{"id":9714,"date":"2026-03-25T16:42:45","date_gmt":"2026-03-25T08:42:45","guid":{"rendered":"https:\/\/regask.com\/?p=9714"},"modified":"2026-03-25T16:43:42","modified_gmt":"2026-03-25T08:43:42","slug":"la-fda-lance-un-systeme-unifie-de-surveillance-des-evenements-indesirables-aems-pour-rationaliser-les-rapports-de-securite-apres-la-mise-sur-le-marche","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-launches-unified-adverse-event-monitoring-system-aems-to-streamline-postmarket-safety-reporting\/","title":{"rendered":"La FDA lance un syst\u00e8me unifi\u00e9 de surveillance des \u00e9v\u00e9nements ind\u00e9sirables (A\u2026"},"content":{"rendered":"<p>Sur <strong>11 mars 2026<\/strong>, le <strong>Administration am\u00e9ricaine des aliments et des m\u00e9dicaments (FDA)<\/strong> a lanc\u00e9 le <strong>Syst\u00e8me de surveillance des \u00e9v\u00e9nements ind\u00e9sirables (AEMS)<\/strong>, une plateforme unifi\u00e9e con\u00e7ue pour am\u00e9liorer <strong>gestion des donn\u00e9es de s\u00e9curit\u00e9 post-commercialisation<\/strong> pour toutes les cat\u00e9gories de produits r\u00e9glement\u00e9es par la FDA. Le syst\u00e8me consolide plusieurs bases de donn\u00e9es existantes en une seule. <strong>tableau de bord de reporting unique en temps r\u00e9el<\/strong>, avec une migration progressive et une mise hors service du syst\u00e8me pr\u00e9vues jusqu&#039;\u00e0 <strong>Mai 2026<\/strong>.<\/p>\n<div class=\"row\"  id=\"row-1421667750\">\n\n\t<div id=\"col-1202397736\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1020247531\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1020247531 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-1020163502\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1020163502 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le nouveau introduit <strong>AEMS<\/strong> remplace plusieurs anciens syst\u00e8mes de d\u00e9claration des \u00e9v\u00e9nements ind\u00e9sirables, notamment <strong>FAERS<\/strong>, <strong>VAERS<\/strong>, <strong>AERS<\/strong>, <strong>MAUDE<\/strong>, <strong>HFCS<\/strong>, et <strong>CTPAE<\/strong>, en centralisant tous les rapports dans un <strong>plateforme centralis\u00e9e<\/strong>. Cette consolidation permet <strong>publication en temps r\u00e9el des rapports d&#039;\u00e9v\u00e9nements ind\u00e9sirables<\/strong> dans des cat\u00e9gories de produits telles que les m\u00e9dicaments, les produits biologiques, les vaccins, les cosm\u00e9tiques, les dispositifs m\u00e9dicaux, les aliments pour humains, les compl\u00e9ments alimentaires, les aliments pour animaux et les produits du tabac.<\/p>\n<p>La plateforme introduit <strong>API am\u00e9lior\u00e9es et outils d&#039;analyse<\/strong>, permettant une am\u00e9lioration <strong>acc\u00e8s aux donn\u00e9es et int\u00e9gration<\/strong> pour les fonctions r\u00e9glementaires, de qualit\u00e9 et de s\u00e9curit\u00e9. Ces fonctionnalit\u00e9s visent \u00e0 faciliter une surveillance, une d\u00e9tection des signaux et un suivi de la conformit\u00e9 plus efficaces.<\/p>\n<p>Les donn\u00e9es historiques issues des syst\u00e8mes existants seront <strong>migration vers AEMS<\/strong>, avec <strong>d\u00e9classement progressif<\/strong> des plateformes pr\u00e9c\u00e9dentes se produisant au fur et \u00e0 mesure de la migration. Par le <strong>fin mai 2026<\/strong>, AEMS devrait servir de <strong>Syst\u00e8me principal de signalement et de visibilit\u00e9 des \u00e9v\u00e9nements ind\u00e9sirables<\/strong> dans tous les secteurs r\u00e9glement\u00e9s par la FDA.<\/p>\n<p>Les parties prenantes, notamment <strong>fabricants, professionnels de la sant\u00e9 et \u00e9quipes de s\u00e9curit\u00e9 des patients<\/strong>, doivent adapter leurs processus de reporting pour se conformer aux nouvelles exigences du syst\u00e8me pendant la p\u00e9riode de transition.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1202397736 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-204171136\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u00c9ch\u00e9ances<\/h2>\n\t<div id=\"gap-774130940\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-774130940 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le <strong>La plateforme AEMS a \u00e9t\u00e9 lanc\u00e9e le 11 mars 2026.<\/strong>, avec <strong>migration et mise hors service progressives<\/strong> des syst\u00e8mes existants dont l&#039;ach\u00e8vement est pr\u00e9vu d&#039;ici <strong>fin mai 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-204171136 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1724786299\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-1660825194\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1660825194 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour am\u00e9liore <strong>transparence et efficacit\u00e9<\/strong> en mati\u00e8re de surveillance de la s\u00e9curit\u00e9 apr\u00e8s commercialisation, en permettant <strong>acc\u00e8s en temps r\u00e9el aux donn\u00e9es sur les \u00e9v\u00e9nements ind\u00e9sirables<\/strong> pour toutes les cat\u00e9gories de produits. Le syst\u00e8me centralis\u00e9 prend en charge <strong>int\u00e9gration num\u00e9rique<\/strong>, am\u00e9liore <strong>surveillance r\u00e9glementaire<\/strong>, et rationalise <strong>processus de gestion des donn\u00e9es<\/strong>, r\u00e9duisant ainsi la fragmentation et am\u00e9liorant la coh\u00e9rence des rapports de s\u00e9curit\u00e9.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1724786299 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1315706395\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Qui est concern\u00e9 ?<\/h2>\n\t<div id=\"gap-1869513229\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1869513229 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>Affaires r\u00e9glementaires<\/strong>, <strong>Assurance qualit\u00e9<\/strong>, <strong>S\u00e9curit\u00e9 des patients<\/strong>, et <strong>\u00e9quipes de pharmacovigilance<\/strong> marketing interorganisationnel <strong>produits r\u00e9glement\u00e9s par la FDA<\/strong>, notamment les produits pharmaceutiques, les produits biologiques, les dispositifs m\u00e9dicaux, les produits alimentaires et les produits du tabac.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1315706395 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-215624833\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-1213529948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1213529948 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient <strong>\u00e9valuer les flux de travail actuels de signalement des \u00e9v\u00e9nements ind\u00e9sirables<\/strong> et assurer <strong>Compatibilit\u00e9 du syst\u00e8me avec les exigences AEMS<\/strong>. Les \u00e9quipes transversales devraient collaborer pour <strong>mise \u00e0 jour des protocoles internes<\/strong>, aligner <strong>processus d&#039;int\u00e9gration des donn\u00e9es<\/strong>, et pr\u00e9parez-vous \u00e0 <strong>rapports et surveillance en temps r\u00e9el<\/strong> \u00e0 mesure que la migration par \u00e9tapes progresse.<\/p>\n<p>Alors que les organismes de r\u00e9glementation mondiaux continuent de moderniser les syst\u00e8mes de surveillance de la s\u00e9curit\u00e9, il est essentiel, pour la conformit\u00e9 et la gestion des risques, de maintenir l&#039;alignement avec les infrastructures de d\u00e9claration en constante \u00e9volution.<\/p>\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentique, qui permet aux organisations internationales des secteurs fortement r\u00e9glement\u00e9s, tels que les produits de consommation et les sciences de la vie, d&#039;anticiper les complexit\u00e9s r\u00e9glementaires. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9server une d\u00e9mo<\/a> maintenant.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-215624833 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1880451545\">\n\n\t<div id=\"col-1916364463\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQ<\/h3>\n\t<div id=\"gap-1298337706\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1298337706 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Qu\u2019est-ce que le syst\u00e8me de surveillance des \u00e9v\u00e9nements ind\u00e9sirables de la FDA (AEMS)\u00a0?<\/h4>\n\t<div id=\"gap-1213686621\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1213686621 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>C&#039;est un <strong>plateforme centralis\u00e9e<\/strong> pour <strong>signalement et surveillance en temps r\u00e9el des \u00e9v\u00e9nements ind\u00e9sirables<\/strong> dans toutes les cat\u00e9gories de produits r\u00e9glement\u00e9es par la FDA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1916364463 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1147866789\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quels syst\u00e8mes sont remplac\u00e9s par AEMS\u00a0?<\/h4>\n\t<div id=\"gap-1449017382\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1449017382 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>AEMS remplace <strong>FAERS<\/strong>, <strong>VAERS<\/strong>, <strong>AERS<\/strong>, <strong>MAUDE<\/strong>, <strong>HFCS<\/strong>, et <strong>CTPAE<\/strong>, en les regroupant dans un syst\u00e8me unique.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1147866789 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-678390912\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quand la transition vers le syst\u00e8me AEMS sera-t-elle achev\u00e9e\u00a0?<\/h4>\n\t<div id=\"gap-298982404\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-298982404 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le <strong>migration et mise hors service progressives<\/strong> Les syst\u00e8mes existants devraient \u00eatre achev\u00e9s d&#039;ici \u00e0 <strong>fin mai 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-678390912 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1326760243\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Comment le programme RegASK peut-il aider les organisations \u00e0 s&#039;adapter aux syst\u00e8mes de gestion des urgences automatis\u00e9s (AEMS)\u00a0?<\/h4>\n\t<div id=\"gap-1568882789\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1568882789 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\">RegASK <\/a>aide les organisations <strong>Suivre les changements du syst\u00e8me r\u00e9glementaire<\/strong>, aligner <strong>flux de travail de reporting<\/strong>, et rationaliser <strong>processus de conformit\u00e9<\/strong>, assurant ainsi une adaptation sans faille aux nouvelles exigences en mati\u00e8re de surveillance de la s\u00e9curit\u00e9.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1326760243 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On March 11, 2026, the U.S. Food and Drug Administration (FDA) launched the Adverse Event Monitoring System (AEMS), a unified platform designed to enhance postmarket safety data management across all FDA-regulated product categories. The system consolidates multiple legacy databases into a single real-time reporting dashboard, with phased migration and system decommissioning scheduled through May 2026.<\/p>","protected":false},"author":32,"featured_media":9715,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33],"tags":[],"class_list":["post-9714","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Launches Unified Adverse Event Monitoring System Overview<\/title>\n<meta name=\"description\" content=\"The FDA launches a unified adverse event monitoring system to enhance postmarket safety reporting for all regulated products.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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