Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam, et pr\u00e9sente un projet de ligne directrice (\u00ab guideline \u00bb) du Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) sur l\u2019investigation des interactions au niveau du tractus gastro-intestinal. Ce texte, r\u00e9f\u00e9renc\u00e9 EMA\/136069\/2026, porte sur l\u2019\u00e9valuation de la mani\u00e8re dont l\u2019absorption des m\u00e9dicaments peut \u00eatre influenc\u00e9e par diff\u00e9rents facteurs gastro-intestinaux.<\/p>\n
Le projet de guideline a \u00e9t\u00e9 \u00e9labor\u00e9 par le Methodology Working Party (MWP), apr\u00e8s consultation du Quality Working Party, en mars 2026. Il a \u00e9t\u00e9 adopt\u00e9 par le CHMP pour mise en consultation publique le 15 juin 2026. La consultation publique doit d\u00e9buter le 11 septembre 2026 et s\u2019achever le 31 d\u00e9cembre 2026. Les commentaires doivent \u00eatre transmis via un formulaire EUSurvey, avec un support technique d\u00e9di\u00e9 en cas de difficult\u00e9s. La reproduction du document est autoris\u00e9e sous r\u00e9serve de mentionner la source.<\/p>\n
Le texte pr\u00e9cise son champ d\u2019application, ses bases juridiques et les lignes directrices europ\u00e9ennes connexes, puis d\u00e9taille les recommandations m\u00e9thodologiques pour l\u2019investigation des interactions dans le tractus gastro-intestinal. Les principales th\u00e9matiques abord\u00e9es concernent les effets de la prise alimentaire sur la pharmacocin\u00e9tique des m\u00e9dicaments en d\u00e9veloppement, les interactions li\u00e9es \u00e0 la modification du pH gastrique (notamment via des m\u00e9dicaments r\u00e9duisant l\u2019acidit\u00e9 gastrique), l\u2019impact de la vidange gastrique et de la motilit\u00e9 intestinale, le r\u00f4le des excipients, la formation de complexes pouvant modifier l\u2019absorption et la recirculation ent\u00e9roh\u00e9patique. Des sections sp\u00e9cifiques portent \u00e9galement sur le reporting et l\u2019interpr\u00e9tation des r\u00e9sultats ainsi que sur l\u2019\u00e9valuation et la gestion des risques associ\u00e9s \u00e0 ces interactions.<\/p>\n
Les acteurs cl\u00e9s sont le CHMP, en charge de l\u2019adoption et de la mise en consultation de la guideline, ainsi que les groupes de travail m\u00e9thodologie (MWP) et qualit\u00e9, qui ont contribu\u00e9 \u00e0 son \u00e9laboration. L\u2019EMA organise le processus de consultation via la plateforme EUSurvey. Le document vise en priorit\u00e9 les d\u00e9veloppeurs et \u00e9valuateurs de m\u00e9dicaments au sein de l\u2019Union europ\u00e9enne, avec des implications potentielles pour les proc\u00e9dures d\u2019autorisation de mise sur le march\u00e9 et la surveillance des risques li\u00e9s \u00e0 l\u2019absorption des m\u00e9dicaments, notamment en lien avec l\u2019alimentation, la formulation et les co-m\u00e9dications influen\u00e7ant le pH gastrique. Les \u00e9l\u00e9ments plus d\u00e9taill\u00e9s de contenu scientifique et r\u00e9glementaire ne sont pas enti\u00e8rement disponibles dans l\u2019extrait, mais la structure annonc\u00e9e indique une volont\u00e9 d\u2019harmoniser au niveau europ\u00e9en les approches d\u2019\u00e9valuation de ces interactions gastro-intestinales. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam, et pr\u00e9sente un projet de ligne directrice (\u00ab guideline \u00bb) du Comit\u00e9 des m\u00e9dicaments […]<\/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":[36,31],"tags":[257,227,226],"class_list":["post-17734","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-droit-social-sante-travail-et-securite-sociale","category-politiques-europeennes-sante-social-travail","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17734","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=17734"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17734\/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=17734"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17734"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}