{"id":278,"date":"2026-07-29T14:54:26","date_gmt":"2026-07-29T12:54:26","guid":{"rendered":"https:\/\/www.pqra.gr\/advanced-therapy-medicinal-products-navigating-the-eu-regulatory-pathway\/"},"modified":"2026-07-29T14:54:43","modified_gmt":"2026-07-29T12:54:43","slug":"advanced-therapy-medicinal-products-navigating-the-eu-regulatory-pathway","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/advanced-therapy-medicinal-products-navigating-the-eu-regulatory-pathway\/","title":{"rendered":"Advanced Therapy Medicinal Products: Navigating the EU Regulatory Pathway"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Advanced therapy medicinal products (ATMPs) &mdash; gene therapies, somatic-cell therapies and tissue-engineered products &mdash; are among the most complex products to bring to the European market. Governed by Regulation (EC) No 1394\/2007, they follow a centralised route with a dedicated committee, specialised requirements and a narrow national exemption that is often misunderstood.<\/strong><\/p>\n\n<h2>What is an ATMP?<\/h2>\n<p>Regulation (EC) No 1394\/2007 defines three categories of ATMP: gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products. A fourth type, combined ATMPs, incorporates one or more medical devices. Because the boundaries between these categories &mdash; and with other product types &mdash; can be blurred, the classification of a product is itself a formal regulatory step.<\/p>\n\n<h2>The Committee for Advanced Therapies<\/h2>\n<p>The Regulation established the Committee for Advanced Therapies (CAT) at the EMA. The CAT is the centre of expertise for ATMPs and:<\/p>\n<ul>\n<li>issues scientific recommendations on whether a product qualifies as an ATMP (ATMP classification);<\/li>\n<li>prepares a draft opinion on the quality, safety and efficacy of each ATMP for the CHMP;<\/li>\n<li>advises on borderline and combined products.<\/li>\n<\/ul>\n<p>Because ATMPs must be authorised through the centralised procedure, a single marketing authorisation valid across the EU is the only route to market &mdash; there is no national or mutual-recognition alternative.<\/p>\n\n<h2>The hospital exemption<\/h2>\n<p>Article 28 of the Regulation created the so-called hospital exemption. It allows an ATMP to be prepared and used for an individual patient, on a non-routine basis, under the responsibility of a physician, within a single member state and without a full marketing authorisation. The exemption is implemented nationally, so requirements differ considerably between member states, and it is not a substitute for a development programme aimed at EU-wide authorisation. Sponsors relying on it need to understand exactly how their target market applies it.<\/p>\n\n<h2>Practical development considerations<\/h2>\n<ul>\n<li>Classification and early scientific advice should be sought before the pivotal programme is designed.<\/li>\n<li>ATMPs benefit from specific regulatory support, including certification of quality and non-clinical data for SMEs and access to the PRIME scheme for eligible products.<\/li>\n<li>Manufacturing and comparability are frequently the critical path; GMP for ATMPs has its own dedicated guidelines.<\/li>\n<li>Long-term follow-up and robust risk-management planning are expected given the durable nature of many of these therapies.<\/li>\n<\/ul>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA guides developers of advanced therapies through the EU framework &mdash; from ATMP classification and scientific advice, through centralised marketing-authorisation strategy, to the quality, pharmacovigilance and risk-management requirements these products demand. We help you judge when the hospital exemption is relevant and when a full authorisation is the only viable route.<\/p>\n<p><a href=\"\/el\/contact\/\">Contact PQRA<\/a> to discuss your advanced therapy programme.<\/p>","protected":false},"excerpt":{"rendered":"<p>Advanced therapy medicinal products (ATMPs) &mdash; gene therapies, somatic-cell therapies and tissue-engineered products &mdash; are among the most complex products to bring to the European market. Governed by Regulation (EC) No 1394\/2007, they follow a centralised route with a dedicated committee, specialised requirements and a narrow national exemption that is often misunderstood. What is an [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":279,"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-278","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>Advanced Therapy Medicinal Products: Navigating the EU Regulatory Pathway - 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\/advanced-therapy-medicinal-products-navigating-the-eu-regulatory-pathway\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Advanced Therapy Medicinal Products: Navigating the EU Regulatory Pathway - PQRA\" \/>\n<meta property=\"og:description\" content=\"Advanced therapy medicinal products (ATMPs) &mdash; gene therapies, somatic-cell therapies and tissue-engineered products &mdash; are among the most complex products to bring to the European market. 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