{"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-1715098187\">\n\n\t<div id=\"col-1837561313\" 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-93001970\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-93001970 {\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-91774276\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-91774276 {\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-1837561313 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1360479804\" 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-1894199373\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1894199373 {\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-1360479804 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1397710971\" 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-1063228381\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1063228381 {\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-1397710971 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-494155607\" 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-476957469\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-476957469 {\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-494155607 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1359776954\" 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-428959396\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-428959396 {\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-1359776954 > .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-947369217\">\n\n\t<div id=\"col-700339365\" 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-2073292667\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2073292667 {\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-333222018\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-333222018 {\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-700339365 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-913932689\" 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-326794482\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-326794482 {\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-913932689 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-3702388\" 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-1394629276\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1394629276 {\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-3702388 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-474032567\" 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-36324602\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-36324602 {\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-474032567 > .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 24 de marzo de 2026, la Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA, por sus siglas en ingl\u00e9s) introdujo nuevos principios regulatorios para las solicitudes de comercializaci\u00f3n de medicamentos para uso humano que se basan en evidencia obtenida sin animales. Esta actualizaci\u00f3n respalda la estrategia general del Gobierno del Reino Unido para reducir y reemplazar las pruebas con animales y se aplica a todos los medicamentos que solicitan la autorizaci\u00f3n de comercializaci\u00f3n en el Reino Unido.<\/p>","protected":false},"author":43,"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 v28.6 (Yoast SEO v28.7) - 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 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