{"id":201,"date":"2026-07-07T12:43:29","date_gmt":"2026-07-07T10:43:29","guid":{"rendered":"https:\/\/www.pqra.gr\/preparing-for-the-eu-hta-regulation-a-practical-roadmap\/"},"modified":"2026-07-07T12:46:59","modified_gmt":"2026-07-07T10:46:59","slug":"preparing-for-the-eu-hta-regulation-a-practical-roadmap","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/preparing-for-the-eu-hta-regulation-a-practical-roadmap\/","title":{"rendered":"Preparing for the EU HTA Regulation: A Practical Roadmap"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>The EU HTA Regulation is now live, and the Joint Clinical Assessment is reshaping how evidence is judged across Europe. The companies that prepare early &mdash; not at launch &mdash; will move from approval to patient access fastest.<\/strong><\/p>\n<p>The Joint Clinical Assessment (JCA) delivers one EU-level evaluation of a medicine&#8217;s relative clinical effectiveness and safety. But it does not set price or reimbursement &mdash; each country, including Greece, still runs its own process. Success means preparing for both the joint and the national stages at once.<\/p>\n<h2>A practical roadmap<\/h2>\n<ul>\n<li><strong>Start early with scientific advice.<\/strong> Use Joint Scientific Consultations to align your evidence plan with HTA expectations before pivotal trials are locked.<\/li>\n<li><strong>Map every market&#8217;s PICO.<\/strong> Because Member States define their own populations and comparators, anticipate the full set of PICOs and generate comparative evidence to match &mdash; including indirect comparisons where head-to-head data are missing.<\/li>\n<li><strong>Align EMA and HTA evidence needs.<\/strong> Regulatory approval and clinical assessment run on parallel clocks; build one evidence strategy that satisfies both.<\/li>\n<li><strong>Plan the national dossier in parallel.<\/strong> Translate the JCA outcome into a country-ready submission &mdash; for Greece, an EOPYY\/HTA Committee dossier with the local economic analysis and value story.<\/li>\n<li><strong>Prepare for the phased scope.<\/strong> Oncology and ATMPs are already in scope; orphan medicines follow in 2028 and all centrally authorised products in 2030. Know when your portfolio is affected.<\/li>\n<\/ul>\n<h2>Why it matters<\/h2>\n<p>The JCA harmonises the clinical step but adds a heavier, earlier evidence burden. Companies that treat it as a launch-time formality risk deficiencies and delay; those that plan the joint and national pathways together protect their timelines.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA guides companies through the full EU HTA journey &mdash; from evidence planning and JCA readiness to the Greek national reimbursement submission &mdash; so the path from approval to access is as short and predictable as possible.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Get EU HTA-ready with PQRA &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>The EU HTA Regulation is now live, and the Joint Clinical Assessment is reshaping how evidence is judged across Europe. The companies that prepare early &mdash; not at launch &mdash; will move from approval to patient access fastest. The Joint Clinical Assessment (JCA) delivers one EU-level evaluation of a medicine&#8217;s relative clinical effectiveness and safety. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":214,"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-201","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>Preparing for the EU HTA Regulation: A Practical Roadmap - 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\/preparing-for-the-eu-hta-regulation-a-practical-roadmap\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Preparing for the EU HTA Regulation: A Practical Roadmap - PQRA\" \/>\n<meta property=\"og:description\" content=\"The EU HTA Regulation is now live, and the Joint Clinical Assessment is reshaping how evidence is judged across Europe. The companies that prepare early &mdash; not at launch &mdash; will move from approval to patient access fastest. The Joint Clinical Assessment (JCA) delivers one EU-level evaluation of a medicine&#8217;s relative clinical effectiveness and safety. 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