{"id":8350,"date":"2025-06-23T16:21:17","date_gmt":"2025-06-23T08:21:17","guid":{"rendered":"https:\/\/regask.com\/?p=8350"},"modified":"2025-06-24T14:57:55","modified_gmt":"2025-06-24T06:57:55","slug":"lema-publie-des-recommandations-pratiques-mises-a-jour-sur-les-signaux-de-securite-pour-les-medicaments-autorises-au-niveau-central-et-national","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines\/","title":{"rendered":"L&#039;EMA publie les mises \u00e0 jour de s\u00e9curit\u00e9 du PRAC de juin 2025 pour les m\u00e9dicaments autoris\u00e9s par l&#039;UE."},"content":{"rendered":"<p data-start=\"375\" data-end=\"742\">L&#039;Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 des recommandations de s\u00e9curit\u00e9 mises \u00e0 jour de son comit\u00e9 PRAC sur <strong>2 juin 2025<\/strong>.<br class=\"yoast-text-mark\" data-start=\"285\" data-end=\"288\" \/>Cette mise \u00e0 jour refl\u00e8te les efforts continus de l&#039;EMA pour <strong>am\u00e9liorer la surveillance de la pharmacovigilance<\/strong> et renforce la surveillance post-commercialisation des m\u00e9dicaments autoris\u00e9s dans toute l\u2019Union europ\u00e9enne (UE).<\/p>\n<p data-start=\"744\" data-end=\"961\">Ces lignes directrices r\u00e9vis\u00e9es visent \u00e0 am\u00e9liorer la surveillance de <strong>effets ind\u00e9sirables des m\u00e9dicaments (EIM)<\/strong>Ils contribuent \u00e0 garantir que le marketing <strong>titulaires d&#039;autorisation de mise sur le march\u00e9 (TAMM)<\/strong> rester conforme \u00e0 l&#039;\u00e9volution <strong>r\u00e9glementation sur la s\u00e9curit\u00e9 des m\u00e9dicaments<\/strong>.<\/p>\n<h4 data-start=\"968\" data-end=\"1029\">\ud83d\udd0d Principaux points saillants des recommandations du PRAC de juin 2025<\/h4>\n<ul data-start=\"1031\" data-end=\"2657\">\n<li data-start=\"1031\" data-end=\"1316\">\n<p data-start=\"1033\" data-end=\"1316\"><strong>Signaux de s\u00e9curit\u00e9 mis \u00e0 jour\u00a0:<\/strong> Les recommandations couvrent les mises \u00e0 jour des informations sur les produits sur plusieurs <strong>domaines th\u00e9rapeutiques<\/strong>, notamment en oncologie, en traitements cardiovasculaires, en vaccins et autres m\u00e9dicaments hautement prioritaires. Ces mesures sont conformes aux nouvelles conclusions de pharmacovigilance dans l&#039;UE.<\/p>\n<\/li>\n<li data-start=\"1318\" data-end=\"1688\">\n<p data-start=\"1320\" data-end=\"1370\"><strong>M\u00e9dicaments autoris\u00e9s au niveau central ou national\u00a0:<\/strong><\/p>\n<ul data-start=\"1373\" data-end=\"1688\">\n<li data-start=\"1373\" data-end=\"1522\">\n<p data-start=\"1375\" data-end=\"1522\">Pour <strong data-start=\"1379\" data-end=\"1413\">m\u00e9dicaments autoris\u00e9s de mani\u00e8re centralis\u00e9e<\/strong>, toute modification recommand\u00e9e doit \u00eatre valid\u00e9e par le <strong data-start=\"1464\" data-end=\"1521\">Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP)<\/strong>.<\/p>\n<\/li>\n<li data-start=\"1525\" data-end=\"1688\">\n<p data-start=\"1527\" data-end=\"1688\">Pour <strong data-start=\"1531\" data-end=\"1565\">produits autoris\u00e9s au niveau national<\/strong>, la mise en \u0153uvre rel\u00e8ve de la <strong data-start=\"1598\" data-end=\"1687\">Groupe de coordination pour la reconnaissance mutuelle et les proc\u00e9dures d\u00e9centralis\u00e9es \u2013 Humain (CMDh)<\/strong>.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li data-start=\"1690\" data-end=\"1943\">\n<p data-start=\"1692\" data-end=\"1943\"><strong data-start=\"1692\" data-end=\"1726\">Rappel de conformit\u00e9 r\u00e9glementaire<\/strong>: Les titulaires d&#039;autorisation de mise sur le march\u00e9 doivent <strong data-start=\"1765\" data-end=\"1803\">consulter r\u00e9guli\u00e8rement les publications du PRAC<\/strong> et mettre \u00e0 jour rapidement l&#039;\u00e9tiquetage des produits, les notices ou autres informations de s\u00e9curit\u00e9 pour rester conforme aux derniers protocoles de surveillance de la s\u00e9curit\u00e9.<\/p>\n<\/li>\n<li data-start=\"1945\" data-end=\"2204\">\n<p data-start=\"1947\" data-end=\"2204\"><strong data-start=\"1947\" data-end=\"1976\">Clarification des signaux de s\u00e9curit\u00e9<\/strong>Il est important de noter que l&#039;identification d&#039;un signal de s\u00e9curit\u00e9 ne confirme pas l&#039;existence d&#039;un lien de causalit\u00e9 entre un m\u00e9dicament et un \u00e9v\u00e9nement ind\u00e9sirable. Elle indique plut\u00f4t la n\u00e9cessit\u00e9 d&#039;une \u00e9valuation scientifique plus approfondie ou de mesures de pr\u00e9caution.<\/p>\n<\/li>\n<li data-start=\"2206\" data-end=\"2414\">\n<p data-start=\"2208\" data-end=\"2414\"><strong data-start=\"2208\" data-end=\"2239\">Mise en \u0153uvre multilingue<\/strong>:Les informations mises \u00e0 jour sur les produits sont disponibles dans toutes les langues officielles de l&#039;UE, y compris le norv\u00e9gien et l&#039;islandais, afin de soutenir une mise en \u0153uvre harmonis\u00e9e dans tous les \u00c9tats membres.<\/p>\n<\/li>\n<li data-start=\"2416\" data-end=\"2657\">\n<p data-start=\"2418\" data-end=\"2657\"><strong data-start=\"2418\" data-end=\"2452\">Transparence en mati\u00e8re de pharmacovigilance<\/strong>: UN <strong data-start=\"2456\" data-end=\"2497\">liste cumulative de tous les signaux de s\u00e9curit\u00e9<\/strong> examin\u00e9 par le PRAC depuis <strong data-start=\"2521\" data-end=\"2539\">Septembre 2012<\/strong> reste accessible au public, offrant aux r\u00e9gulateurs et aux acteurs de la sant\u00e9 un contexte historique et une visibilit\u00e9 des tendances.<\/p>\n<\/li>\n<\/ul>\n<hr data-start=\"2659\" data-end=\"2662\" \/>\n<h4 data-start=\"2664\" data-end=\"2708\">\ud83c\udf10 Pourquoi cela est important pour les \u00e9quipes r\u00e9glementaires<\/h4>\n<p data-start=\"2710\" data-end=\"2948\">Ces mises \u00e0 jour jouent un r\u00f4le essentiel en permettant <strong data-start=\"2757\" data-end=\"2808\">une mise en \u0153uvre plus rapide des changements li\u00e9s \u00e0 la s\u00e9curit\u00e9. <\/strong>Am\u00e9lioration <strong data-start=\"2820\" data-end=\"2847\">transparence r\u00e9glementaire<\/strong>, et soutenant <strong data-start=\"2864\" data-end=\"2892\">acc\u00e8s \u00e9quitable aux patients<\/strong> aux donn\u00e9es de s\u00e9curit\u00e9 des m\u00e9dicaments les plus r\u00e9centes dans l\u2019UE.<\/p>\n<p data-start=\"2950\" data-end=\"3107\">Rester inform\u00e9 de ces changements est essentiel pour les professionnels de la r\u00e9glementation qui g\u00e8rent <strong data-start=\"3034\" data-end=\"3056\">Conformit\u00e9 des r\u00e9glementations de l&#039;UE en mati\u00e8re de drogues<\/strong>, <strong data-start=\"3058\" data-end=\"3078\">mises \u00e0 jour de l&#039;\u00e9tiquetage<\/strong>, et <strong data-start=\"3084\" data-end=\"3106\">communication des risques<\/strong>.<\/p>\n<hr data-start=\"3109\" data-end=\"3112\" \/>\n<h4 data-start=\"3114\" data-end=\"3161\">\ud83d\udce5 Vous souhaitez rester inform\u00e9 des mises \u00e0 jour de s\u00e9curit\u00e9 de l\u2019UE\u00a0?<\/h4>\n<p data-start=\"3163\" data-end=\"3387\">Visitez le <a class=\"\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/signal-management\/prac-recommendations-safety-signals\" target=\"_new\" rel=\"noopener\" data-start=\"3173\" data-end=\"3313\">site officiel de l&#039;EMA<\/a> pour la liste compl\u00e8te des mises \u00e0 jour des signaux de s\u00e9curit\u00e9 et des conseils sp\u00e9cifiques au produit.<\/p>\n<p data-start=\"3389\" data-end=\"3534\">Ou explorez comment <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a>La plateforme de renseignement r\u00e9glementaire bas\u00e9e sur l&#039;IA peut vous aider \u00e0 surveiller les changements mondiaux en mati\u00e8re de pharmacovigilance en temps r\u00e9el.<\/p>","protected":false},"excerpt":{"rendered":"<p>L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 le 2 juin 2025 des recommandations actualis\u00e9es de son comit\u00e9 PRAC concernant les signaux de s\u00e9curit\u00e9. Cette mise \u00e0 jour t\u00e9moigne des efforts continus de l\u2019EMA pour renforcer la surveillance de la pharmacovigilance et la surveillance post-commercialisation des m\u00e9dicaments autoris\u00e9s dans l\u2019ensemble de l\u2019Union europ\u00e9enne (UE). Ces lignes directrices r\u00e9vis\u00e9es visent \u00e0 am\u00e9liorer la surveillance des effets ind\u00e9sirables des m\u00e9dicaments. Elles contribuent \u00e0\u2026<\/p>","protected":false},"author":43,"featured_media":8413,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[538,35],"tags":[225,227,496,497],"class_list":["post-8350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-european-union","category-pharma-biotech-latest-insights","tag-drug-safety","tag-pharmacovigilance","tag-market-authorization-regs","tag-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EMA Releases June 2025 PRAC Safety Updates for EU-Authorized Medicines | RegASK<\/title>\n<meta name=\"description\" content=\"Discover the latest EMA PRAC safety updates for centrally and nationally authorized medicines, effective June 2025 across the EU.\" \/>\n<meta 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