{"id":46627,"date":"2025-03-23T14:16:06","date_gmt":"2025-03-23T20:16:06","guid":{"rendered":"https:\/\/informante.mx\/?p=46627"},"modified":"2025-03-23T14:16:09","modified_gmt":"2025-03-23T20:16:09","slug":"mexico-refuerza-regulacion-sanitaria-con-nuevos-lineamientos","status":"publish","type":"post","link":"https:\/\/informante.mx\/?p=46627","title":{"rendered":"M\u00e9xico refuerza regulaci\u00f3n sanitaria con nuevos lineamientos"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">La actualizaci\u00f3n busca garantizar est\u00e1ndares internacionales de calidad, seguridad y eficacia en los insumos para la salud.<\/h2>\n\n\n\n<p><strong>Redacci\u00f3n Informante<\/strong><\/p>\n\n\n\n<p>La Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (Cofepris) anunci\u00f3 la emisi\u00f3n de\u00a0<strong>nuevos lineamientos<\/strong>\u00a0para reforzar las\u00a0<strong>Buenas Pr\u00e1cticas de Fabricaci\u00f3n<\/strong>\u00a0de\u00a0<strong>f\u00e1rmacos, medicamentos y dispositivos m\u00e9dicos<\/strong>\u00a0en M\u00e9xico.<\/p>\n\n\n\n<p>Esta actualizaci\u00f3n forma parte del compromiso de la autoridad con la&nbsp;<strong>protecci\u00f3n de la salud p\u00fablica<\/strong>&nbsp;y la&nbsp;<strong>modernizaci\u00f3n regulatoria<\/strong>.<\/p>\n\n\n\n<p>Publicados en el&nbsp;<strong>Diario Oficial de la Federaci\u00f3n<\/strong>, los lineamientos buscan garantizar que los insumos para la salud cumplan con est\u00e1ndares internacionales de calidad, seguridad y eficacia, facilitando su acceso eficiente para la poblaci\u00f3n mexicana.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Principales avances en regulaci\u00f3n sanitaria<\/h2>\n\n\n\n<p>Entre los aspectos m\u00e1s relevantes de los nuevos lineamientos destacan:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Aceptaci\u00f3n de certificados de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (CBPF)<\/strong>\u00a0emitidos por autoridades regulatorias internacionales reconocidas.<\/li>\n\n\n\n<li>Digitalizaci\u00f3n de tr\u00e1mites mediante la plataforma\u00a0<strong>DIGIPRiS<\/strong>\u00a0de\u00a0Cofepris, agilizando los procesos de autorizaci\u00f3n.<\/li>\n\n\n\n<li><strong>Alineaci\u00f3n con acuerdos internacionales<\/strong>\u00a0como el PIC\/S y el\u00a0T-MEC, promoviendo la homologaci\u00f3n de regulaciones.<\/li>\n\n\n\n<li>Reconocimiento de est\u00e1ndares de la\u00a0<strong>Organizaci\u00f3n Mundial de la Salud (OMS)<\/strong>\u00a0y de la certificaci\u00f3n ISO 13485:2016 para dispositivos m\u00e9dicos.<\/li>\n\n\n\n<li><strong>Vigencia de 30 meses<\/strong>\u00a0para las certificaciones CBPF, con posibilidad de pr\u00f3rroga de hasta 15 meses en casos justificados.<\/li>\n\n\n\n<li>Inclusi\u00f3n de mecanismos que\u00a0<strong>reducen barreras administrativas<\/strong>\u00a0y facilitan la adopci\u00f3n de regulaciones internacionales por parte de la industria farmac\u00e9utica.<\/li>\n<\/ul>\n\n\n\n<p>Estos cambios permitir\u00e1n fortalecer las capacidades de&nbsp;<strong>vigilancia sanitaria<\/strong>, acelerar el&nbsp;<strong>acceso a insumos m\u00e9dicos de calidad<\/strong>&nbsp;y fomentar la competitividad del sector farmac\u00e9utico nacional.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"has-text-align-center\" style=\"font-size:17px\"><strong><i>Toda la informaci\u00f3n que necesitas saber la encuentras en nuestras <\/i><strong style=\"\"><em style=\"font-style: italic;\">redes sociales y canal de <\/em><\/strong><\/strong><a href=\"https:\/\/t.me\/informantemx\" target=\"_blank\" rel=\"noreferrer noopener\"><strong><em>Telegram<\/em><\/strong><\/a>. <\/p>\n\n\n\n<p class=\"has-text-align-center\" style=\"font-size:17px\"><strong><em>!\u00danete!<\/em><\/strong><\/p>\n\n\n\n<div class=\"wp-block-uagb-image aligncenter uagb-block-3acd28e8 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-zoomin wp-block-uagb-image--align-center\"><figure 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salud.<\/p>\n","protected":false},"author":1,"featured_media":45376,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","jetpack_post_was_ever_published":false,"footnotes":""},"categories":[9],"tags":[31],"class_list":["post-46627","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacional","tag-nacional"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>M\u00e9xico refuerza regulaci\u00f3n sanitaria con nuevos lineamientos - Informante.mx<\/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:\/\/informante.mx\/?p=46627\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" 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