{"id":248,"date":"2022-10-07T06:17:44","date_gmt":"2022-10-07T11:17:44","guid":{"rendered":"https:\/\/fifarma.org\/?post_type=areas-de-trabajo&#038;p=248"},"modified":"2023-05-02T11:29:41","modified_gmt":"2023-05-02T16:29:41","slug":"apoyo-a-sistemas-regulatorios","status":"publish","type":"areas-de-trabajo","link":"https:\/\/fifarma.org\/en\/areas-de-trabajo\/apoyo-a-sistemas-regulatorios\/","title":{"rendered":"Support to Regulatory Systems"},"content":{"rendered":"<h2 class=\"wp-block-heading\">The quality, safety and efficacy of medicines is of paramount importance to the pharmaceutical industry and is a priority area of work for FIFARMA and its members in Latin America and the Caribbean.\u00a0<\/h2>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>To protect the health of patients, regulatory oversight by National Regulatory Authorities (NRAs) must enforce the highest quality standards and exercise effective surveillance of drugs and pharmaceuticals throughout their life cycle: from research and development, production, the sanitary approval process, to distribution, use and market surveillance.\u00a0<\/p>\n\n\n\n<p>As a Federation, one of our tasks is to contribute to promote these high standards and good regulatory practices with a regional vision and an integral perspective to make decisive progress in health innovation, while protecting the life and health of patients. This is a joint vision that we build from the local level, in close collaboration with governments, NRAs and industry.\u00a0<\/p>\n\n\n\n<p>Weak regulatory systems can be a barrier to access to safe, efficient, and quality medical products. (World Health Assembly Resolution 67.20 of 2014). Our proposal for all stakeholders in the healthcare ecosystem is the permanent search for new ways of thinking about healthcare from a regional perspective, where quality and safety standards for patients, regulatory agility and effectiveness, and the protection of intellectual property are our pillars.\u00a0<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Good Regulatory Practices<\/h3>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>FIFARMA supports the adoption of good regulatory practices as a tool to strengthen health systems in Latin America in order to achieve better health outcomes.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" width=\"134\" height=\"134\" src=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/10\/iconos_fifarma-21.png\" alt=\"\" class=\"wp-image-2211 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<h4 class=\"wp-block-heading\">Area 1: Increasing transparency<\/h4>\n\n\n\n<p>Transparency is an essential principle for NRAs, patients, payers, the medical community, and industry. We promote transparency initiatives such as, for example, the publication of evaluation reports accompanying drug approvals. This increases stakeholder confidence in medicines and other regulated products.\u00a0<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" width=\"134\" height=\"134\" src=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/iconos_fifarma-22.png\" alt=\"\" class=\"wp-image-2212 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<h4 class=\"wp-block-heading\">Area 2: Ensuring consistency in the application of regulatory guidelines <\/h4>\n\n\n\n<p>The principle of consistency in the development, implementation and enforcement of regulations is fundamental and is therefore also considered a good regulatory practice. FIFARMA supports the WHO recommendation that \"New regulations should support and complement, and not conflict with, existing regulations\".\u00a0<\/p>\n\n\n\n<p>This harmonization between local and international regulation is possible if we strengthen international regulatory cooperation and facilitate exchange programs in this area. As a Federation, we are constantly seeking to build consensus and tools for compliance with the obligations deriving from international treaties and regional agreements.\u00a0<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" width=\"134\" height=\"134\" src=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/iconos_fifarma-23.png\" alt=\"\" class=\"wp-image-2213 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<h4 class=\"wp-block-heading\">Area 3: Adopting technology to support good regulatory practices<\/h4>\n\n\n\n<p>La tecnolog\u00eda y la digitalizaci\u00f3n brindan nuevas oportunidades de implementar mecanismos para facilitar y mejorar la actividad de los entes reguladores. Promovemos e impulsamos el uso de las tecnolog\u00edas de informaci\u00f3n y las comunicaciones para incrementar su agilidad,\u00a0 transparencia y eficacia, as\u00ed como para mejorar los reportes y la rendici\u00f3n p\u00fablica de cuentas por parte de los entes reguladores y la\u00a0 industria farmac\u00e9utica.\u00a0<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top\" style=\"grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"134\" height=\"134\" src=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/12\/iconos_fifarma-24.png\" alt=\"\" class=\"wp-image-2214 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<h4 class=\"wp-block-heading\">Area 4: Supporting innovation driven by scientific progress <\/h4>\n\n\n\n<p>Good regulatory practice supports a degree of flexibility within the regulatory environment to ensure that the dynamics of emerging medical and scientific innovation are recognized, without ever compromising the efficacy, safety, and quality of medicines.<\/p>\n\n\n\n<p>In addition, WHO guidelines state that regulatory oversight should not be prescriptive (or rigid), but should be flexible to respond to a constantly evolving environment and unforeseen circumstances, being prepared to provide timely responses to emergency situations, as in the case of the Covid-19 pandemic.<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:78px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Related documents<\/strong><\/h4>\n\n\n\n<p><a href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2023\/01\/Buenas-Practicas-Regulatorias-habilitando-eficiencias-regulatorias-para-la-disposicion-de-medicamentos-de-manera-oportuna-en-America-Latina-y-el-Caribe.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">FIFARMA Position Paper - Good Regulatory Practices: Enabling regulatory efficiencies for timely drug disposition in Latin America and the Caribbean<\/a><\/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},"featured_media":1714,"template":"","class_list":["post-248","areas-de-trabajo","type-areas-de-trabajo","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.7 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Apoyo a Sistemas Regulatorios - FIFARMA<\/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:\/\/fifarma.org\/en\/work-areas\/apoyo-a-sistemas-regulatorios\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Apoyo a Sistemas Regulatorios\" \/>\n<meta property=\"og:description\" content=\"La calidad, seguridad y eficacia de los medicamentos es primordial para la industria farmac\u00e9utica y es un \u00e1rea de trabajo prioritario para FIFARMA y sus miembros en Am\u00e9rica Latina y el Caribe.\u00a0 Para proteger la salud de los pacientes, la supervisi\u00f3n regulatoria, por parte de las Autoridades Reguladoras Nacionales (ARN) debe hacer cumplir los m\u00e1s [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fifarma.org\/en\/work-areas\/apoyo-a-sistemas-regulatorios\/\" \/>\n<meta property=\"og:site_name\" content=\"FIFARMA\" \/>\n<meta property=\"article:modified_time\" content=\"2023-05-02T16:29:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/fifarma.org\/wp-content\/uploads\/2022\/10\/AdobeStock_31456366-scaled.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"2048\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fifarma.org\\\/areas-de-trabajo\\\/apoyo-a-sistemas-regulatorios\\\/\",\"url\":\"https:\\\/\\\/fifarma.org\\\/areas-de-trabajo\\\/apoyo-a-sistemas-regulatorios\\\/\",\"name\":\"Apoyo a Sistemas Regulatorios - 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