{"id":78483,"date":"2026-06-17T17:22:28","date_gmt":"2026-06-17T23:22:28","guid":{"rendered":"https:\/\/www.bbmnoticias.com\/labravaradiofm\/2026\/06\/17\/cofepris-implementa-via-abreviada-para-el-registro-sanitario-de-insumos-de-salud-en-mexico\/"},"modified":"2026-06-17T17:22:31","modified_gmt":"2026-06-17T23:22:31","slug":"cofepris-implementa-via-abreviada-para-el-registro-sanitario-de-insumos-de-salud-en-mexico","status":"publish","type":"post","link":"https:\/\/www.bbmnoticias.com\/labravaradiofm\/2026\/06\/17\/cofepris-implementa-via-abreviada-para-el-registro-sanitario-de-insumos-de-salud-en-mexico\/","title":{"rendered":"Cofepris implementa v\u00eda abreviada para el registro sanitario de insumos de salud en M\u00e9xico"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>\n<p>La Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) implement\u00f3 la v\u00eda regulatoria abreviada para la emisi\u00f3n de registros sanitarios de insumos de salud en M\u00e9xico.&nbsp;<\/p>\n\n\n\n<p>Esta estrategia deroga las disposiciones anteriores y establece un plazo m\u00e1ximo de resoluci\u00f3n de cuarenta y cinco d\u00edas h\u00e1biles para las solicitudes correspondientes, optimizando los tiempos operativos.<\/p>\n\n\n\n<p>El nuevo modelo se fundamenta en un esquema de equivalencias, a trav\u00e9s del cual la autoridad mexicana valida los criterios de evaluaci\u00f3n y los requisitos solicitados por agencias sanitarias internacionales de referencia o por la Organizaci\u00f3n Mundial de la Salud.&nbsp;<\/p>\n\n\n\n<p>El mecanismo se aplica a medicamentos nuevos farmoqu\u00edmicos, biol\u00f3gicos, biotecnol\u00f3gicos, vacunas, gen\u00e9ricos y biocomparables. Los lineamientos determinan que el expediente t\u00e9cnico debe presentarse en formato de Documento T\u00e9cnico Com\u00fan y estar integrado por cinco m\u00f3dulos que abarcan desde los datos administrativos hasta la evidencia cl\u00ednica.<\/p>\n\n\n\n<p>Para acceder a este beneficio, el insumo debe poseer una autorizaci\u00f3n sanitaria ordinaria vigente, expedida en un periodo no mayor a cinco a\u00f1os por la agencia de origen, y demostrar que sus caracter\u00edsticas b\u00e1sicas esenciales son id\u00e9nticas a las del producto que fue avalado en el extranjero.&nbsp;<\/p>\n\n\n\n<p>La evaluaci\u00f3n t\u00e9cnica que realiza el organismo de salud se compone de cuatro fases secuenciales que abarcan la asignaci\u00f3n, la verificaci\u00f3n abreviada, la revisi\u00f3n y la emisi\u00f3n de la resoluci\u00f3n definitiva. Durante la etapa de dictamen, se realiza una comparaci\u00f3n detallada de la informaci\u00f3n t\u00e9cnica frente a la autorizaci\u00f3n de la agencia externa para garantizar la concordancia en materias primas y seguridad cl\u00ednica.<\/p>\n\n\n\n<p>De acuerdo con las especificaciones de la autoridad, el incumplimiento a las disposiciones de este esquema abreviado o la falta de consistencia documental derivar\u00e1 en una negativa directa del registro sanitario solicitado.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) implement\u00f3 la v\u00eda regulatoria abreviada para la emisi\u00f3n de registros sanitarios de insumos de salud en M\u00e9xico.&nbsp; Esta estrategia deroga las disposiciones anteriores y establece un plazo m\u00e1ximo de resoluci\u00f3n de cuarenta y cinco d\u00edas h\u00e1biles para las solicitudes correspondientes, optimizando los tiempos operativos. El [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":78485,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,19],"tags":[],"class_list":{"0":"post-78483","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-oaxaca","8":"category-nacional"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cofepris implementa v\u00eda abreviada para el registro sanitario de insumos de salud en M\u00e9xico - LA BRAVA RADIO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bbmnoticias.com\/cofepris-implementa-via-abreviada-para-el-registro-sanitario-de-insumos-de-salud-en-mexico\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cofepris implementa v\u00eda abreviada para el registro sanitario de insumos de salud en M\u00e9xico - LA BRAVA RADIO\" \/>\n<meta property=\"og:description\" content=\"La Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) implement\u00f3 la v\u00eda regulatoria abreviada para la emisi\u00f3n de registros sanitarios de insumos de salud en M\u00e9xico.&nbsp; Esta estrategia deroga las disposiciones anteriores y establece un plazo m\u00e1ximo de resoluci\u00f3n de cuarenta y cinco d\u00edas h\u00e1biles para las solicitudes correspondientes, optimizando los tiempos operativos. 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