{"id":9748,"date":"2026-04-01T11:48:47","date_gmt":"2026-04-01T03:48:47","guid":{"rendered":"https:\/\/regask.com\/?p=9748"},"modified":"2026-04-01T15:51:32","modified_gmt":"2026-04-01T07:51:32","slug":"la-mhra-del-reino-unido-establece-una-via-regulatoria-para-eliminar-gradualmente-las-pruebas-con-animales-en-el-desarrollo-de-farmacos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/","title":{"rendered":"La MHRA del Reino Unido establece una v\u00eda regulatoria para eliminar gradualmente las pruebas en animales\u2026"},"content":{"rendered":"<p>El 24 de marzo de 2026, el <strong>Agencia Reguladora de Medicamentos y Productos Sanitarios<\/strong> (MHRA) introdujo nuevos principios regulatorios para <strong>aplicaciones de comercializaci\u00f3n de medicamentos para uso humano<\/strong> que dependen de <strong>evidencia no animal.<\/strong> Esta actualizaci\u00f3n respalda la estrategia m\u00e1s amplia del Gobierno del Reino Unido para reducir y reemplazar las pruebas con animales y se aplica a todos los medicamentos que buscan <strong>Autorizaci\u00f3n de comercializaci\u00f3n (AC)<\/strong> en el Reino Unido.<\/p>\n<div class=\"row\"  id=\"row-656972363\">\n\n\t<div id=\"col-995612725\" 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-1086354672\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1086354672 {\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-2000181955\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2000181955 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La MHRA ha establecido\u00a0<\/span><b><span data-contrast=\"auto\">cinco principios regulatorios<\/span><\/b><span data-contrast=\"auto\">\u00a0Definir cu\u00e1ndo las pruebas con animales son obligatorias, opcionales o pueden omitirse.\u00a0<\/span><b><span data-contrast=\"auto\">Productos gen\u00e9ricos, biosimilares y farmacol\u00f3gicamente inactivos<\/span><\/b><span data-contrast=\"auto\">\u00a0no deber\u00eda someterse a pruebas con animales, mientras que\u00a0<\/span><b><span data-contrast=\"auto\">Pruebas de toxicidad para productos biol\u00f3gicos<\/span><\/b><span data-contrast=\"auto\">\u00a0debe limitarse a especies farmacol\u00f3gicamente relevantes. La agencia tambi\u00e9n permite\u00a0<\/span><b><span data-contrast=\"auto\">productos con perfiles farmacol\u00f3gicos bien conocidos<\/span><\/b><span data-contrast=\"auto\">\u00a0entrar en ensayos cl\u00ednicos en el Reino Unido sin estudios previos en animales. Sin embargo,\u00a0<\/span><b><span data-contrast=\"auto\">productos con mecanismos farmacol\u00f3gicos novedosos<\/span><\/b><span data-contrast=\"auto\">\u00a0A\u00fan debe cumplir con los requisitos internacionales de experimentaci\u00f3n con animales. Adem\u00e1s,\u00a0<\/span><b><span data-contrast=\"auto\">vacunas para enfermedades infecciosas pand\u00e9micas emergentes<\/span><\/b><span data-contrast=\"auto\">, Cuando no se puede evaluar la eficacia en ensayos cl\u00ednicos, se debe seguir recurriendo a las pruebas con animales.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Para apoyar la adopci\u00f3n de\u00a0<\/span><b><span data-contrast=\"auto\">Nuevas Metodolog\u00edas de Enfoque (NAM, por sus siglas en ingl\u00e9s)<\/span><\/b><span data-contrast=\"auto\">, incluyendo modelos derivados por humanos y an\u00e1lisis impulsados por IA, la MHRA presentar\u00e1 una\u00a0<\/span><b><span data-contrast=\"auto\">Plan de revisi\u00f3n anticipada para el M\u00f3dulo 4<\/span><\/b><span data-contrast=\"auto\">\u00a0para finales de 2026. Esto permite a las empresas que desarrollan productos sin pruebas en animales presentar\u00a0<\/span><b><span data-contrast=\"auto\">M\u00f3dulo 4<\/span><\/b><span data-contrast=\"auto\">, el\u00a0<\/span><b><span data-contrast=\"auto\">Folleto del investigador<\/span><\/b><span data-contrast=\"auto\">, y al menos un informe de ensayo cl\u00ednico para evaluaci\u00f3n temprana. La agencia proporcionar\u00e1 un\u00a0<\/span><b><span data-contrast=\"auto\">opini\u00f3n escrita no vinculante<\/span><\/b><span data-contrast=\"auto\">\u00a0sobre la adecuaci\u00f3n de los datos, que pueden incluirse en la solicitud de autorizaci\u00f3n de comercializaci\u00f3n final.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La MHRA llevar\u00e1 a cabo una revisi\u00f3n posterior en consulta con la\u00a0<\/span><b><span data-contrast=\"auto\">Comisi\u00f3n de Medicamentos para Uso Humano<\/span><\/b><span data-contrast=\"auto\">, decidiendo en \u00faltima instancia si aprueba o rechaza la solicitud, proporcionando las razones de cualquier rechazo.\u00a0<\/span><b><span data-contrast=\"auto\">tarifa de recuperaci\u00f3n de costos<\/span><\/b><span data-contrast=\"auto\">\u00a0Se aplicar\u00e1 una tarifa a las presentaciones anticipadas para desalentar las solicitudes inadecuadas, aunque no se ha especificado la tarifa exacta.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Es importante tener en cuenta que este proceso de revisi\u00f3n anticipada se aplica \u00fanicamente a\u00a0<\/span><b><span data-contrast=\"auto\">Solicitudes de autorizaci\u00f3n de comercializaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0y no afecta\u00a0<\/span><b><span data-contrast=\"auto\">Autorizaci\u00f3n de ensayos cl\u00ednicos<\/span><\/b><span data-contrast=\"auto\">\u00a0procedimientos.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>Esta iniciativa se alinea con la estrategia del Gobierno del Reino Unido de noviembre de 2025, <strong>\u201cSustituir a los animales en la ciencia: una estrategia para apoyar el desarrollo, la validaci\u00f3n y la adopci\u00f3n de m\u00e9todos alternativos.\u201d<\/strong> Refuerza el cambio regulatorio hacia <strong>marcos de referencia para pruebas sin animales<\/strong> en el desarrollo de f\u00e1rmacos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-995612725 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-743103552\" 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>Cronogramas<\/h2>\n\t<div id=\"gap-2123808269\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2123808269 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El <strong>Plan de revisi\u00f3n del M\u00f3dulo 4<\/strong> Se espera que entre en funcionamiento para el <strong>finales de 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-743103552 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1747632854\" 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-1898520255\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1898520255 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n proporciona <strong>Orientaci\u00f3n regulatoria clara<\/strong> sobre el uso de evidencia no animal, lo que permite una mayor<strong> certeza regulatoria<\/strong> para las empresas farmac\u00e9uticas y biotecnol\u00f3gicas. Al formalizar las condiciones bajo las cuales se pueden reducir o evitar las pruebas con animales, la MHRA apoya <strong>innovaci\u00f3n digital y cient\u00edfica<\/strong>, incluidas las metodolog\u00edas basadas en IA. La introducci\u00f3n de un mecanismo de revisi\u00f3n anticipada puede mejorar<strong> eficiencia del desarrollo<\/strong> y reducir los riesgos probatorios, manteniendo al mismo tiempo el rigor regulatorio y minimizando las cargas innecesarias.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1747632854 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1602678797\" 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-877995004\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-877995004 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">Esta actualizaci\u00f3n es relevante para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">equipos de asuntos regulatorios, investigaci\u00f3n y desarrollo, garant\u00eda de calidad y finanzas<\/span><\/span><\/strong><span class=\"TextRun SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">\u00a0dentro de las organizaciones farmac\u00e9uticas y biotecnol\u00f3gicas. Las partes interesadas deben evaluar c\u00f3mo se aplican los nuevos principios a sus carteras de productos,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW120779043 BCX0\">particularmente para<\/span><span class=\"NormalTextRun SCXW120779043 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">productos biol\u00f3gicos, gen\u00e9ricos, biosimilares y terapias novedosas<\/span><\/span><\/strong><span class=\"TextRun SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\"><strong>,<\/strong> y garantizar la preparaci\u00f3n para el cumplimiento de las expectativas de la MHRA.<\/span><\/span><span class=\"EOP SCXW120779043 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1602678797 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1445220062\" 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-87201948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-87201948 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deben revisar la gu\u00eda completa de la MHRA para determinar c\u00f3mo\u00a0<\/span><b><span data-contrast=\"auto\">cinco principios regulatorios<\/span><\/b><span data-contrast=\"auto\">\u00a0aplicar a sus productos y evaluar el valor estrat\u00e9gico de los mismos.\u00a0<\/span><b><span data-contrast=\"auto\">Esquema de presentaci\u00f3n anticipada del M\u00f3dulo 4<\/span><\/b><span data-contrast=\"auto\">\u00a0antes de su implementaci\u00f3n. Los equipos tambi\u00e9n deben evaluar la adecuaci\u00f3n de\u00a0<\/span><b><span data-contrast=\"auto\">paquetes de datos no animales<\/span><\/b><span data-contrast=\"auto\">, alinear los dise\u00f1os de estudios no cl\u00ednicos con el marco actualizado y tener en cuenta los posibles\u00a0<\/span><b><span data-contrast=\"auto\">tarifas de recuperaci\u00f3n de costos<\/span><\/b><span data-contrast=\"auto\">\u00a0en la planificaci\u00f3n del desarrollo.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A medida que las expectativas regulatorias evolucionan hacia\u00a0<\/span><b><span data-contrast=\"auto\">Metodolog\u00edas sin animales y evidencia respaldada por IA<\/span><\/b><span data-contrast=\"auto\">, mantenerse a la vanguardia de los cambios globales se vuelve fundamental. RegASK es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA de agentes que empodera a las organizaciones globales en sectores altamente regulados, incluidos los productos de consumo y las ciencias de la vida, para navegar de manera proactiva por entornos regulatorios complejos. Al combinar IA de agentes avanzada con expertos en el proceso, <a href=\"http:\/\/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. <strong><a href=\"http:\/\/regask.com\/es\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reserve una demostraci\u00f3n ahora.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1445220062 > .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-1495357241\">\n\n\t<div id=\"col-232674084\" 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-560904549\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-560904549 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW126598592 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW126598592 BCX0\">\u00bfQu\u00e9 son las Metodolog\u00edas de Nuevo Enfoque (MNE) en el desarrollo de f\u00e1rmacos?<\/span><\/span><span class=\"EOP SCXW126598592 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-289970379\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-289970379 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW29844584 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW29844584 BCX0\">Los NAM son<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW29844584 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW29844584 BCX0\">m\u00e9todos cient\u00edficos sin animales<\/span><\/span><\/strong><span class=\"TextRun SCXW29844584 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW29844584 BCX0\"><strong>,<\/strong> incluyendo modelos de c\u00e9lulas derivadas de humanos y an\u00e1lisis basados en inteligencia artificial, utilizados para generar evidencia para el desarrollo de f\u00e1rmacos.<\/span><\/span><span class=\"EOP SCXW29844584 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-232674084 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1239573622\" 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><span class=\"TextRun MacChromeBold SCXW128671175 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW128671175 BCX0\">\u00bfQu\u00e9 es el M\u00f3dulo 4 en Marketing?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW128671175 BCX0\">Autorizaci\u00f3n<\/span><span class=\"NormalTextRun SCXW128671175 BCX0\">\u00a0\u00bfsolicitud?<\/span><\/span><span class=\"EOP SCXW128671175 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-179018006\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-179018006 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><span class=\"TextRun MacChromeBold SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\">M\u00f3dulo 4 <\/span><\/span><\/strong><span class=\"TextRun SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\">contiene <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\">informes de estudios no cl\u00ednicos<\/span><\/span><\/strong><span class=\"TextRun SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\"><strong>,<\/strong> incluyendo datos farmacol\u00f3gicos y toxicol\u00f3gicos, utilizados para respaldar la seguridad de un medicamento.<\/span><\/span><span class=\"EOP SCXW40790795 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1239573622 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-642651232\" 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><span class=\"TextRun MacChromeBold SCXW106275594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW106275594 BCX0\">\u00bfCu\u00e1ndo entrar\u00e1 en vigor el plan de revisi\u00f3n del M\u00f3dulo 4 avanzado de la MHRA?<\/span><\/span><span class=\"EOP SCXW106275594 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-2091221889\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2091221889 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW170672751 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW170672751 BCX0\">Se espera que el plan est\u00e9 operativo para el\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW170672751 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW170672751 BCX0\">fin de\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW170672751 BCX0\">2026<\/span><\/span><span class=\"TextRun SCXW170672751 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW170672751 BCX0\">.<\/span><\/span><span class=\"EOP SCXW170672751 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-642651232 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1019711647\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0ayuda a las organizaciones\u00a0<\/span><b><span data-contrast=\"auto\">monitorear los requisitos regulatorios en constante evoluci\u00f3n<\/span><\/b><span data-contrast=\"auto\">, evaluar\u00a0<\/span><b><span data-contrast=\"auto\">Preparaci\u00f3n de datos para env\u00edos sin animales<\/span><\/b><span data-contrast=\"auto\">, y simplificar\u00a0<\/span><b><span data-contrast=\"auto\">flujos de trabajo de cumplimiento de principio a fin<\/span><\/b><span data-contrast=\"auto\">, lo que permite una adopci\u00f3n m\u00e1s eficiente de los NAM en l\u00ednea con las expectativas de la MHRA.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-621077845\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-621077845 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">RegASK ayuda a las organizaciones\u00a0<\/span><b><span data-contrast=\"auto\">Realizar un seguimiento de los cambios regulatorios, evaluar su impacto y coordinar las actualizaciones interfuncionales.<\/span><\/b><span data-contrast=\"auto\">, lo que permite un cumplimiento eficiente de los requisitos en constante evoluci\u00f3n, como por ejemplo:\u00a0<\/span><b><span data-contrast=\"auto\">Actualizaciones del empaquetado, revisiones del prospecto informativo e implementaci\u00f3n del folleto digital.<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1019711647 > .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 24, 2026, the Medicines &amp; Healthcare products Regulatory Agency (MHRA) introduced new regulatory principles for human medicines marketing applications that rely on non-animal evidence. This update supports the UK Government\u2019s broader strategy to reduce and replace animal testing and applies to all medicines seeking Marketing Authorisation (MA) in the United Kingdom.<\/p>","protected":false},"author":41,"featured_media":9761,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9748","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-pharma-biotech-latest-insights"],"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>UK MHRA Sets Regulatory Pathway for Drug Testing<\/title>\n<meta name=\"description\" content=\"UK MHRA sets a new regulatory pathway to phase out animal testing in drug development, promoting non-animal evidence.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/la-mhra-del-reino-unido-establece-una-via-regulatoria-para-eliminar-gradualmente-las-pruebas-con-animales-en-el-desarrollo-de-farmacos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK MHRA Sets Regulatory Pathway to Phase Out Animal Testing in Drug Development\" \/>\n<meta property=\"og:description\" content=\"UK MHRA sets a new regulatory pathway to phase out animal testing in drug development, promoting non-animal evidence.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/la-mhra-del-reino-unido-establece-una-via-regulatoria-para-eliminar-gradualmente-las-pruebas-con-animales-en-el-desarrollo-de-farmacos\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-01T03:48:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-01T07:51:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\"},\"headline\":\"UK MHRA Sets Regulatory Pathway to Phase Out Animal Tes&hellip;\",\"datePublished\":\"2026-04-01T03:48:47+00:00\",\"dateModified\":\"2026-04-01T07:51:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/\"},\"wordCount\":933,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png\",\"articleSection\":[\"Regulatory News\",\"United Kingdom\",\"Pharma and Biotech\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/\",\"name\":\"UK MHRA Sets Regulatory Pathway for Drug Testing\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png\",\"datePublished\":\"2026-04-01T03:48:47+00:00\",\"dateModified\":\"2026-04-01T07:51:32+00:00\",\"description\":\"UK MHRA sets a new regulatory pathway to phase out animal testing in drug development, promoting non-animal evidence.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png\",\"width\":800,\"height\":600,\"caption\":\"Uk Mhra Sets Regulatory Pathway To Phase Out Animal Testing In Drug Development\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\",\"name\":\"Shaffa Renaningtyas\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"La MHRA del Reino Unido establece la v\u00eda regulatoria para las pruebas de detecci\u00f3n de drogas.","description":"La MHRA del Reino Unido establece una nueva v\u00eda regulatoria para eliminar gradualmente las pruebas con animales en el desarrollo de f\u00e1rmacos, promoviendo la obtenci\u00f3n de evidencia sin animales.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/la-mhra-del-reino-unido-establece-una-via-regulatoria-para-eliminar-gradualmente-las-pruebas-con-animales-en-el-desarrollo-de-farmacos\/","og_locale":"es_ES","og_type":"article","og_title":"UK MHRA Sets Regulatory Pathway to Phase Out Animal Testing in Drug Development","og_description":"UK MHRA sets a new regulatory pathway to phase out animal testing in drug development, promoting non-animal evidence.","og_url":"https:\/\/regask.com\/es\/la-mhra-del-reino-unido-establece-una-via-regulatoria-para-eliminar-gradualmente-las-pruebas-con-animales-en-el-desarrollo-de-farmacos\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-04-01T03:48:47+00:00","article_modified_time":"2026-04-01T07:51:32+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png","type":"image\/png"}],"author":"Shaffa Renaningtyas","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Shaffa Renaningtyas","Est. reading time":"5 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/#article","isPartOf":{"@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/"},"author":{"name":"Shaffa Renaningtyas","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6"},"headline":"UK MHRA Sets Regulatory Pathway to Phase Out Animal Tes&hellip;","datePublished":"2026-04-01T03:48:47+00:00","dateModified":"2026-04-01T07:51:32+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/"},"wordCount":933,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png","articleSection":["Regulatory News","United Kingdom","Pharma and Biotech"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/","url":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/","name":"La MHRA del Reino Unido establece la v\u00eda regulatoria para las pruebas de detecci\u00f3n de drogas.","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png","datePublished":"2026-04-01T03:48:47+00:00","dateModified":"2026-04-01T07:51:32+00:00","description":"La MHRA del Reino Unido establece una nueva v\u00eda regulatoria para eliminar gradualmente las pruebas con animales en el desarrollo de f\u00e1rmacos, promoviendo la obtenci\u00f3n de evidencia sin animales.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development.png","width":800,"height":600,"caption":"Uk Mhra Sets Regulatory Pathway To Phase Out Animal Testing In Drug Development"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Habilitando decisiones regulatorias m\u00e1s inteligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6","name":"Shaffa Renaningtyas"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9748","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=9748"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9748\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/9761"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=9748"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=9748"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=9748"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}