{"id":7909,"date":"2024-12-18T18:51:47","date_gmt":"2024-12-18T10:51:47","guid":{"rendered":"https:\/\/regask.com\/?p=7909"},"modified":"2024-12-18T18:51:47","modified_gmt":"2024-12-18T10:51:47","slug":"pautas-para-la-aprobacion-de-medicamentos-de-dinavisa-en-paraguay","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/paraguay-dinavisa-drug-approval-guideline\/","title":{"rendered":"DINAVISA (Paraguay) Aprueba Nuevo Lineamiento para Buenas Ev\u2026"},"content":{"rendered":"<p>El 2 de diciembre de 2024, el <a href=\"https:\/\/regask.com\/es\/normas-alimentarias-sin-lactosa-de-paraguay\/\">Direcci\u00f3n Nacional de Vigilancia Sanitaria<\/a> (DINAVISA) present\u00f3 la <strong>\u201cGu\u00eda de Buenas Pr\u00e1cticas de Evaluaci\u00f3n para el Registro de Medicamentos\u201d.<\/strong> Esta directriz representa una actualizaci\u00f3n importante del marco regulatorio, centr\u00e1ndose en garantizar la calidad, seguridad y eficacia de los productos farmac\u00e9uticos a trav\u00e9s de procesos de evaluaci\u00f3n claros y transparentes.<\/p>\n<p>La gu\u00eda tiene como objetivo alinear los procedimientos de DINAVISA con los est\u00e1ndares internacionales, fomentando la armonizaci\u00f3n con las normas regulatorias globales. Aplica a todos los productos farmac\u00e9uticos destinados al uso humano, incluyendo medicamentos, productos biol\u00f3gicos, qu\u00edmicos, reactivos, dispositivos m\u00e9dicos y productos de higiene personal clasificados como cosm\u00e9ticos o sanitizantes.<\/p>\n<p>Los aspectos m\u00e1s destacados de la directriz incluyen:<\/p>\n<ul>\n<li>Adherencia a <strong>Normas internacionales<\/strong> y mejores pr\u00e1cticas para la evaluaci\u00f3n de productos medicinales.<\/li>\n<li>Requisitos de cumplimiento detallados para cada etapa del desarrollo del producto, incluidos estudios precl\u00ednicos, autorizaci\u00f3n de ensayos cl\u00ednicos, modificaciones posteriores a la comercializaci\u00f3n y procesos de reinscripci\u00f3n.<\/li>\n<li>\u00c9nfasis en una <strong>enfoque multidisciplinario<\/strong> que integra evaluaciones no cl\u00ednicas, cl\u00ednicas, de biocompatibilidad, de procesos de fabricaci\u00f3n y de gesti\u00f3n de riesgos.<\/li>\n<li>Mecanismos para aprovechar las evaluaciones realizadas por instituciones reconocidas <strong>autoridades reguladoras internacionales<\/strong> para agilizar las revisiones manteniendo estrictos est\u00e1ndares de seguridad y eficacia.<\/li>\n<li>Un enfoque en el fomento <strong>desarrollo profesional continuo<\/strong> y el pensamiento cr\u00edtico entre los evaluadores para garantizar que se tomen decisiones basadas en evidencia y fundamentadas en el conocimiento cient\u00edfico actual.<\/li>\n<\/ul>\n<p>La nueva gu\u00eda es un paso importante hacia la modernizaci\u00f3n y agilizaci\u00f3n del proceso de autorizaci\u00f3n de comercializaci\u00f3n farmac\u00e9utica, garantizando que las decisiones regulatorias sean consistentes, transparentes y alineadas con las pr\u00e1cticas globales.<\/p>\n<p>Para m\u00e1s detalles o consultas, por favor cont\u00e1ctenos.<\/p>","protected":false},"excerpt":{"rendered":"<p>El 2 de diciembre de 2024, la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) present\u00f3 la \u201cGu\u00eda de Buenas Pr\u00e1cticas de Evaluaci\u00f3n para el Registro de Medicamentos\u201d. Esta gu\u00eda representa una importante actualizaci\u00f3n del marco regulatorio, centrada en garantizar la calidad, seguridad y eficacia de los productos farmac\u00e9uticos mediante procesos de evaluaci\u00f3n claros y transparentes. La gu\u00eda tiene como objetivo armonizar\u2026<\/p>","protected":false},"author":43,"featured_media":7926,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,566],"tags":[496,609],"class_list":["post-7909","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-paraguay-regulation","tag-market-authorization-regs","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Paraguay Issues New Guideline for Drug Approvals | RegASK<\/title>\n<meta name=\"description\" content=\"Paraguay\u2019s DINAVISA releases a new guideline for drug approvals, aligning with global standards for safety and efficacy. 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