L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence d\u00e9centralis\u00e9e de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam (Pays-Bas), a publi\u00e9 en juin 2026 une version r\u00e9vis\u00e9e (EMA\/137055\/2026 Rev. 2) d\u2019une ligne directrice sur l\u2019investigation clinique des m\u00e9dicaments destin\u00e9s au traitement de la migraine et de la c\u00e9phal\u00e9e en grappes. Ce document, de nature r\u00e9glementaire et scientifique, remplace la pr\u00e9c\u00e9dente ligne directrice CPMP\/EWP\/788\/01 Rev. 1.<\/p>\n
Le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019EMA a adopt\u00e9 le 15 juin 2026 la version \u00e0 diffuser pour consultation publique. La consultation est programm\u00e9e du 10 septembre 2026 au 31 janvier 2027. Les commentaires doivent \u00eatre transmis via un formulaire EUSurvey, avec un appui technique mis \u00e0 disposition par l\u2019assistance EUSurvey.<\/p>\n
La ligne directrice pr\u00e9cise le cadre attendu pour les essais cliniques des m\u00e9dicaments destin\u00e9s \u00e0 la prise en charge de la migraine et de la c\u00e9phal\u00e9e en grappes, en particulier pour le traitement aigu des crises et le traitement prophylactique. Elle comporte notamment des sections sur le champ d\u2019application, la base juridique et les lignes directrices associ\u00e9es, ainsi que des \u00e9l\u00e9ments g\u00e9n\u00e9raux sur la pharmacologie et les \u00e9tudes exploratoires (pharmacocin\u00e9tique, formulations, pharmacodynamie, \u00e9tudes pr\u00e9coces d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9). Elle encadre \u00e9galement la m\u00e9thodologie des \u00e9tudes pivots pour les traitements de la migraine, en d\u00e9taillant notamment la population d\u2019\u00e9tude, la conception des essais, le choix des comparateurs et les crit\u00e8res de jugement (dont la notion de \u00ab jour de migraine \u00bb et la prise en compte de l\u2019aura).<\/p>\n
Les principaux acteurs mentionn\u00e9s sont l\u2019EMA, son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) et le groupe de travail sur le syst\u00e8me nerveux central (Central Nervous System Working Party), qui a approuv\u00e9 le projet de texte en janvier 2026. Le document comporte des mots-cl\u00e9s op\u00e9rationnels pour le champ th\u00e9rapeutique (migraine, aura, journ\u00e9e de migraine, c\u00e9phal\u00e9e en grappes, traitement aigu des crises, traitement prophylactique), ce qui indique l\u2019orientation de la ligne directrice vers la standardisation des crit\u00e8res et des m\u00e9thodes d\u2019\u00e9valuation des m\u00e9dicaments dans ces indications.<\/p>\n
Pour le suivi des politiques publiques, ce texte s\u2019inscrit dans l\u2019\u00e9volution du cadre europ\u00e9en d\u2019\u00e9valuation des m\u00e9dicaments neurologiques. Il peut avoir des implications potentielles pour la conception des essais cliniques, les exigences r\u00e9glementaires et, \u00e0 terme, l\u2019acc\u00e8s au march\u00e9 des traitements de la migraine et de la c\u00e9phal\u00e9e en grappes dans les \u00c9tats membres, y compris la France, une fois la version finale adopt\u00e9e \u00e0 l\u2019issue de la consultation. Le document signale enfin que la reproduction est autoris\u00e9e sous r\u00e9serve de mentionner la source, ce qui facilite sa diffusion et son utilisation par les administrations nationales. (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 d\u00e9centralis\u00e9e de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam (Pays-Bas), a publi\u00e9 en juin 2026 une version r\u00e9vis\u00e9e (EMA\/137055\/2026 Rev. 2) d\u2019une ligne directrice sur l\u2019investigation […]<\/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-17735","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\/17735","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=17735"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17735\/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=17735"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17735"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17735"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}