{"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-1814737751\">\n\n\t<div id=\"col-1854975806\" 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-1885906833\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1885906833 {\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-1976232705\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1976232705 {\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-1854975806 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1258267170\" 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-528019247\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-528019247 {\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-1258267170 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-354111672\" 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-1943132905\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1943132905 {\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-354111672 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-22336015\" 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-372610195\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-372610195 {\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-22336015 > .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-188680260\">\n\n\t<div id=\"col-1597491516\" 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-338096009\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-338096009 {\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-2003048486\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2003048486 {\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-1597491516 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1086684747\" 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-1730290331\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1730290331 {\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-1086684747 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1228916988\" 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-1513610482\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1513610482 {\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-1228916988 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1414857714\" 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-703708640\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-703708640 {\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-1414857714 > .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\u00a0March 5, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA), together with the UK Space Agency, the Regulatory Innovation Office (RIO), and the Civil Aviation Authority (CAA), announced new\u00a0regulatory guidance for pharmaceuticals manufactured in space.\u00a0 The initiative outlines how existing\u00a0UK medicines and spaceflight regulatory frameworks\u00a0may apply to medicines produced in\u00a0microgravity environments, particularly biologics and&#8230;<\/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 v27.7 (Yoast SEO v27.8) - 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 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