{"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":"la-ema-publica-recomendaciones-practicas-actualizadas-sobre-las-senales-de-seguridad-para-medicamentos-autorizados-a-nivel-central-y-nacional","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines\/","title":{"rendered":"La EMA publica las actualizaciones de seguridad del PRAC de junio de 2025 para los\u2026"},"content":{"rendered":"<p data-start=\"375\" data-end=\"742\">La Agencia Europea de Medicamentos (EMA) ha publicado recomendaciones actualizadas sobre se\u00f1ales de seguridad de su comit\u00e9 PRAC sobre <strong>2 de junio de 2025<\/strong>.<br class=\"yoast-text-mark\" data-start=\"285\" data-end=\"288\" \/>Esta actualizaci\u00f3n refleja los esfuerzos continuos de la EMA para <strong>mejorar la monitorizaci\u00f3n de la farmacovigilancia<\/strong> y refuerza la vigilancia posterior a la comercializaci\u00f3n de medicamentos autorizados en toda la Uni\u00f3n Europea (UE).<\/p>\n<p data-start=\"744\" data-end=\"961\">Estas directrices revisadas tienen por objeto mejorar la supervisi\u00f3n de <strong>reacciones adversas a medicamentos (RAM)<\/strong>. Ayudan a garantizar que el marketing <strong>titulares de autorizaciones de comercializaci\u00f3n (MAH)<\/strong> Mant\u00e9ngase en conformidad con la evoluci\u00f3n <strong>normas de seguridad de los medicamentos<\/strong>.<\/p>\n<h4 data-start=\"968\" data-end=\"1029\">\ud83d\udd0d Aspectos destacados de las recomendaciones del PRAC de junio de 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>Se\u00f1ales de seguridad actualizadas:<\/strong> Las recomendaciones cubren actualizaciones de la informaci\u00f3n del producto en m\u00faltiples <strong>\u00e1reas terap\u00e9uticas<\/strong>, incluyendo oncolog\u00eda, tratamientos cardiovasculares, vacunas y otros medicamentos de alta prioridad. Estos se alinean con los hallazgos emergentes de farmacovigilancia en toda la UE.<\/p>\n<\/li>\n<li data-start=\"1318\" data-end=\"1688\">\n<p data-start=\"1320\" data-end=\"1370\"><strong>Medicamentos autorizados a nivel central frente a medicamentos autorizados a nivel nacional:<\/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\">Para <strong data-start=\"1379\" data-end=\"1413\">medicamentos autorizados centralmente<\/strong>, cualquier cambio recomendado debe ser validado por el <strong data-start=\"1464\" data-end=\"1521\">Comit\u00e9 de Medicamentos de Uso Humano (CHMP)<\/strong>.<\/p>\n<\/li>\n<li data-start=\"1525\" data-end=\"1688\">\n<p data-start=\"1527\" data-end=\"1688\">Para <strong data-start=\"1531\" data-end=\"1565\">productos autorizados a nivel nacional<\/strong>, la implementaci\u00f3n cae bajo la <strong data-start=\"1598\" data-end=\"1687\">Grupo de Coordinaci\u00f3n para el Reconocimiento Mutuo y los Procedimientos Descentralizados \u2013 Humanos (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\">Recordatorio de cumplimiento normativo<\/strong>:Los titulares de autorizaciones de comercializaci\u00f3n deben <strong data-start=\"1765\" data-end=\"1803\">Revisar peri\u00f3dicamente las publicaciones del PRAC<\/strong> y actualizar r\u00e1pidamente el etiquetado del producto, los folletos u otra informaci\u00f3n de seguridad para seguir cumpliendo con los \u00faltimos protocolos de monitoreo de seguridad.<\/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\">Aclaraci\u00f3n de las se\u00f1ales de seguridad<\/strong>Es importante destacar que la identificaci\u00f3n de una se\u00f1al de seguridad no confirma una relaci\u00f3n causal entre un medicamento y un evento adverso. M\u00e1s bien, indica la necesidad de una evaluaci\u00f3n cient\u00edfica adicional o de tomar medidas preventivas.<\/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\">Implementaci\u00f3n multiling\u00fce<\/strong>La informaci\u00f3n actualizada del producto est\u00e1 disponible en todos los idiomas oficiales de la UE, incluidos noruego e island\u00e9s, para favorecer una implementaci\u00f3n armonizada en todos los estados miembros.<\/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\">Transparencia de la farmacovigilancia<\/strong>: A <strong data-start=\"2456\" data-end=\"2497\">lista acumulativa de todas las se\u00f1ales de seguridad<\/strong> Revisado por PRAC desde <strong data-start=\"2521\" data-end=\"2539\">Septiembre de 2012<\/strong> permanece accesible p\u00fablicamente, ofreciendo a los reguladores y a las partes interesadas en la atenci\u00f3n m\u00e9dica un contexto hist\u00f3rico y visibilidad de tendencias.<\/p>\n<\/li>\n<\/ul>\n<hr data-start=\"2659\" data-end=\"2662\" \/>\n<h4 data-start=\"2664\" data-end=\"2708\">\ud83c\udf10 Por qu\u00e9 esto es importante para los equipos reguladores<\/h4>\n<p data-start=\"2710\" data-end=\"2948\">Estas actualizaciones desempe\u00f1an un papel fundamental para permitir <strong data-start=\"2757\" data-end=\"2808\">Implementaci\u00f3n m\u00e1s r\u00e1pida de cambios relacionados con la seguridad. <\/strong>Mejorando <strong data-start=\"2820\" data-end=\"2847\">transparencia regulatoria<\/strong>, y apoyando <strong data-start=\"2864\" data-end=\"2892\">acceso equitativo de los pacientes<\/strong> a los datos m\u00e1s actualizados sobre seguridad de medicamentos en toda la UE.<\/p>\n<p data-start=\"2950\" data-end=\"3107\">Mantenerse informado de estos cambios es esencial para los profesionales regulatorios que gestionan <strong data-start=\"3034\" data-end=\"3056\">Cumplimiento de la normativa sobre medicamentos de la UE<\/strong>, <strong data-start=\"3058\" data-end=\"3078\">actualizaciones de etiquetado<\/strong>, y <strong data-start=\"3084\" data-end=\"3106\">comunicaci\u00f3n de riesgos<\/strong>.<\/p>\n<hr data-start=\"3109\" data-end=\"3112\" \/>\n<h4 data-start=\"3114\" data-end=\"3161\">\ud83d\udce5 \u00bfQuieres estar al tanto de las actualizaciones de seguridad de la UE?<\/h4>\n<p data-start=\"3163\" data-end=\"3387\">Visita el <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\">sitio web oficial de la EMA<\/a> para obtener la lista completa de actualizaciones de se\u00f1ales de seguridad y orientaci\u00f3n espec\u00edfica del producto.<\/p>\n<p data-start=\"3389\" data-end=\"3534\">O explorar c\u00f3mo <a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a>La plataforma de inteligencia regulatoria impulsada por IA de puede ayudarlo a monitorear los cambios en la farmacovigilancia global en tiempo real.<\/p>","protected":false},"excerpt":{"rendered":"<p>The European Medicines Agency (EMA) has released updated safety signal recommendations from its PRAC committee on June 2, 2025.This update reflects the EMA\u2019s continued efforts to enhance pharmacovigilance monitoring and strengthens post-marketing surveillance for authorized medicines across the European Union (EU). These revised guidelines aim to improve oversight of adverse drug reactions (ADRs). They help&#8230;<\/p>","protected":false},"author":30,"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 v27.3 (Yoast SEO v27.5) - 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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