{"id":8174,"date":"2025-04-04T03:30:11","date_gmt":"2025-04-03T19:30:11","guid":{"rendered":"https:\/\/regask.com\/?p=8174"},"modified":"2025-04-09T14:29:54","modified_gmt":"2025-04-09T06:29:54","slug":"cumplimiento-de-las-bpm-en-mexico-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/mexico-gmp-compliance-2025\/","title":{"rendered":"COFEPRIS (M\u00e9xico) Publica Lineamientos para Documentos de BPM\u2026"},"content":{"rendered":"<p data-pm-slice=\"1 3 []\">El 20 de marzo de 2025, la Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) public\u00f3 en el Diario Oficial de la Federaci\u00f3n (DOF) el Acuerdo por el que se emiten los Lineamientos para la Presentaci\u00f3n de Documentos que Garantizan las Buenas Pr\u00e1cticas de Manufactura (BPM) de Ingredientes Activos, Medicamentos y Dispositivos M\u00e9dicos. Estos lineamientos aplican a las solicitudes de nuevos registros sanitarios, as\u00ed como a sus pr\u00f3rrogas y modificaciones. La nueva normativa define los requisitos y criterios para la presentaci\u00f3n de la documentaci\u00f3n de BPM, con el objetivo de agilizar el cumplimiento de las normas internacionales y fortalecer la cooperaci\u00f3n con las autoridades regulatorias reconocidas.<\/p>\n<h4><strong>Aspectos destacados clave<\/strong><\/h4>\n<ul data-spread=\"false\">\n<li>Las directrices especifican la documentaci\u00f3n necesaria, incluidos los Certificados de Buenas Pr\u00e1cticas de Manufactura o documentos equivalentes, requeridos para ingredientes farmac\u00e9uticos, medicamentos y dispositivos m\u00e9dicos en las solicitudes de registro sanitario, renovaciones y modificaciones.<\/li>\n<li>Se pone \u00e9nfasis en el cumplimiento de las normas internacionales GMP para garantizar la seguridad, eficacia y consistencia del producto durante todo el proceso de fabricaci\u00f3n.<\/li>\n<li>Las categor\u00edas de productos afectadas incluyen:\n<ul data-spread=\"false\">\n<li>Ingredientes farmac\u00e9uticos activos (API)<\/li>\n<li>Medicamentos de venta libre (OTC)<\/li>\n<li>Medicamentos recetados<\/li>\n<li>Diversos dispositivos m\u00e9dicos, incluidos equipos de diagn\u00f3stico y terap\u00e9uticos<\/li>\n<\/ul>\n<\/li>\n<li>La regulaci\u00f3n promueve la alineaci\u00f3n con autoridades reguladoras reconocidas mundialmente, facilitando potencialmente un acceso m\u00e1s sencillo a productos compatibles en los mercados internacionales.<\/li>\n<li>Se recomienda a los fabricantes que cumplan estrictamente estas pautas para mantener el estado del registro y garantizar un proceso de aprobaci\u00f3n m\u00e1s fluido para registros sanitarios nuevos o modificados.<\/li>\n<\/ul>\n<h4><strong>Pr\u00f3ximos pasos<\/strong><\/h4>\n<ul data-spread=\"false\">\n<li>Los fabricantes deben evaluar y actualizar su documentaci\u00f3n de BPM para alinearla a las nuevas directrices de la COFEPRIS.<\/li>\n<li>Las empresas deben asegurarse de que sus procesos de producci\u00f3n y sistemas de control de calidad cumplan con las expectativas regulatorias revisadas.<\/li>\n<li>El monitoreo estrecho de las actualizaciones regulatorias y la participaci\u00f3n proactiva con COFEPRIS ser\u00e1n esenciales para mantener el cumplimiento y agilizar los procesos de aprobaci\u00f3n.<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>El 20 de marzo de 2025, la Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) public\u00f3 en el Diario Oficial de la Federaci\u00f3n (DOF) el Acuerdo por el que se emiten los Lineamientos para la Presentaci\u00f3n de Documentos que Garantizan las Buenas Pr\u00e1cticas de Manufactura (BPM) de Ingredientes Activos, Medicamentos y Dispositivos M\u00e9dicos. Estos lineamientos aplican a las solicitudes de nuevos registros sanitarios, as\u00ed como\u2026<\/p>","protected":false},"author":43,"featured_media":8207,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[521,35],"tags":[609],"class_list":["post-8174","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico-regulations","category-pharma-biotech-latest-insights","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Mexico GMP 2025: Key Updates | RegASK<\/title>\n<meta name=\"description\" content=\"Stay compliant! COFEPRIS updates GMP rules in 2025. 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