{"id":9534,"date":"2026-02-24T22:52:46","date_gmt":"2026-02-24T14:52:46","guid":{"rendered":"https:\/\/regask.com\/?p=9534"},"modified":"2026-02-25T16:46:25","modified_gmt":"2026-02-25T08:46:25","slug":"la-ema-publica-una-guia-final-sobre-la-gestion-del-riesgo-de-impurezas-elementales-en-medicamentos-veterinarios","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/ema-issues-final-elemental-impurity-risk-management-guidance-for-veterinary-medicinal-products\/","title":{"rendered":"La EMA publica la gu\u00eda final sobre gesti\u00f3n del riesgo de impurezas elementales\u2026"},"content":{"rendered":"<p>En <strong>20 de febrero de 2026,<\/strong> el <strong>Agencia Europea de Medicamentos<\/strong> publicado <strong>orientaci\u00f3n final<\/strong> establecer requisitos de gesti\u00f3n de riesgos para <strong>impurezas elementales en todos los productos medicinales veterinarios (VMP),<\/strong> incluido <strong>productos biol\u00f3gicos, inmunol\u00f3gicos como vacunas y terapias novedosas.<\/strong> La gu\u00eda se aplica a los fabricantes responsables de la calidad, la seguridad y el cumplimiento normativo de los productos farmac\u00e9uticos veterinarios utilizados en animales.<\/p>\n<div class=\"row\"  id=\"row-1306694412\">\n\n\t<div id=\"col-1175939160\" 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-54821716\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-54821716 {\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-383237965\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-383237965 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La orientaci\u00f3n establece un enfoque armonizado para la <strong>identificaci\u00f3n, evaluaci\u00f3n y control de impurezas elementales,<\/strong> incluidos los metales pesados, en todas las categor\u00edas de VMP. Aclara que los fabricantes deben aplicar <strong>principios de gesti\u00f3n de riesgos alineados con los requisitos de la Farmacopea Europea,<\/strong> incluso para tipos de productos veterinarios que anteriormente estaban excluidos de directrices comparables para productos medicinales humanos.<\/p>\n<p>El documento establece expectativas sobre c\u00f3mo<strong> Se deben realizar y documentar evaluaciones de riesgos,<\/strong> incluido el requisito de que los resultados de la evaluaci\u00f3n de riesgos se resuman en<strong> expedientes reglamentarios para la presentaci\u00f3n de nuevos productos.<\/strong> En el caso de los productos existentes, solo se requieren actualizaciones del expediente cuando la reevaluaci\u00f3n d\u00e9 lugar a cambios en la informaci\u00f3n presentada.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1175939160 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1893794124\" 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-2021552928\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2021552928 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Implementaci\u00f3n por fases y flexibilidad<\/h2>\n\t<div id=\"gap-322171906\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-322171906 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Para <strong>medicamentos veterinarios inmunol\u00f3gicos,<\/strong> Como las vacunas, la gu\u00eda introduce una <strong>enfoque de implementaci\u00f3n por fases.<\/strong> Esto refleja su perfil de riesgo generalmente bajo y proporciona flexibilidad regulatoria adicional manteniendo al mismo tiempo la alineaci\u00f3n con los objetivos generales de calidad y seguridad.<\/p>\n<p>La gu\u00eda tambi\u00e9n permite <strong>valores de exposici\u00f3n diaria permitidos<\/strong> para que las impurezas elementales se recalculen cuando est\u00e9 justificado cient\u00edficamente, teniendo en cuenta <strong>especie animal, peso corporal, volumen de dosis y frecuencia de administraci\u00f3n.<\/strong> En los casos en que la prueba directa no sea factible o pertinente, <strong>datos bibliogr\u00e1ficos<\/strong> Puede utilizarse para respaldar conclusiones de riesgo insignificante.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1893794124 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2099746518\" 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>Fecha l\u00edmite para comentarios<\/h2>\n\t<div id=\"gap-375930656\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-375930656 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>No aplicable.<\/strong> Esta gu\u00eda se publica como <strong>final<\/strong> y no incluye un plazo de consulta o retroalimentaci\u00f3n p\u00fablica.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2099746518 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1531368018\" 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-1670780932\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1670780932 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda proporciona <strong>claridad regulatoria<\/strong> Al confirmar que la gesti\u00f3n del riesgo de impurezas elementales se aplica de forma uniforme en todos los medicamentos veterinarios. Al alinear las expectativas con las existentes. <strong>Normas de la Farmacopea Europea,<\/strong> Apoya la alineaci\u00f3n digital y procesal dentro de los sistemas de calidad, promueve la eficiencia en las presentaciones regulatorias y limita la carga adicional al introducir flexibilidad e implementaci\u00f3n gradual cuando est\u00e9 justificado cient\u00edficamente.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1531368018 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-386606907\" 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>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-1026832308\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1026832308 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Asuntos Regulatorios, Garant\u00eda de Calidad, Desarrollo Farmac\u00e9utico,<\/strong> y <strong>Fabricaci\u00f3n<\/strong> equipos involucrados en el desarrollo, presentaci\u00f3n y gesti\u00f3n del ciclo de vida de productos medicinales veterinarios, incluidas vacunas y terapias avanzadas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-386606907 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-109948097\" 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-156357444\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-156357444 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los fabricantes deber\u00edan revisar las normas existentes <strong>procesos de evaluaci\u00f3n de riesgos de impurezas elementales<\/strong> En todas las carteras de productos veterinarios, incluidos los productos que anteriormente se consideraban fuera del alcance. Se deben evaluar los expedientes regulatorios para determinar si se requieren actualizaciones tras la reevaluaci\u00f3n y las oportunidades para aprovecharlas.<strong> evidencia bibliogr\u00e1fica<\/strong> Debe considerarse la realizaci\u00f3n de pruebas directas cuando no resulte pr\u00e1ctico.<\/p>\n<p>A medida que las organizaciones se adaptan a estas expectativas actualizadas de la EMA, <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Puede respaldar a los equipos al monitorear continuamente las pautas regulatorias veterinarias y traducir requisitos complejos en flujos de trabajo de cumplimiento procesables. <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujo de trabajo con inteligencia artificial (IA) que permite a las organizaciones globales en sectores altamente regulados, incluidos productos de consumo y ciencias biol\u00f3gicas, navegar de manera proactiva en panoramas regulatorios complejos. <strong>Al combinar la IA avanzada de Agentic con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> 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=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-109948097 > .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-1972068646\">\n\n\t<div id=\"col-1255399601\" 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-1945977863\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1945977863 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 son las impurezas elementales en los medicamentos veterinarios?<\/h4>\n\t<div id=\"gap-328214397\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-328214397 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las impurezas elementales son elementos inorg\u00e1nicos no deseados, como metales pesados, que pueden estar presentes en los productos medicinales veterinarios y requieren evaluaci\u00f3n y control para garantizar la seguridad del producto.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1255399601 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-183440654\" 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 medicamentos veterinarios est\u00e1n cubiertos por las directrices de la EMA?<\/h4>\n\t<div id=\"gap-778188947\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-778188947 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda se aplica a <strong>todos los VMP,<\/strong> incluido <strong>biol\u00f3gicos, inmunol\u00f3gicos (vacunas), <\/strong>y<strong> Nuevas terapias. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-183440654 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1066554950\" 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>\u00bfLos medicamentos veterinarios inmunol\u00f3gicos est\u00e1n sujetos a los mismos requisitos?<\/h4>\n\t<div id=\"gap-235683886\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-235683886 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>S\u00ed. Se incluyen los VMP inmunol\u00f3gicos, pero la gu\u00eda proporciona una <strong>Enfoque de implementaci\u00f3n por fases y flexibilidad adicional<\/strong> debido a su perfil de bajo riesgo.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1066554950 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1357557468\" 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 empresas a cumplir con la gu\u00eda de impurezas elementales de la EMA?<\/h4>\n\t<div id=\"gap-419612852\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-419612852 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> ayuda a los equipos regulatorios y de calidad a rastrear las actualizaciones de las pautas de la EMA, evaluar su impacto en las carteras de productos veterinarios y administrar la evaluaci\u00f3n de riesgos y los requisitos de documentaci\u00f3n a trav\u00e9s de inteligencia regulatoria impulsada por IA y automatizaci\u00f3n del flujo de trabajo.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1357557468 > .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 February 20, 2026, the European Medicines Agency published final guidance setting out risk management requirements for elemental impurities in all veterinary medicinal products (VMPs), including biologicals, immunologicals such as vaccines, and novel therapies. The guidance applies to manufacturers responsible for the quality, safety, and regulatory compliance of veterinary pharmaceuticals used in animals.<\/p>","protected":false},"author":41,"featured_media":9535,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33,39],"tags":[],"class_list":["post-9534","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news","category-medical-devices-insights"],"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 Issues Final Elemental Impurity Guidance Released<\/title>\n<meta name=\"description\" content=\"Explore the EMA&#039;s final guidance on elemental impurity risk management for veterinary medicinal products and its impact on manufacturers.\" 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