{"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-lanza-el-sistema-unificado-de-monitoreo-de-eventos-adversos-aems-para-agilizar-la-notificacion-de-seguridad-posterior-a-la-comercializacion","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-launches-unified-adverse-event-monitoring-system-aems-to-streamline-postmarket-safety-reporting\/","title":{"rendered":"La FDA lanza un sistema unificado de monitoreo de eventos adversos (A\u2026"},"content":{"rendered":"<p>En <strong>11 de marzo de 2026<\/strong>, el <strong>Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/strong> lanz\u00f3 el <strong>Sistema de Monitoreo de Eventos Adversos (AEMS)<\/strong>, una plataforma unificada dise\u00f1ada para mejorar <strong>gesti\u00f3n de datos de seguridad posteriores a la comercializaci\u00f3n<\/strong> en todas las categor\u00edas de productos regulados por la FDA. El sistema consolida m\u00faltiples bases de datos heredadas en una <strong>panel de informes \u00fanico en tiempo real<\/strong>, con migraci\u00f3n por fases y desmantelamiento del sistema programados hasta <strong>Mayo de 2026<\/strong>.<\/p>\n<div class=\"row\"  id=\"row-1929827575\">\n\n\t<div id=\"col-1189925351\" 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-1645067210\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1645067210 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-809918718\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-809918718 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El reci\u00e9n introducido <strong>AEMS<\/strong> reemplaza varios sistemas heredados de notificaci\u00f3n de eventos adversos, incluidos <strong>FAERS<\/strong>, <strong>VAERS<\/strong>, <strong>AERS<\/strong>, <strong>Maude<\/strong>, <strong>Jarabe de ma\u00edz de alta fructosa<\/strong>, y <strong>CTPAE<\/strong>, reuniendo todos los informes en un <strong>plataforma centralizada<\/strong>. Esta consolidaci\u00f3n permite <strong>publicaci\u00f3n en tiempo real de informes de eventos adversos<\/strong> en diversas categor\u00edas de productos, como medicamentos, productos biol\u00f3gicos, vacunas, cosm\u00e9ticos, dispositivos m\u00e9dicos, alimentos para consumo humano, suplementos diet\u00e9ticos, alimentos para animales y productos de tabaco.<\/p>\n<p>La plataforma presenta <strong>API mejoradas y herramientas de an\u00e1lisis<\/strong>, lo que permite una mejor\u00eda <strong>acceso e integraci\u00f3n de datos<\/strong> para funciones regulatorias, de calidad y de seguridad. Estas capacidades est\u00e1n dise\u00f1adas para brindar un monitoreo m\u00e1s eficiente, detecci\u00f3n de se\u00f1ales y seguimiento del cumplimiento.<\/p>\n<p>Los datos hist\u00f3ricos de los sistemas heredados ser\u00e1n... <strong>migr\u00f3 a AEMS<\/strong>, con <strong>desmantelamiento por fases<\/strong> de plataformas anteriores que ocurren a medida que avanza la migraci\u00f3n. Por el <strong>finales de mayo de 2026<\/strong>, Se espera que AEMS sirva como el <strong>Sistema principal para la notificaci\u00f3n y visibilidad de eventos adversos.<\/strong> en todos los sectores regulados por la FDA.<\/p>\n<p>Partes interesadas, incluidas <strong>fabricantes, profesionales de la salud y equipos de seguridad del paciente<\/strong>, Deben adaptar sus procesos de presentaci\u00f3n de informes para que se ajusten a los nuevos requisitos del sistema durante el per\u00edodo de transici\u00f3n.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1189925351 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-26172420\" 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>Plazos<\/h2>\n\t<div id=\"gap-371909455\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-371909455 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El <strong>La plataforma AEMS se lanz\u00f3 el 11 de marzo de 2026.<\/strong>, con <strong>migraci\u00f3n y desmantelamiento por fases<\/strong> de sistemas heredados que se espera que est\u00e9n terminados para el <strong>finales de mayo de 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-26172420 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1746357841\" 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>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-551469220\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-551469220 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n mejora <strong>transparencia y eficiencia<\/strong> en la vigilancia de seguridad posterior a la comercializaci\u00f3n mediante la habilitaci\u00f3n <strong>acceso en tiempo real a los datos de eventos adversos<\/strong> en todas las categor\u00edas de productos. El sistema centralizado admite <strong>integraci\u00f3n digital<\/strong>, mejora <strong>supervisi\u00f3n regulatoria<\/strong>, y simplifica <strong>procesos de gesti\u00f3n de datos<\/strong>, reduciendo la fragmentaci\u00f3n y mejorando la coherencia en la notificaci\u00f3n de seguridad.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1746357841 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1119876961\" 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>A qui\u00e9n afecta esto<\/h2>\n\t<div id=\"gap-1251923043\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1251923043 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Asuntos regulatorios<\/strong>, <strong>Seguro de calidad<\/strong>, <strong>Seguridad del paciente<\/strong>, y <strong>Equipos de farmacovigilancia<\/strong> marketing en todas las organizaciones <strong>Productos regulados por la FDA<\/strong>, incluyendo productos farmac\u00e9uticos, biol\u00f3gicos, dispositivos m\u00e9dicos, productos alimenticios y productos de tabaco.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1119876961 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-325522732\" 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>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-55099652\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-55099652 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deber\u00edan <strong>evaluar los flujos de trabajo actuales para la notificaci\u00f3n de eventos adversos<\/strong> y asegurar <strong>Compatibilidad del sistema con los requisitos de AEMS<\/strong>. Los equipos multifuncionales deben colaborar para <strong>actualizar protocolos internos<\/strong>, alinear <strong>procesos de integraci\u00f3n de datos<\/strong>, y prep\u00e1rese para <strong>Informes y monitoreo en tiempo real<\/strong> a medida que avanza la migraci\u00f3n por fases.<\/p>\n<p>A medida que los organismos reguladores mundiales siguen modernizando los sistemas de control de seguridad, mantener la coherencia con las infraestructuras de informaci\u00f3n en constante evoluci\u00f3n es fundamental para el cumplimiento normativo y la gesti\u00f3n de riesgos.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector, <a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reservar una demostraci\u00f3n<\/a> ahora.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-325522732 > .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-591632778\">\n\n\t<div id=\"col-1343168744\" 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>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1397306698\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1397306698 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 es el Sistema de Monitoreo de Eventos Adversos (AEMS) de la FDA?<\/h4>\n\t<div id=\"gap-1447540641\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1447540641 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es un <strong>plataforma centralizada<\/strong> para <strong>Notificaci\u00f3n y seguimiento de eventos adversos en tiempo real<\/strong> en todas las categor\u00edas de productos reguladas por la FDA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1343168744 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1097074531\" 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>\u00bfQu\u00e9 sistemas est\u00e1n siendo reemplazados por AEMS?<\/h4>\n\t<div id=\"gap-1828133097\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1828133097 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>AEMS reemplaza <strong>FAERS<\/strong>, <strong>VAERS<\/strong>, <strong>AERS<\/strong>, <strong>Maude<\/strong>, <strong>Jarabe de ma\u00edz de alta fructosa<\/strong>, y <strong>CTPAE<\/strong>, consolid\u00e1ndolos en un \u00fanico sistema.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1097074531 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1014106709\" 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>\u00bfCu\u00e1ndo se completar\u00e1 la transici\u00f3n a AEMS?<\/h4>\n\t<div id=\"gap-695884528\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-695884528 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El <strong>migraci\u00f3n y desmantelamiento por fases<\/strong> Se espera que los sistemas heredados se completen para el <strong>finales de mayo de 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1014106709 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-730549549\" 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>\u00bfC\u00f3mo puede RegASK ayudar a las organizaciones a adaptarse a AEMS?<\/h4>\n\t<div id=\"gap-1683018758\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1683018758 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\">RegASK <\/a>ayuda a las organizaciones <strong>Seguimiento de los cambios en el sistema regulatorio<\/strong>, alinear <strong>flujos de trabajo de informes<\/strong>, y simplificar <strong>procesos de cumplimiento<\/strong>, lo que garantiza una adaptaci\u00f3n perfecta a los nuevos requisitos de control de seguridad.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-730549549 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 11 de marzo de 2026, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) lanz\u00f3 el Sistema de Monitoreo de Eventos Adversos (AEMS, por sus siglas en ingl\u00e9s), una plataforma unificada dise\u00f1ada para mejorar la gesti\u00f3n de datos de seguridad posteriores a la comercializaci\u00f3n en todas las categor\u00edas de productos regulados por la FDA. El sistema consolida m\u00faltiples bases de datos heredadas en un \u00fanico panel de informes en tiempo real, con una migraci\u00f3n gradual y la desactivaci\u00f3n del sistema programadas hasta mayo de 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 v28.0 (Yoast SEO v28.2) - 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 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