{"id":294,"date":"2026-07-29T15:10:26","date_gmt":"2026-07-29T13:10:26","guid":{"rendered":"https:\/\/www.pqra.gr\/joint-clinical-assessment-for-gene-therapies-in-scope-from-day-one\/"},"modified":"2026-07-29T15:10:43","modified_gmt":"2026-07-29T13:10:43","slug":"joint-clinical-assessment-for-gene-therapies-in-scope-from-day-one","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/joint-clinical-assessment-for-gene-therapies-in-scope-from-day-one\/","title":{"rendered":"\u039a\u03bf\u03b9\u03bd\u03ae \u039a\u03bb\u03b9\u03bd\u03b9\u03ba\u03ae \u0391\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03b3\u03b9\u03b1 \u0393\u03bf\u03bd\u03b9\u03b4\u03b9\u03b1\u03ba\u03ad\u03c2 \u0398\u03b5\u03c1\u03b1\u03c0\u03b5\u03af\u03b5\u03c2: \u03a3\u03c4\u03bf \u03a0\u03b5\u03b4\u03af\u03bf \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd \u03c0\u03c1\u03ce\u03c4\u03b7 \u039c\u03ad\u03c1\u03b1"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Unlike most medicines, gene therapies have been subject to the EU Joint Clinical Assessment (JCA) since it began on 12 January 2025. As advanced therapy medicinal products (ATMPs), they were placed in the very first wave &mdash; so developers face an EU-wide clinical assessment at launch, frequently on the strength of a single, small trial.<\/strong><\/p>\n\n<h2>Why gene therapies were first<\/h2>\n<p>Under Regulation (EU) 2021\/2282, the JCA prioritised new oncology active substances and ATMPs from January 2025, ahead of orphan medicines (2028) and all other products (2030). Because gene therapies are ATMPs, they fell automatically into that first cohort. Many are also orphan and\/or oncology products, which only reinforces their early entry into scope. In practice, a gene therapy cannot wait for a later phase-in date &mdash; if it is in development now, JCA readiness is a launch requirement, not a future concern.<\/p>\n\n<h2>The evidence challenge<\/h2>\n<p>Gene therapies sit awkwardly against a comparative-assessment framework designed with conventional trials in mind:<\/p>\n<ul>\n<li>Pivotal evidence is often a single-arm study with a small sample, surrogate endpoints and short follow-up &mdash; set against durable or potentially curative claims.<\/li>\n<li>PICOs are consolidated across member states, and the comparator is frequently a lifetime of chronic standard-of-care that the one-time therapy aims to replace.<\/li>\n<li>Long-term durability and safety attract particular scrutiny; some cell and gene therapies carry serious risks such as severe immune reactions.<\/li>\n<li>Indirect comparisons and external control arms are usually needed to bridge the gap to the requested comparators and outcomes.<\/li>\n<\/ul>\n\n<h2>Illustrative case study: a one-time gene therapy for an inherited disorder<\/h2>\n<p><em>The following is a hypothetical scenario for illustration only.<\/em> A developer brings a single-administration gene therapy for an inherited disorder to market. The pivotal trial is single-arm, compared with a natural-history cohort, using a biomarker and limited functional outcomes over two years of follow-up. During scoping, the consolidated assessment contains several PICOs: some countries specify chronic standard management as the comparator, others an emerging alternative therapy, and most request longer-term, patient-relevant outcomes. Having built an external comparator from a natural-history registry and pre-planned indirect comparisons, the developer could address most PICOs within the dossier window. The durability uncertainty was handled through a transparent, pre-agreed narrative and, at national level, through discussions on outcome-based managed entry agreements.<\/p>\n\n<h2>Preparing a gene therapy for JCA<\/h2>\n<ul>\n<li>Engage early through a Joint Scientific Consultation to test the evidence plan with HTA bodies and the EMA together.<\/li>\n<li>Build external comparator and natural-history data well before the pivotal read-out.<\/li>\n<li>Plan explicitly for durability uncertainty, and align it with national managed entry agreements.<\/li>\n<li>Synchronise the JCA dossier with the EMA centralised procedure, which is mandatory for ATMPs.<\/li>\n<\/ul>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA supports advanced-therapy developers through the JCA from the outset &mdash; anticipating PICOs, strengthening external-comparator and natural-history evidence, preparing indirect comparisons, and coordinating Joint Scientific Consultation, the centralised EMA submission and national reimbursement strategy in Greece and across the EU. We help ensure a first-in-class therapy is not held back by an assessment it was not prepared for.<\/p>\n<p><a href=\"\/el\/contact\/\">Contact PQRA<\/a> to prepare your gene therapy for Joint Clinical Assessment.<\/p>","protected":false},"excerpt":{"rendered":"<p>Unlike most medicines, gene therapies have been subject to the EU Joint Clinical Assessment (JCA) since it began on 12 January 2025. As advanced therapy medicinal products (ATMPs), they were placed in the very first wave &mdash; so developers face an EU-wide clinical assessment at launch, frequently on the strength of a single, small trial. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":295,"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-294","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>Joint Clinical Assessment for Gene Therapies: In Scope from Day One - 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\/joint-clinical-assessment-for-gene-therapies-in-scope-from-day-one\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Joint Clinical Assessment for Gene Therapies: In Scope from Day One - PQRA\" \/>\n<meta property=\"og:description\" content=\"Unlike most medicines, gene therapies have been subject to the EU Joint Clinical Assessment (JCA) since it began on 12 January 2025. 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