{"id":9628,"date":"2026-03-11T15:24:15","date_gmt":"2026-03-11T07:24:15","guid":{"rendered":"https:\/\/regask.com\/?p=9628"},"modified":"2026-03-11T15:24:15","modified_gmt":"2026-03-11T07:24:15","slug":"la-mhra-del-reino-unido-emite-una-guia-sobre-la-aprobacion-regulatoria-de-productos-farmaceuticos-fabricados-en-el-espacio","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-mhra-issues-guidance-on-regulatory-approval-for-space-manufactured-pharmaceuticals\/","title":{"rendered":"La MHRA del Reino Unido publica una gu\u00eda sobre la aprobaci\u00f3n regulatoria para\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">En\u00a0<\/span><b><span data-contrast=\"auto\">5 de marzo de 2026<\/span><\/b><span data-contrast=\"auto\">, La Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA), junto con la Agencia Espacial del Reino Unido, la Oficina de Innovaci\u00f3n Regulatoria (RIO) y la Autoridad de Aviaci\u00f3n Civil (CAA), anunciaron nuevas\u00a0<\/span><b><span data-contrast=\"auto\">Orientaci\u00f3n regulatoria para productos farmac\u00e9uticos fabricados en el espacio<\/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<p><span data-contrast=\"auto\">La iniciativa describe c\u00f3mo las empresas existentes\u00a0<\/span><b><span data-contrast=\"auto\">Marcos regulatorios de medicamentos y vuelos espaciales del Reino Unido<\/span><\/b><span data-contrast=\"auto\">\u00a0Puede aplicarse a medicamentos producidos en\u00a0<\/span><b><span data-contrast=\"auto\">entornos de microgravedad<\/span><\/b><span data-contrast=\"auto\">, en particular productos biol\u00f3gicos y otras terapias complejas. La gu\u00eda busca apoyar a las empresas que desarrollan la fabricaci\u00f3n de productos farmac\u00e9uticos en el espacio, a la vez que aclara las expectativas regulatorias para la aprobaci\u00f3n y el acceso al mercado en el Reino Unido.<\/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<div class=\"row\"  id=\"row-235090345\">\n\n\t<div id=\"col-1965130054\" 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-802491509\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-802491509 {\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-1880336078\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1880336078 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La gu\u00eda reci\u00e9n introducida explica c\u00f3mo\u00a0<\/span><b><span data-contrast=\"auto\">Las regulaciones existentes sobre medicamentos en el Reino Unido se aplican a los productos farmac\u00e9uticos fabricados en \u00f3rbita mediante plataformas de microgravedad.<\/span><\/b><span data-contrast=\"auto\">. El marco ayuda a las empresas a comprender las expectativas regulatorias para el desarrollo de productos, los est\u00e1ndares de fabricaci\u00f3n y la eventual autorizaci\u00f3n de comercializaci\u00f3n.<\/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\">Adem\u00e1s, los reguladores introducir\u00e1n un\u00a0<\/span><b><span data-contrast=\"auto\">Zona de pruebas regulatoria de reingreso<\/span><\/b><span data-contrast=\"auto\">, Dise\u00f1ado para apoyar a las empresas que prueban enfoques regulatorios para el retorno seguro a la Tierra de productos fabricados en el espacio. Este entorno de pruebas permite a los reguladores y a las partes interesadas de la industria evaluar las consideraciones operativas, de seguridad y de cumplimiento relacionadas con el reingreso y la manipulaci\u00f3n de productos.<\/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 a\u00fan m\u00e1s la comprensi\u00f3n de la industria, las agencias publicar\u00e1n\u00a0<\/span><b><span data-contrast=\"auto\">estudios de casos basados en principios<\/span><\/b><span data-contrast=\"auto\">\u00a0Demostraci\u00f3n de posibles v\u00edas regulatorias para la fabricaci\u00f3n de productos farmac\u00e9uticos en entornos espaciales. Estos ejemplos buscan ayudar a las organizaciones a evaluar c\u00f3mo las regulaciones existentes podr\u00edan aplicarse a diferentes escenarios de fabricaci\u00f3n en entornos de microgravedad.<\/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 iniciativa tambi\u00e9n pone \u00e9nfasis en\u00a0<\/span><b><span data-contrast=\"auto\">Compromiso temprano con los servicios de asesoramiento cient\u00edfico y regulatorio de la MHRA<\/span><\/b><span data-contrast=\"auto\">, alentando a las empresas a consultar a los reguladores durante la planificaci\u00f3n del desarrollo para comprender mejor los requisitos regulatorios aplicables.<\/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\">Por \u00faltimo, el programa destaca la importancia de\u00a0<\/span><b><span data-contrast=\"auto\">Fortalecimiento de la colaboraci\u00f3n en toda la cadena de suministro de tecnolog\u00eda farmac\u00e9utica y espacial<\/span><\/b><span data-contrast=\"auto\">, ayudando a facilitar la comercializaci\u00f3n a largo plazo de medicamentos fabricados en el espacio.<\/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-1965130054 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1093315733\" 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-304470956\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-304470956 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">Esta iniciativa regulatoria prev\u00e9:\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>Mayor claridad sobre c\u00f3mo se aplican las regulaciones existentes sobre medicamentos y vuelos espaciales del Reino Unido a los productos farmac\u00e9uticos producidos en entornos de microgravedad.<\/strong><\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>.<\/strong> Por\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">estableciendo<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0Orientaci\u00f3n, estudios de casos y un entorno regulatorio: el marco apoya la innovaci\u00f3n mientras\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">manteniendo<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0supervisi\u00f3n regulatoria. Tambi\u00e9n promueve<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">Alineaci\u00f3n regulatoria, mejor planificaci\u00f3n del desarrollo y v\u00edas eficientes para tecnolog\u00edas emergentes de ciencias de la vida basadas en el espacio<\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">.<\/span><\/span><span class=\"EOP SCXW10975365 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-1093315733 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-362259605\" 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-1305466735\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1305466735 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">La orientaci\u00f3n es especialmente relevante para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">fabricantes farmac\u00e9uticos, empresas de biotecnolog\u00eda y proveedores de plataformas de microgravedad<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0Explorando el desarrollo de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">productos biol\u00f3gicos, terapias avanzadas y otros medicamentos complejos<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0Eso puede\u00a0<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">beneficio<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0de entornos de fabricaci\u00f3n de microgravedad.<\/span><\/span><span class=\"EOP SCXW248171813 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-362259605 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1558374467\" 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-1415127228\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1415127228 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organizaciones involucradas en\u00a0<\/span><b><span data-contrast=\"auto\">Fabricaci\u00f3n farmac\u00e9utica basada en el espacio<\/span><\/b><span data-contrast=\"auto\">\u00a0Deber\u00eda revisarse los enfoques regulatorios delineados y evaluar si las iniciativas actuales o planificadas se alinean con el nuevo marco.<\/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\">Se anima a las empresas que desarrollan dichas tecnolog\u00edas a:\u00a0<\/span><b><span data-contrast=\"auto\">Interact\u00fae tempranamente con los servicios de asesoramiento cient\u00edfico y regulatorio de la MHRA<\/span><\/b><span data-contrast=\"auto\">\u00a0para comprender mejor las v\u00edas regulatorias aplicables, las consideraciones de desarrollo y los requisitos de cumplimiento.<\/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 los marcos regulatorios evolucionan para apoyar tecnolog\u00edas emergentes como la fabricaci\u00f3n basada en el espacio, los equipos regulatorios deben mantenerse a la vanguardia de las nuevas orientaciones y los desarrollos de pol\u00edticas intersectoriales.\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0es un l\u00edder\u00a0<\/span><b><span data-contrast=\"auto\">Plataforma de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de Agentic<\/span><\/b><span data-contrast=\"auto\">\u00a0que permite a las organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, navegar proactivamente en entornos regulatorios complejos. Al combinar tecnolog\u00eda avanzada\u00a0<\/span><b><span data-contrast=\"auto\">IA agente con expertos en el circuito<\/span><\/b><span data-contrast=\"auto\">,\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/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.\u00a0<\/span><b><span data-contrast=\"auto\"><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><\/span><\/b><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-1558374467 > .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-2132280801\">\n\n\t<div id=\"col-1943294218\" 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-1766662838\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1766662838 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW283686 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW283686 BCX0\">\u00bfCu\u00e1l es la orientaci\u00f3n de la MHRA sobre los medicamentos fabricados en el espacio?<\/span><\/span><span class=\"EOP SCXW283686 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-1788518481\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1788518481 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\">La gu\u00eda aclara c\u00f3mo se aplican los marcos regulatorios de medicamentos y vuelos espaciales existentes en el Reino Unido a los productos farmac\u00e9uticos producidos en\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\">entornos de microgravedad<\/span><\/span><\/strong><span class=\"TextRun SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\"><strong>,<\/strong> incluyendo el desarrollo, la participaci\u00f3n regulatoria y el regreso del producto a la Tierra.<\/span><\/span><span class=\"EOP SCXW68796879 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-1943294218 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-187533525\" 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 SCXW90362748 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW90362748 BCX0\">\u00bfQu\u00e9 es el Sandbox Regulatorio de Reingreso?<\/span><\/span><span class=\"EOP SCXW90362748 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-1920376107\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1920376107 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">El\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">Zona de pruebas regulatoria de reingreso<\/span><\/span><\/strong><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\"><strong>\u00a0<\/strong>es un entorno de pruebas regulatorias dise\u00f1ado para ayudar a las empresas a evaluar enfoques para regresar de manera segura<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">productos farmac\u00e9uticos fabricados en el espacio<\/span><\/span><\/strong><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">\u00a0De la \u00f3rbita a la Tierra.<\/span><\/span><span class=\"EOP SCXW250166262 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-187533525 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-165083503\" 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 SCXW14021316 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW14021316 BCX0\">\u00bfQu\u00e9 tipos de medicamentos son m\u00e1s relevantes para la fabricaci\u00f3n en microgravedad?<\/span><\/span><span class=\"EOP SCXW14021316 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-884547946\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-884547946 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW88875603 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88875603 BCX0\">La iniciativa destaca\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW88875603 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88875603 BCX0\">productos biol\u00f3gicos, terapias avanzadas y otros medicamentos complejos<\/span><\/span><\/strong><span class=\"TextRun SCXW88875603 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88875603 BCX0\">\u00a0como \u00e1reas que pueden\u00a0<\/span><span class=\"NormalTextRun SCXW88875603 BCX0\">beneficio<\/span><span class=\"NormalTextRun SCXW88875603 BCX0\">\u00a0a partir de procesos de fabricaci\u00f3n realizados en entornos de microgravedad.<\/span><\/span><span class=\"EOP SCXW88875603 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-165083503 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1999458622\" 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 monitorear las actualizaciones regulatorias relacionadas con las f\u00f3rmulas infantiles?<\/h4>\n\t<div id=\"gap-1527353369\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1527353369 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW88416556 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW88416556 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW88416556 BCX0\">\u00a0ayuda a los equipos regulatorios y de cumplimiento\u00a0<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">\u00a0evolucionar las regulaciones globales, evaluar el impacto regulatorio y gestionar los flujos de trabajo de cumplimiento en todo el mundo.\u00a0<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">jurisdicciones<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">, permitiendo a las organizaciones mantenerse informadas y preparadas como\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW88416556 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88416556 BCX0\">Nuevas v\u00edas regulatorias para tecnolog\u00edas emergentes<\/span><\/span><\/strong><span class=\"TextRun SCXW88416556 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88416556 BCX0\">\u00a0se introducen.<\/span><\/span><span class=\"EOP SCXW88416556 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-1999458622 > .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 5 de marzo de 2026, la Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA), junto con la Agencia Espacial del Reino Unido, la Oficina de Innovaci\u00f3n Regulatoria (RIO) y la Autoridad de Aviaci\u00f3n Civil (CAA), anunciaron nuevas directrices regulatorias para productos farmac\u00e9uticos fabricados en el espacio. La iniciativa describe c\u00f3mo los marcos regulatorios vigentes del Reino Unido para medicamentos y vuelos espaciales pueden aplicarse a los medicamentos producidos en entornos de microgravedad, en particular los productos biol\u00f3gicos y\u2026<\/p>","protected":false},"author":43,"featured_media":9629,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9628","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 v28.5 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Issues Guidance on Regulatory Approval<\/title>\n<meta name=\"description\" content=\"Explore the UK MHRA guidance 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