2282
The European Commission published a flash report on May 4, 2026 summarizing the Member State Coordination Group on HTA (HTACG) meeting of April 30, 2026. The report documents procedural and substantive coordination activ…
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