L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam (Pays-Bas), a \u00e9labor\u00e9 des \u00ab principes m\u00e9thodologiques pour l\u2019\u00e9valuation de la section 5.1 du r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP) \u00bb, portant sur la s\u00e9lection des \u00e9tudes d\u2019efficacit\u00e9 \u00e0 inclure et sur la mani\u00e8re de d\u00e9crire le design des essais et leurs r\u00e9sultats. Ce document est un guide r\u00e9glementaire et scientifique destin\u00e9 au Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP).<\/p>\n
Le texte pr\u00e9cise le calendrier d\u2019\u00e9laboration et d\u2019adoption : adoption par le CHMP pour diffusion en consultation en novembre 2023, lancement de la consultation publique le 15 d\u00e9cembre 2023, cl\u00f4ture de la consultation le 4 mars 2024, accord par le groupe de travail MWP en octobre 2025, adoption finale par le CHMP le 26 juin 2026, avec une entr\u00e9e en vigueur fix\u00e9e au 1er janvier 2027. Il s\u2019inscrit dans le cadre des lignes directrices m\u00e9thodologiques de l\u2019EMA pour l\u2019\u00e9valuation des m\u00e9dicaments au niveau europ\u00e9en.<\/p>\n
Le document couvre principalement : les crit\u00e8res de choix des \u00e9tudes d\u2019efficacit\u00e9 \u00e0 inclure dans la section 5.1 du RCP, avec une attention sp\u00e9cifique port\u00e9e aux \u00e9tudes comparatives et \u00e0 la population p\u00e9diatrique ; la mani\u00e8re de d\u00e9crire les \u00e9l\u00e9ments de design des essais (traitement, population, crit\u00e8res de jugement) et les r\u00e9sultats ; le traitement des situations particuli\u00e8res relatives aux crit\u00e8res d\u2019\u00e9valuation ; la pr\u00e9sentation des analyses de sous-groupes ; la gestion des analyses interm\u00e9diaires, des dates de coupure des donn\u00e9es et des mises \u00e0 jour ; la synth\u00e8se de l\u2019effet du traitement dans le texte, les tableaux et les figures, y compris l\u2019utilisation des intervalles de confiance et des valeurs p.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont le CHMP, en charge de l\u2019\u00e9valuation scientifique des m\u00e9dicaments \u00e0 usage humain, et le groupe de travail MWP, impliqu\u00e9 dans l\u2019accord technique sur le contenu m\u00e9thodologique. Le document s\u2019inscrit dans le corpus de lignes directrices r\u00e9glementaires de l\u2019EMA et vise \u00e0 harmoniser la mani\u00e8re dont sont rapport\u00e9s les r\u00e9sultats d\u2019efficacit\u00e9 des m\u00e9dicaments dans l\u2019Union europ\u00e9enne, avec un impact potentiel sur la lisibilit\u00e9 et la comparabilit\u00e9 des informations disponibles pour les autorit\u00e9s sanitaires et les d\u00e9cideurs publics. Le texte pr\u00e9cise que la reproduction est autoris\u00e9e sous r\u00e9serve de mentionner la source. (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), agence de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam (Pays-Bas), a \u00e9labor\u00e9 des \u00ab principes m\u00e9thodologiques pour l\u2019\u00e9valuation de la section 5.1 du r\u00e9sum\u00e9 des caract\u00e9ristiques du […]<\/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-21410","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\/21410","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=21410"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21410\/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=21410"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21410"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21410"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}