{"id":9716,"date":"2026-03-25T17:04:10","date_gmt":"2026-03-25T09:04:10","guid":{"rendered":"https:\/\/regask.com\/?p=9716"},"modified":"2026-03-25T17:04:56","modified_gmt":"2026-03-25T09:04:56","slug":"mhra-y-nice-lanzan-un-proceso-de-concesion-de-licencias-y-evaluacion-de-tecnologias-sanitarias-ets-armonizado-para-acelerar-el-acceso-a-los-medicamentos-en-inglaterra","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/mhra-and-nice-launch-aligned-licensing-and-hta-process-to-accelerate-access-to-medicines-in-england\/","title":{"rendered":"La MHRA y el NICE lanzan un proceso armonizado de concesi\u00f3n de licencias y evaluaci\u00f3n de tecnolog\u00edas sanitarias\u2026"},"content":{"rendered":"<p>En <strong>17 de marzo de 2026<\/strong>, el <strong>Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA)<\/strong> y el <strong>Instituto Nacional para la Excelencia en la Salud y la Atenci\u00f3n (NICE)<\/strong> anunci\u00f3 un nuevo <strong>proceso conjunto<\/strong> que se alinea <strong>licencias regulatorias<\/strong> con <strong>evaluaci\u00f3n de tecnolog\u00edas sanitarias (ETS)<\/strong> para productos farmac\u00e9uticos en Inglaterra. Lanzamiento el <strong>1 de abril de 2026<\/strong>, Este enfoque est\u00e1 dise\u00f1ado para <strong>acelerar el acceso de los pacientes a nuevos medicamentos entre tres y seis meses<\/strong> a trav\u00e9s de v\u00edas de revisi\u00f3n sincronizadas.<\/p>\n<div class=\"row\"  id=\"row-1320063558\">\n\n\t<div id=\"col-1096159718\" 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-789581268\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-789581268 {\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-133006126\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-133006126 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El nuevo proceso introduce una <strong>modelo de revisi\u00f3n paralela<\/strong>, lo que permite <strong>Decisiones de concesi\u00f3n de licencias de la MHRA<\/strong> y <strong>Evaluaciones de tecnolog\u00edas sanitarias del NICE<\/strong> Este proceso se llevar\u00e1 a cabo simult\u00e1neamente para los nuevos medicamentos. Se espera que este enfoque coordinado reduzca las demoras entre la aprobaci\u00f3n regulatoria y las decisiones de reembolso.<\/p>\n<p>Un componente clave de la iniciativa es el <strong>Servicio integrado de asesoramiento cient\u00edfico<\/strong>, que proporciona una <strong>punto de entrada \u00fanico<\/strong> para que las compa\u00f1\u00edas farmac\u00e9uticas reciban <strong>orientaci\u00f3n coordinada<\/strong> sobre requisitos regulatorios y generaci\u00f3n de evidencia. Esto tiene como objetivo garantizar la coherencia entre las estrategias de desarrollo cl\u00ednico y las expectativas regulatorias y de evaluaci\u00f3n de valor.<\/p>\n<p>El proceso se aplica espec\u00edficamente a <strong>Productos farmac\u00e9uticos que buscan entrar en el mercado de Inglaterra<\/strong>, mientras <strong>Los dispositivos m\u00e9dicos no est\u00e1n incluidos.<\/strong> en este lanzamiento inicial. La participaci\u00f3n comenzar\u00e1 bajo un <strong>fase de acceso temprano<\/strong>, con el <strong>Se prev\u00e9 que los primeros resultados se obtengan a partir de junio de 2026.<\/strong> para productos que se encuentran actualmente en desarrollo o en proceso de revisi\u00f3n.<\/p>\n<p>Las partes interesadas pueden acceder a m\u00e1s detalles a trav\u00e9s de un <strong>Seminario web exclusivo programado para el 25 de marzo de 2026.<\/strong>, lo que proporciona mayor claridad sobre la implementaci\u00f3n y las consideraciones operativas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1096159718 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-566513375\" 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 de entrada en vigor<\/h2>\n\t<div id=\"gap-435093213\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-435093213 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El proceso MHRA-NICE alineado se implementar\u00e1 a partir de <strong>1 de abril de 2026<\/strong>, con resultados iniciales previstos de <strong>Junio de 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-566513375 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1829992277\" 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-1717057400\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1717057400 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n mejora <strong>eficiencia regulatoria<\/strong> mediante la armonizaci\u00f3n de los procesos de concesi\u00f3n de licencias y reembolsos, la reducci\u00f3n de la duplicaci\u00f3n y la mejora de la coordinaci\u00f3n entre las autoridades. Apoya <strong>plazos de toma de decisiones m\u00e1s r\u00e1pidos<\/strong> y promueve <strong>alineaci\u00f3n de evidencia<\/strong> en todos los requisitos regulatorios y de HTA, facilitando en \u00faltima instancia <strong>acceso m\u00e1s r\u00e1pido para los pacientes<\/strong> al tiempo que se mantienen unos est\u00e1ndares de evaluaci\u00f3n rigurosos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1829992277 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1613333794\" 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-280409079\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-280409079 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Este desarrollo es relevante para <strong>Asuntos regulatorios<\/strong>, <strong>I+D<\/strong>, <strong>Acceso al mercado<\/strong>, y <strong>Equipos de Econom\u00eda de la Salud<\/strong> dentro de las compa\u00f1\u00edas farmac\u00e9uticas en desarrollo <strong>nuevos medicamentos para el mercado del Reino Unido<\/strong>, en particular aquellas solicitudes de planificaci\u00f3n presentadas en Inglaterra bajo marcos regulatorios y de reembolso en constante evoluci\u00f3n.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1613333794 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2052753294\" 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-1264348052\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1264348052 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deber\u00edan <strong>evaluar la cartera de productos actual<\/strong> para determinar la elegibilidad para el proceso alineado y considerar la participaci\u00f3n en el <strong>Seminario web del 25 de marzo<\/strong> para comprender los requisitos operativos. Interno <strong>estrategias de presentaci\u00f3n, planes de generaci\u00f3n de pruebas y procesos de preparaci\u00f3n de expedientes<\/strong> debe revisarse y actualizarse para alinearse con el <strong>Gu\u00eda integrada MHRA-NICE<\/strong>.<\/p>\n<p>A medida que los procesos regulatorios y de acceso al mercado se interconectan cada vez m\u00e1s, alinear la estrategia en ambos \u00e1mbitos es esencial para obtener aprobaciones y reembolsos oportunos.<\/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-2052753294 > .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-2017890748\">\n\n\t<div id=\"col-361342639\" 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-476836647\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-476836647 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfEn qu\u00e9 consiste el proceso alineado con la MHRA y el NICE?<\/h4>\n\t<div id=\"gap-1254538286\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1254538286 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es un <strong>v\u00eda conjunta de regulaci\u00f3n y evaluaci\u00f3n de tecnolog\u00edas sanitarias<\/strong> que permite <strong>Revisi\u00f3n paralela de las licencias y las evaluaciones de tecnolog\u00edas sanitarias.<\/strong> para nuevos medicamentos en Inglaterra.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-361342639 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-23652722\" 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 entrar\u00e1 en vigor el nuevo proceso?<\/h4>\n\t<div id=\"gap-1921673593\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1921673593 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El proceso se implementar\u00e1 a partir de <strong>1 de abril de 2026<\/strong>, con los primeros resultados previstos de <strong>Junio de 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-23652722 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1193789750\" 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 es el servicio de Asesoramiento Cient\u00edfico Integrado?<\/h4>\n\t<div id=\"gap-349464401\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-349464401 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es un <strong>punto de entrada \u00fanico<\/strong> que proporciona <strong>Orientaci\u00f3n coordinada sobre regulaci\u00f3n y evidencia<\/strong> para respaldar las presentaciones coordinadas a la MHRA y al NICE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1193789750 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-814854614\" 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 en el marco de este nuevo proceso?<\/h4>\n\t<div id=\"gap-673631595\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-673631595 {\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 las novedades regulatorias y de evaluaci\u00f3n de tecnolog\u00edas sanitarias.<\/strong>, alinear <strong>Estrategias de evidencia y presentaci\u00f3n<\/strong>, y simplificar <strong>flujos de trabajo interfuncionales<\/strong>, lo que permite una navegaci\u00f3n m\u00e1s eficiente por las v\u00edas de aprobaci\u00f3n sincronizadas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-814854614 > .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 17, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced a new joint process that aligns regulatory licensing with health technology assessment (HTA) for pharmaceuticals in England. Launching on April 1, 2026, this approach is designed to accelerate patient access to new&#8230;<\/p>","protected":false},"author":32,"featured_media":9717,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39,35],"tags":[],"class_list":["post-9716","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MHRA and NICE Launch Aligned Process for Medicines<\/title>\n<meta name=\"description\" content=\"Discover how the MHRA and NICE aligned licensing and HTA process will transform patient access to new medicines in England.\" \/>\n<meta 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