L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), bas\u00e9e \u00e0 Amsterdam, a publi\u00e9 le 5 octobre 2026 un projet de ligne directrice (\u00ab guideline \u00bb) \u00e9labor\u00e9 par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) concernant les exigences pour d\u00e9montrer l\u2019\u00e9quivalence th\u00e9rapeutique des m\u00e9dicaments administr\u00e9s par voie nasale. Ce document, r\u00e9f\u00e9renc\u00e9 EMA\/220888\/2026, porte sp\u00e9cifiquement sur les produits nasaux et d\u00e9finit les conditions scientifiques et m\u00e9thodologiques permettant de conclure \u00e0 une \u00e9quivalence th\u00e9rapeutique entre un m\u00e9dicament de r\u00e9f\u00e9rence et un m\u00e9dicament comparable.<\/p>\n
Le projet a \u00e9t\u00e9 pr\u00e9par\u00e9 par le groupe de travail sur les maladies immunologiques et inflammatoires (Immunologic and Inflammatory Diseases Working Party, IIWP), qui a arr\u00eat\u00e9 une version de travail en juillet 2026. Le CHMP a adopt\u00e9 ce projet pour consultation publique le 5 octobre 2026. La consultation publique d\u00e9marre le 8 octobre 2026 et s\u2019ach\u00e8ve le 28 f\u00e9vrier 2027. Les commentaires doivent \u00eatre soumis via un formulaire EUSurvey, avec un appui technique assur\u00e9 par le support EUSurvey.<\/p>\n
La ligne directrice s\u2019adresse au cadre r\u00e9glementaire europ\u00e9en des m\u00e9dicaments et pr\u00e9cise, pour les produits nasaux, les \u00e9l\u00e9ments \u00e0 consid\u00e9rer en mati\u00e8re de comparaisons in vitro, d\u2019\u00e9tudes pharmacocin\u00e9tiques, pharmacodynamiques et cliniques, ainsi que de tol\u00e9rance locale. Elle couvre \u00e0 la fois les m\u00e9dicaments \u00e0 action locale et ceux \u00e0 action syst\u00e9mique administr\u00e9s par voie nasale, en distinguant notamment les exigences li\u00e9es \u00e0 l\u2019\u00e9quivalence en termes de s\u00e9curit\u00e9 syst\u00e9mique et celles li\u00e9es \u00e0 l\u2019efficacit\u00e9. Le document renvoie \u00e9galement aux bases juridiques et autres lignes directrices pertinentes dans le syst\u00e8me europ\u00e9en. Cette initiative de l\u2019EMA et du CHMP vise \u00e0 harmoniser au niveau de l\u2019Union europ\u00e9enne les crit\u00e8res d\u2019\u00e9valuation de l\u2019\u00e9quivalence th\u00e9rapeutique des produits nasaux, dans un cadre consultatif o\u00f9 les parties prenantes peuvent contribuer jusqu\u2019\u00e0 fin f\u00e9vrier 2027. (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), bas\u00e9e \u00e0 Amsterdam, a publi\u00e9 le 5 octobre 2026 un projet de ligne directrice (\u00ab guideline \u00bb) \u00e9labor\u00e9 par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage […]<\/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":[7],"tags":[257,227,226],"class_list":["post-20282","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20282","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=20282"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20282\/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=20282"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20282"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}