{"id":8208,"date":"2024-08-28T11:29:57","date_gmt":"2024-08-28T16:29:57","guid":{"rendered":"https:\/\/fifarma.org\/?p=8208"},"modified":"2024-09-02T17:25:00","modified_gmt":"2024-09-02T22:25:00","slug":"reliance-homologacion-regulatoria-para-acelerar-el-acceso-a-medicamentos","status":"publish","type":"post","link":"https:\/\/fifarma.org\/pt\/reliance-homologacion-regulatoria-para-acelerar-el-acceso-a-medicamentos\/","title":{"rendered":"Reliance: homologaci\u00f3n regulatoria para acelerar el acceso a medicamentos\u00a0"},"content":{"rendered":"<p class=\"has-text-align-right has-small-font-size\">Yaneth Giha<br>FIFARMA<br>Diretora Executiva<\/p>\n\n\n\n<p>El mecanismo de <em>reliance<\/em> es una alternativa costo-eficiente que tienen a su disposici\u00f3n las autoridades regulatorias nacionales (ARN) para acortar los tiempos de espera que experimentan los pacientes que necesitan acceder a medicamentos de \u00faltima generaci\u00f3n.<br><br>En febrero de 2024, lanzamos la segunda versi\u00f3n del <a href=\"https:\/\/fifarma.org\/pt\/wait-indicator-hacia-el-pragmatismo-responsable-en-la-medicion-del-acceso-a-nuevas-tecnologias-en-america-latina-2\/\">FIFARMA W.A.I.T<\/a>. (<em>Waiting to Access Innovative Therapies)<\/em> Indicator 2023 para Latinoam\u00e9rica, un estudio que analiza los tiempos de disponibilidad y aprobaci\u00f3n de 228 tratamientos innovadores contra el c\u00e1ncer y las enfermedades hu\u00e9rfanas, desde que son aprobados por las agencias regulatorias de Estados Unidos (FDA) y la Uni\u00f3n Europea (EMA) hasta que est\u00e1n disponibles para los pacientes en ocho pa\u00edses latinoamericanos.<br><br>El informe establece que el tiempo promedio de espera desde la aprobaci\u00f3n de la FDA hasta la disponibilidad efectiva para los pacientes de la regi\u00f3n, oscila entre 1,9 y m\u00e1s de 4,5 a\u00f1os.<br><br>Estos tiempos pueden mejorar significativamente si las agencias nacionales adoptan con mayor \u00e9nfasis, buenas pr\u00e1cticas internacionales como el <em>reliance<\/em>.<br><br>Desde 1995 la <a href=\"https:\/\/www.who.int\">Organizaci\u00f3n Mundial de la Salud<\/a> (OMS) promueve la toma de decisiones regulatorias basada en la cooperaci\u00f3n y confianza entre agencias regulatorias nacionales bajo este mecanismo, que permite que una autoridad nacional tome como referencia los an\u00e1lisis y decisiones de otro pa\u00eds, y las utilice como aporte al proceso de aprobaci\u00f3n de un medicamento en su propia jurisdicci\u00f3n.<br><br>O <em>reliance<\/em> tiene beneficios probados, impactando positivamente al ecosistema de salud en su conjunto.\u00a0<br><br>Los principales beneficiarios de procesos de aprobaci\u00f3n regulatoria m\u00e1s \u00e1giles son los pacientes, que dependen recuperaci\u00f3n de medicamentos de \u00faltima generaci\u00f3n.<br><br>La Asamblea Mundial de Salud de 2014, identific\u00f3 a los sistemas de salud y particularmente a las autoridades regulatorias, como un eje fundamental para asegurar que las medicinas lleguen de manera oportuna a los pacientes.<br><br>Las agencias nacionales que adoptan el mecanismo de <em>reliance<\/em> logran un modelo de trabajo inteligente y eficiente, evitando la duplicaci\u00f3n de esfuerzos y optimizando el uso recursos limitados.\u00a0<br><br>En los pa\u00edses en desarrollo, como es el caso de latinoam\u00e9rica, a menudo los pa\u00edses enfrentan limitaciones de recursos financieros, de capital humano especializado y de equipos tecnol\u00f3gicos. El mecanismo de <em>reliance<\/em> puede compensar parte de estas limitaciones y ofrecer canales de intercambio de informaci\u00f3n que brinde acceso r\u00e1pido a conocimiento t\u00e9cnico, resultado de ensayos cl\u00ednicos y producci\u00f3n cient\u00edfica de otras agencias del mundo.<br><br>Por supuesto, las compa\u00f1\u00edas que manufacturan estos tratamientos innovadores se benefician al tener procesos m\u00e1s \u00e1giles, claros y predecibles de aprobaci\u00f3n regulatoria para sus productos. Esto garantiza cadenas de suministro confiables para los sistemas de salud y los pacientes.<br><br>Tampoco se debe pasar por alto el impacto que tiene el mecanismo de <em>reliance<\/em> sobre la armonizaci\u00f3n de los est\u00e1ndares regulatorios a nivel global, lo que resulta crucial en un mundo interconectado. Esta armonizaci\u00f3n puede contribuir, por ejemplo, a una respuesta global coordinada y m\u00e1s efectiva en situaciones de emergencia sanitaria. Esto se pudo constatar con la pandemia del Covid-19 donde el mecanismo de <em>reliance <\/em>permiti\u00f3 un proceso de aprobaci\u00f3n regulatoria en tiempo r\u00e9cord para asegurar que las vacunas estuvieran disponibles para la poblaci\u00f3n alrededor del mundo.<br><br>Desde FIFARMA ofrecemos nuestro apoyo a las agencias regulatorias de Latinoam\u00e9rica para facilitar la adopci\u00f3n de buenas pr\u00e1cticas internacionales, como el mecanismo de <em>Reliance<\/em>, para que haya un acceso m\u00e1s oportuno a medicamentos innovadores para los pacientes de la regi\u00f3n.<\/p>\n\n    <div class=\"xs_social_share_widget xs_share_url after_content \t\tmain_content  wslu-style-1 wslu-share-box-shaped wslu-fill-colored wslu-none wslu-share-horizontal wslu-theme-font-no wslu-main_content\">\n\n\t\t\n        <ul>\n\t\t\t        <\/ul>\n    <\/div>","protected":false},"excerpt":{"rendered":"<p>El mecanismo de reliance es una alternativa costo-eficiente que tienen a su disposici\u00f3n las autoridades regulatorias nacionales (ARN) para acortar los tiempos de espera que experimentan los pacientes que necesitan acceder a medicamentos de \u00faltima generaci\u00f3n.<\/p>","protected":false},"author":24,"featured_media":8209,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"enableOnePageScrollInPage":false,"onePageScrollCss":"","onePageScrollSpeed":1000,"onePageScrollAnimation":"easeInOutQuad","onePageScrollShowDotNavigation":true,"onePageScrollNavigation":"scaleUp","onePageScrollNavigationPosition":"right","onePageScrollNavigationHorizontal":[],"onePageScrollNavigationVertical":[],"onePageScrollNavigationSpacing":[],"onePageScrollNavigationColor":"#00ff0d","onePageScrollNavigationColorHover":"#00ff0d","onePageScrollNavigationColorActive":"#00ff0d","onePageScrollNavigationIcon":[],"onePageScrollNavigationWidth":[],"onePageScrollNavigationWidthHover":[],"onePageScrollNavigationWidthActive":[],"onePageScrollNavigationHeight":[],"onePageScrollNavigationHeightHover":[],"onePageScrollNavigationHeightActive":[],"onePageScrollNavigationBorder":[],"onePageScrollNavigationBorderHover":[],"onePageScrollNavigationBorderActive":[],"onePageScrollNavigationBorderRadius":[],"onePageScrollNavigationBorderRadiusHover":[],"onePageScrollNavigationBorderRadiusActive":[],"onePageScrollNavigationTooltipTypography":[],"onePageScrollNavigationTooltipColor":"#ffffff","onePageScrollNavigationTooltipColorHover":"","onePageScrollNavigationTooltipBgColor":"#00ff0d","onePageScrollNavigationTooltipBgColorHover":"","onePageScrollNavigationTooltipPadding":[],"onePageScrollNavigationTooltipPaddingHover":[],"onePageScrollNavigationTooltipBorderRadius":[],"onePageScrollNavigationTooltipBorderRadiusHover":[],"pageSettingsCustomCss":"","footnotes":""},"categories":[149,1],"tags":[26,146,49,122],"class_list":["post-8208","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reliance","category-sin-categoria","tag-america-latina","tag-reliance","tag-salud","tag-w-a-i-t-indicator"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.7 (Yoast SEO v27.4) - 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