L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a lanc\u00e9 un nouveau dispositif pilote de soumission volontaire de donn\u00e9es (\u00ab Voluntary Data Submission \u2013 VDS \u00bb) portant sur les \u00ab New Approach Methodologies \u00bb (NAMs), dans le cadre du d\u00e9veloppement non clinique des m\u00e9dicaments. L\u2019objectif est de faciliter le partage avec les autorit\u00e9s de donn\u00e9es issues de m\u00e9thodes alternatives innovantes aux \u00e9tudes animales traditionnelles, et de renforcer leur acceptation r\u00e9glementaire au niveau europ\u00e9en.<\/p>\n
Les NAMs mentionn\u00e9es comprennent notamment des syst\u00e8mes in vitro complexes (tels que les organo\u00efdes et les syst\u00e8mes microphysiologiques), des mod\u00e8les de mod\u00e9lisation informatique, ainsi que des approches combinant plusieurs m\u00e9thodologies. Selon l\u2019EMA, ces m\u00e9thodes ont le potentiel de fournir des informations comparables ou sup\u00e9rieures \u00e0 celles des approches actuelles, tout en contribuant \u00e0 la r\u00e9duction ou au remplacement des essais sur l\u2019animal. Cette initiative s\u2019inscrit dans l\u2019engagement de longue date de l\u2019Agence en faveur des principes des 3R (remplacer, r\u00e9duire, raffiner l\u2019utilisation des animaux).<\/p>\n
Le pilote VDS met en place un cadre structur\u00e9, non contraignant, permettant aux entreprises pharmaceutiques, d\u00e9veloppeurs de m\u00e9thodes, organismes de recherche sous contrat, laboratoires acad\u00e9miques et autres acteurs de soumettre volontairement des donn\u00e9es issues de NAMs en dehors de toute proc\u00e9dure de demande d\u2019autorisation de mise sur le march\u00e9. Les participants recevront un retour scientifique individualis\u00e9, non contraignant et sans port\u00e9e d\u00e9cisionnelle de la part d\u2019un groupe op\u00e9rationnel d\u2019experts non cliniques issus du r\u00e9seau r\u00e9glementaire europ\u00e9en du m\u00e9dicament.<\/p>\n
Les finalit\u00e9s principales du dispositif sont d\u2019accro\u00eetre le dialogue scientifique entre r\u00e9gulateurs et utilisateurs de NAMs, de d\u00e9velopper l\u2019exp\u00e9rience r\u00e9glementaire sur ces m\u00e9thodes, de favoriser une approche d\u2019\u00e9valuation harmonis\u00e9e \u00e0 l\u2019\u00e9chelle europ\u00e9enne et de contribuer \u00e0 la mise en place d\u2019un cadre durable pour l\u2019int\u00e9gration de ces outils dans la r\u00e9glementation du m\u00e9dicament. L\u2019EMA souligne que, bien que les NAMs soient de plus en plus utilis\u00e9es en recherche et en d\u00e9veloppement pr\u00e9coce, les donn\u00e9es correspondantes sont rarement communiqu\u00e9es aux autorit\u00e9s, ce qui limite la consolidation de la confiance dans leur usage r\u00e9glementaire.<\/p>\n
Les organisations int\u00e9ress\u00e9es sont invit\u00e9es \u00e0 d\u00e9poser un formulaire de manifestation d\u2019int\u00e9r\u00eat. Apr\u00e8s une premi\u00e8re phase de validation, certaines seront convi\u00e9es \u00e0 soumettre un dossier complet pour \u00e9valuation scientifique. Un document d\u2019information pr\u00e9cise le p\u00e9rim\u00e8tre du pilote, les crit\u00e8res d\u2019\u00e9ligibilit\u00e9, les exigences de soumission et le processus d\u2019\u00e9valuation. Les soumissions dans le cadre de ce pilote sont attendues jusqu\u2019au troisi\u00e8me trimestre 2027. \u00c0 l\u2019issue de l\u2019exp\u00e9rimentation, l\u2019EMA publiera un rapport de type \u00ab retour d\u2019exp\u00e9rience \u00bb (\u00ab lessons-learned report \u00bb). (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a lanc\u00e9 un nouveau dispositif pilote de soumission volontaire de donn\u00e9es (\u00ab Voluntary Data Submission \u2013 VDS \u00bb) portant sur les \u00ab New Approach Methodologies […]<\/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-17715","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\/17715","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=17715"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17715\/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=17715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}