Le document \u00e9mane du Comit\u00e9 des m\u00e9dicaments \u00e0 base de plantes (HMPC) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), bas\u00e9e \u00e0 Amsterdam (Pays-Bas). Il s\u2019agit d\u2019un projet de \u00ab reflection paper \u00bb consacr\u00e9 \u00e0 l\u2019investigation des interactions m\u00e9dicamenteuses impliquant les m\u00e9dicaments \u00e0 base de plantes (herbal medicinal products \u2013 HMPs), y compris les m\u00e9dicaments traditionnels \u00e0 base de plantes (traditional herbal medicinal products \u2013 THMPs). Ce document de r\u00e9flexion a \u00e9t\u00e9 adopt\u00e9 par le HMPC le 24 septembre 2026 en vue d\u2019une mise en consultation publique.<\/p>\n
La consultation publique est pr\u00e9vue du 15 octobre 2026 au 15 janvier 2027. Les commentaires doivent \u00eatre transmis au secr\u00e9tariat du HMPC via une adresse \u00e9lectronique d\u00e9di\u00e9e, en utilisant un mod\u00e8le de contribution sp\u00e9cifique. La reproduction du document est autoris\u00e9e sous r\u00e9serve de mentionner la source.<\/p>\n
Ce texte intervient dans le contexte de l\u2019entr\u00e9e en vigueur, en novembre 2024, de la ligne directrice ICH M12 relative aux \u00e9tudes d\u2019interactions m\u00e9dicamenteuses. Cette ligne directrice ICH M12, de port\u00e9e internationale, est centr\u00e9e sur les interactions pharmacocin\u00e9tiques et vise principalement le d\u00e9veloppement des petites mol\u00e9cules chimiques. Elle remplace formellement l\u2019ancienne ligne directrice de l\u2019EMA sur l\u2019investigation des interactions m\u00e9dicamenteuses, mais ne traite pas certains sujets avec le m\u00eame niveau de d\u00e9tail, notamment les recommandations sp\u00e9cifiques pour l\u2019\u00e9valuation du potentiel d\u2019interactions des HMPs et THMPs.<\/p>\n
Le document du HMPC vise donc \u00e0 compl\u00e9ter ce cadre en se focalisant sur les m\u00e9dicaments \u00e0 base de plantes, en s\u2019inscrivant dans la strat\u00e9gie de mise en \u0153uvre d\u2019ICH M12. Il pr\u00e9cise que les principes g\u00e9n\u00e9raux pharmacocin\u00e9tiques d\u00e9crits dans ICH M12 sont consid\u00e9r\u00e9s comme applicables \u00e9galement aux HMPs et THMPs, tout en reconnaissant qu\u2019un traitement plus sp\u00e9cifique de ces produits reste n\u00e9cessaire. Les mots-cl\u00e9s associ\u00e9s au document incluent les monographies europ\u00e9ennes de plantes, les substances et pr\u00e9parations v\u00e9g\u00e9tales, les interactions m\u00e9dicamenteuses (drug-drug interactions, DDIs) et la mise en \u0153uvre d\u2019ICH M12, ce qui souligne l\u2019articulation entre r\u00e9glementation europ\u00e9enne sur les produits \u00e0 base de plantes et standards internationaux en mati\u00e8re d\u2019interactions m\u00e9dicamenteuses. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document \u00e9mane du Comit\u00e9 des m\u00e9dicaments \u00e0 base de plantes (HMPC) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), bas\u00e9e \u00e0 Amsterdam (Pays-Bas). Il s\u2019agit d\u2019un projet de \u00ab reflection paper […]<\/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-21144","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\/21144","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=21144"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21144\/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=21144"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21144"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}