Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne bas\u00e9e \u00e0 Amsterdam (Pays-Bas), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP). Il concerne la ligne directrice ICH M13B sur la bio\u00e9quivalence des formes orales solides \u00e0 lib\u00e9ration imm\u00e9diate, sp\u00e9cifiquement pour l\u2019octroi de d\u00e9rogations (\u00ab biowaiver \u00bb) pour les dosages suppl\u00e9mentaires d\u2019un m\u00eame m\u00e9dicament.<\/p>\n
La ligne directrice M13B a suivi la proc\u00e9dure ICH (International Council for Harmonisation) : transmission au CHMP le 13 mars 2025, adoption par le CHMP le 27 mars 2025, publication pour consultation publique le 9 avril 2025, avec une date limite de commentaires fix\u00e9e au 9 juillet 2025. Elle a ensuite \u00e9t\u00e9 ent\u00e9rin\u00e9e par les membres de l\u2019Assembl\u00e9e de l\u2019ICH sous l\u2019\u00e9tape 2 (13 mars 2025), puis par les membres r\u00e9glementaires de l\u2019ICH \u00e0 l\u2019\u00e9tape 4 le 4 ao\u00fbt 2026. L\u2019adoption finale par le CHMP est intervenue le 17 septembre 2026, pour une entr\u00e9e en vigueur pr\u00e9vue le 17 mars 2027.<\/p>\n
Le texte vise \u00e0 pr\u00e9ciser les crit\u00e8res permettant de ne pas exiger d\u2019\u00e9tude de bio\u00e9quivalence compl\u00e8te pour certaines forces suppl\u00e9mentaires d\u2019un m\u00e9dicament \u00e0 lib\u00e9ration imm\u00e9diate, lorsque des conditions techniques sont remplies. Parmi les \u00e9l\u00e9ments structurants figurent la s\u00e9lection des dosages utilis\u00e9s pour les lots de r\u00e9f\u00e9rence en vue de la bio\u00e9quivalence, l\u2019exigence d\u2019une composition qualitative et quantitative coh\u00e9rente entre les diff\u00e9rentes forces, ainsi que la prise en compte des aspects de fabrication (processus de fabrication, \u00e9quivalence de formulation). La ligne directrice d\u00e9taille aussi les conditions d\u2019essais de dissolution comparative devant d\u00e9montrer que les diff\u00e9rentes forces pr\u00e9sentent un comportement de dissolution similaire.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont l\u2019Agence europ\u00e9enne des m\u00e9dicaments et son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain, ainsi que l\u2019ICH et ses membres, en tant qu\u2019instance d\u2019harmonisation internationale des exigences r\u00e9glementaires. Le document s\u2019inscrit dans la normalisation des crit\u00e8res de bio\u00e9quivalence au niveau international pour les formes orales solides \u00e0 lib\u00e9ration imm\u00e9diate.<\/p>\n
Sur le plan des politiques publiques de sant\u00e9, ce type de ligne directrice encadre les conditions de mise sur le march\u00e9 de dosages suppl\u00e9mentaires de m\u00e9dicaments, avec des implications potentielles en termes d\u2019acc\u00e8s \u00e0 des g\u00e9n\u00e9riques et de simplification des exigences d\u2019essais cliniques quand les crit\u00e8res de \u00ab biowaiver \u00bb sont remplis. Le texte ne fournit pas de donn\u00e9es chiffr\u00e9es ni de cas concrets, mais fixe un cadre proc\u00e9dural et m\u00e9thodologique qui devra \u00eatre pris en compte par les autorit\u00e9s r\u00e9glementaires et les industriels \u00e0 partir de mars 2027. (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 (Pays-Bas), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP). Il concerne la ligne […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"closed","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-18078","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\/18078","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=18078"}],"version-history":[{"count":1,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18078\/revisions"}],"predecessor-version":[{"id":18424,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18078\/revisions\/18424"}],"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=18078"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18078"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}