L\u2019initiative pilote \u00ab Accelerating Clinical Trials in the EU \u00bb (ACT EU), qui fournit un appui aux promoteurs pour la pr\u00e9paration de leurs demandes d\u2019essais cliniques, deviendra une initiative permanente \u00e0 partir de janvier 2027. Cette \u00e9volution vise \u00e0 am\u00e9liorer la qualit\u00e9 des dossiers soumis et l\u2019efficacit\u00e9 des proc\u00e9dures d\u2019\u00e9valuation des essais cliniques dans l\u2019Union europ\u00e9enne, en renfor\u00e7ant la coop\u00e9ration au sein du r\u00e9seau europ\u00e9en des autorit\u00e9s de r\u00e9gulation des m\u00e9dicaments.<\/p>\n
La proc\u00e9dure de conseil est coordonn\u00e9e par les Heads of Medicines Agencies (HMA) via le Clinical Trials Coordination Group (CTCG). Elle offre aux promoteurs un soutien technique et r\u00e9glementaire en amont du d\u00e9p\u00f4t de leur demande d\u2019essai clinique dans le Clinical Trials Information System (CTIS). Depuis son lancement en 2024, le pilote permet aux promoteurs de b\u00e9n\u00e9ficier de retours consolid\u00e9s des \u00c9tats membres concern\u00e9s sur des points cl\u00e9s avant soumission, ce qui contribue \u00e0 am\u00e9liorer la qualit\u00e9 des dossiers. Avant ce dispositif, l\u2019appui technique et r\u00e9glementaire n\u2019\u00e9tait disponible qu\u2019au niveau national aupr\u00e8s de l\u2019\u00c9tat membre charg\u00e9 de l\u2019\u00e9valuation.<\/p>\n
Le passage \u00e0 un dispositif permanent garantit la poursuite de cet accompagnement pour les promoteurs sollicitant un avis avant d\u00e9p\u00f4t via le CTIS. ACT EU continuera \u00e0 g\u00e9rer les demandes d\u00e9j\u00e0 introduites dans le cadre du pilote jusqu\u2019\u00e0 fin 2026. Un rapport final pr\u00e9sentant les enseignements tir\u00e9s d\u2019environ 30 demandes trait\u00e9es dans le cadre du pilote sera publi\u00e9 avant fin 2026. Des documents de r\u00e9f\u00e9rence actualis\u00e9s et de nouveaux mod\u00e8les destin\u00e9s aux promoteurs seront mis en ligne sur le site du CTCG en janvier 2027.<\/p>\n
Cette p\u00e9rennisation s\u2019inscrit dans les objectifs du European Biotech Act, en facilitant la navigation des promoteurs au sein du cadre r\u00e9glementaire europ\u00e9en des essais cliniques. Les principaux acteurs mentionn\u00e9s sont les autorit\u00e9s nationales des m\u00e9dicaments regroup\u00e9es au sein des HMA, le CTCG en charge de la coordination technique, et l\u2019EMA pour les contacts m\u00e9dias. L\u2019ensemble du dispositif concerne les \u00c9tats membres de l\u2019UE utilisant le CTIS pour l\u2019instruction des demandes d\u2019essais cliniques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019initiative pilote \u00ab Accelerating Clinical Trials in the EU \u00bb (ACT EU), qui fournit un appui aux promoteurs pour la pr\u00e9paration de leurs demandes d\u2019essais cliniques, deviendra une initiative permanente […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[31,2],"tags":[257,227,226],"class_list":["post-20294","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politiques-europeennes-sante-social-travail","category-sante-publique-et-systeme-de-soins","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20294","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20294"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20294\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20294"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20294"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}