{"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>On December 2, 2024, the National Directorate of Sanitary Surveillance (DINAVISA) introduced the &#8220;Guide to Good Evaluation Practices for the Registration of Medicines.&#8221; This guideline represents a major update to the regulatory framework, focusing on ensuring the quality, safety, and efficacy of pharmaceutical products through clear and transparent evaluation processes. The guide aims to align&#8230;<\/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 v27.7 (Yoast SEO v27.8) - 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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