{"id":10714,"date":"2026-09-17T08:51:44","date_gmt":"2026-09-17T06:51:44","guid":{"rendered":"https:\/\/www.essecieffe.it\/aifa-updates-the-e-dossier-platform-to-implement-regulation-eu-2021-2282\/"},"modified":"2026-10-13T14:43:14","modified_gmt":"2026-10-13T12:43:14","slug":"aifa-updates-the-e-dossier-platform-to-implement-regulation-eu-2021-2282","status":"publish","type":"post","link":"https:\/\/www.essecieffe.it\/en\/aifa-updates-the-e-dossier-platform-to-implement-regulation-eu-2021-2282\/","title":{"rendered":"AIFA Updates the e-Dossier Platform to Implement Regulation (EU) 2021\/2282"},"content":{"rendered":"<p>As of 14 September 2026, an <strong>update to the eDossier platform is available<\/strong>, aimed at incorporating the provisions of Regulation (EU) 2021\/2282 (HTA Regulation).<\/p>\n<p>\ud83d\udccc Section A.3 \u2013 Regulatory Status of the Product<br \/>\nFor TN-1 negotiation types,<strong> the Company must indicate whether the product is subject to a Joint Clinical Assessment (JCA)<\/strong>. If so, the following information must be provided:<br \/>\nthe JCA identification number;<br \/>\nthe type of product;<br \/>\nthe JCA status: ongoing \/ discontinued \/ adopted by the Coordination Group \/ published by the European Commission.<\/p>\n<p>\ud83d\udcc4 Section C.3 \u2013 Description of the Evidence Supporting the Application in Terms of Efficacy and Safety<br \/>\nIt must be specified whether <strong>additional evidence<\/strong> is being submitted beyond that requested by the European Commission or already assessed by the HTA Coordination Group (HTACG) and its JCA Subgroup. The characteristics of such evidence and the reasons why it should be considered at national level must also be specified.<\/p>\n<p>\ud83c\udfaf For medicinal products subject to JCA<br \/>\n<strong>Completion of Sections C.4, C.5 and C.6 is not mandatory <\/strong>when the JCA status is \u201c<em>Adopted by the Coordination Group<\/em>\u201d or \u201c<em>Published by the EC<\/em>\u201d.<br \/>\nCompletion of these sections remains mandatory when the JCA status is \u201c<em>Ongoing \u2013 prior to adoption by the Coordination Group<\/em>\u201d or \u201c<em>Discontinued<\/em>\u201d.<\/p>\n<p>For products subject to a JCA Report, should the Company complete Section C, the information provided will be promptly shared with the Coordination Group, pursuant to Article 13(1)(e) of the HTA Regulation. <\/p>\n<p>Source: <a href=\"https:\/\/www.aifa.gov.it\/-\/aggiornamento-della-piattaforma-edossier-in-attuazione-del-regolamento-ue-2021\/2282\">https:\/\/www.aifa.gov.it\/-\/aggiornamento-della-piattaforma-edossier-in-attuazione-del-regolamento-ue-2021\/2282<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As of 14 September 2026, an update to the eDossier platform is available, aimed at incorporating the provisions of Regulation (EU) 2021\/2282 (HTA Regulation). \ud83d\udccc Section A.3 \u2013 Regulatory Status of the Product For TN-1 negotiation types, the Company must indicate whether the product is subject to a Joint Clinical Assessment (JCA). If so, the&#8230;<\/p>\n","protected":false},"author":6,"featured_media":10713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[28],"tags":[33,66],"class_list":["post-10714","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-aifa","tag-hta"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AIFA Updates the e-Dossier Platform to Implement Regulation (EU) 2021\/2282 - Studio Consulenza Farmacologica<\/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.essecieffe.it\/en\/aifa-updates-the-e-dossier-platform-to-implement-regulation-eu-2021-2282\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AIFA Updates the e-Dossier Platform to Implement Regulation (EU) 2021\/2282 - Studio Consulenza Farmacologica\" \/>\n<meta property=\"og:description\" content=\"As of 14 September 2026, an update to the eDossier platform is available, aimed at incorporating the provisions of Regulation (EU) 2021\/2282 (HTA Regulation). \ud83d\udccc Section A.3 \u2013 Regulatory Status of the Product For TN-1 negotiation types, the Company must indicate whether the product is subject to a Joint Clinical Assessment (JCA). 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