En octobre 2026, le comit\u00e9 pour l\u2019\u00e9valuation des risques en pharmacovigilance (PRAC) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a tenu sa r\u00e9union mensuelle consacr\u00e9e au suivi de la s\u00e9curit\u00e9 des m\u00e9dicaments. Aucun nouveau recours \u00e0 une proc\u00e9dure de r\u00e9examen (referral) n\u2019a \u00e9t\u00e9 engag\u00e9 ni conclu au cours de cette session ; une seule proc\u00e9dure de r\u00e9examen demeure en cours, concernant les m\u00e9dicaments contenant du fer administr\u00e9s par voie parent\u00e9rale.<\/p>\n
Sur le plan quantitatif, le PRAC a examin\u00e9 9 signaux de s\u00e9curit\u00e9, dont 5 nouveaux signaux ouverts et 4 signaux d\u00e9j\u00e0 en cours et cl\u00f4tur\u00e9s en octobre 2026. Il a par ailleurs trait\u00e9 85 rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (Periodic Safety Update Reports \u2013 PSUR) dans le cadre de proc\u00e9dures d\u2019\u00e9valuation unique : 55 ont abouti \u00e0 des recommandations pour des m\u00e9dicaments autoris\u00e9s par proc\u00e9dure centralis\u00e9e, 27 pour des m\u00e9dicaments autoris\u00e9s uniquement au niveau national dans les \u00c9tats membres de l\u2019UE, et 3 couvraient \u00e0 la fois des m\u00e9dicaments autoris\u00e9s par proc\u00e9dure centralis\u00e9e et nationale. Ces PSUR d\u00e9crivent l\u2019exp\u00e9rience mondiale de s\u00e9curit\u00e9 d\u2019un m\u00e9dicament sur une p\u00e9riode donn\u00e9e apr\u00e8s son autorisation et peuvent conduire \u00e0 des recommandations communes pour des produits partageant la m\u00eame substance active.<\/p>\n
Le comit\u00e9 a \u00e9galement examin\u00e9 49 plans de gestion des risques (Risk Management Plans \u2013 RMP) pour des m\u00e9dicaments autoris\u00e9s par proc\u00e9dure centralis\u00e9e. Parmi eux, 10 concernaient de nouveaux m\u00e9dicaments soumis pour autorisation de mise sur le march\u00e9, et 39 portaient sur des m\u00e9dicaments d\u00e9j\u00e0 autoris\u00e9s, leurs plans \u00e9tant actualis\u00e9s au fil de l\u2019acquisition de nouvelles donn\u00e9es de s\u00e9curit\u00e9. Parall\u00e8lement, 16 \u00e9tudes de s\u00e9curit\u00e9 post\u2011autorisation (Post\u2011Authorisation Safety Studies \u2013 PASS) ont \u00e9t\u00e9 analys\u00e9es : 7 protocoles d\u2019\u00e9tudes impos\u00e9es ou non impos\u00e9es ont \u00e9t\u00e9 examin\u00e9s, ainsi que les r\u00e9sultats de 9 \u00e9tudes de ce type.<\/p>\n
Les travaux du PRAC illustrent la structuration europ\u00e9enne de la pharmacovigilance autour de plusieurs outils compl\u00e9mentaires : d\u00e9tection et \u00e9valuation de signaux de s\u00e9curit\u00e9 \u00e0 partir de diverses sources, \u00e9valuation p\u00e9riodique de la balance b\u00e9n\u00e9fices\u2011risques via les PSUR, gestion proactive des risques \u00e0 travers les RMP, et approfondissement des connaissances de s\u00e9curit\u00e9 en conditions r\u00e9elles d\u2019utilisation gr\u00e2ce aux PASS. L\u2019ensemble de ces activit\u00e9s, centralis\u00e9es au niveau de l\u2019EMA et impliquant les \u00c9tats membres par l\u2019interm\u00e9diaire du PRAC, constitue un cadre de r\u00e9f\u00e9rence pour le suivi du risque m\u00e9dicamenteux en Europe, sans d\u00e9cision particuli\u00e8re nouvelle de r\u00e9examen de b\u00e9n\u00e9fice\u2011risque en octobre 2026. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" En octobre 2026, le comit\u00e9 pour l\u2019\u00e9valuation des risques en pharmacovigilance (PRAC) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a tenu sa r\u00e9union mensuelle consacr\u00e9e au suivi de la s\u00e9curit\u00e9 des […]<\/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":[31,2],"tags":[257,227,226],"class_list":["post-19986","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politiques-europeennes-sante-social-travail","category-sante-publique-et-systeme-de-soins","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19986","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=19986"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19986\/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=19986"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19986"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19986"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}