{"id":196,"date":"2026-07-07T12:42:15","date_gmt":"2026-07-07T10:42:15","guid":{"rendered":"https:\/\/www.pqra.gr\/the-eu-joint-clinical-assessment-what-it-means-for-your-product\/"},"modified":"2026-07-07T12:44:00","modified_gmt":"2026-07-07T10:44:00","slug":"the-eu-joint-clinical-assessment-what-it-means-for-your-product","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-eu-joint-clinical-assessment-what-it-means-for-your-product\/","title":{"rendered":"The EU Joint Clinical Assessment: What It Means for Your Product"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>From January 2025, the way new medicines are clinically assessed in Europe changed. The Joint Clinical Assessment (JCA) introduces a single, EU-wide evaluation of clinical evidence &mdash; and for companies, it reshapes how evidence must be planned long before launch.<\/strong><\/p>\n<p>The EU Health Technology Assessment Regulation (Regulation (EU) 2021\/2282) began applying on 12 January 2025. At its heart is the JCA: a joint, EU-level assessment of the relative clinical effectiveness and safety of a new health technology, carried out once on behalf of all Member States rather than 27 times over.<\/p>\n<h2>Who is in scope, and when<\/h2>\n<p>The JCA is being phased in by product type:<\/p>\n<ul>\n<li><strong>From January 2025<\/strong> &mdash; new active substance <strong>oncology<\/strong> medicines and <strong>advanced therapy medicinal products (ATMPs)<\/strong>.<\/li>\n<li><strong>From January 2028<\/strong> &mdash; <strong>orphan medicinal products<\/strong>.<\/li>\n<li><strong>From January 2030<\/strong> &mdash; all remaining centrally authorised medicines.<\/li>\n<\/ul>\n<p>The first-ever JCA report &mdash; for tovorafenib (Ojemda) in paediatric low-grade glioma &mdash; was adopted by the HTA Coordination Group and published in June 2026, with further assessments already in the pipeline.<\/p>\n<h2>How it works: the PICO challenge<\/h2>\n<p>Each JCA is led by an assessor and co-assessor from two Member States, with input from all 27. Member States submit their national research questions, consolidated into <strong>PICO<\/strong> frameworks (Population, Intervention, Comparator, Outcome). Because national comparators and patient populations differ, a single product can generate <strong>multiple PICOs<\/strong> &mdash; meaning companies must prepare a far broader evidence package than any one national assessment required. Joint Scientific Consultations let developers seek advice on evidence needs before pivotal trials begin.<\/p>\n<h2>What JCA does &mdash; and does not &mdash; decide<\/h2>\n<p>The JCA produces a <strong>non-binding scientific report<\/strong> on relative clinical effectiveness and safety. It does <strong>\u03b4\u03b5\u03bd<\/strong> assess cost-effectiveness, and it does <strong>\u03b4\u03b5\u03bd<\/strong> set price or reimbursement. Those decisions remain fully national. Member States must give the JCA report &#8220;due consideration,&#8221; but each country &mdash; including Greece through EOF and the HTA Committee &mdash; still runs its own pricing and reimbursement process.<\/p>\n<h2>What it means for you<\/h2>\n<p>JCA runs on a tight clock in parallel with the EMA marketing-authorisation review, and the multi-PICO burden means evidence generation must anticipate every market&#8217;s comparators up front. It harmonises the clinical step but does not replace national negotiations &mdash; so early, EU-wide evidence planning is now essential.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Talk to PQRA about your JCA and market-access strategy &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>From January 2025, the way new medicines are clinically assessed in Europe changed. The Joint Clinical Assessment (JCA) introduces a single, EU-wide evaluation of clinical evidence &mdash; and for companies, it reshapes how evidence must be planned long before launch. The EU Health Technology Assessment Regulation (Regulation (EU) 2021\/2282) began applying on 12 January 2025. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":202,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_kadence_starter_templates_imported_post":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-196","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The EU Joint Clinical Assessment: What It Means for Your Product - PQRA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/the-eu-joint-clinical-assessment-what-it-means-for-your-product\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The EU Joint Clinical Assessment: What It Means for Your Product - PQRA\" \/>\n<meta property=\"og:description\" content=\"From January 2025, the way new medicines are clinically assessed in Europe changed. 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