{"id":8644,"date":"2024-12-04T14:58:15","date_gmt":"2024-12-04T19:58:15","guid":{"rendered":"https:\/\/fifarma.org\/?p=8644"},"modified":"2025-01-21T12:42:04","modified_gmt":"2025-01-21T17:42:04","slug":"obpr","status":"publish","type":"post","link":"https:\/\/fifarma.org\/en\/obpr\/","title":{"rendered":"Good Regulatory Practices: principles that transform global health"},"content":{"rendered":"<p><em>According to WHO data, more than two billion people lack access to essential medical products, a situation that particularly affects developing countries where regulatory barriers are one of the factors limiting the availability of safe and effective treatments.<\/em><\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-center has-large-font-size\">Access the full report<\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\" href=\"https:\/\/fifarma.org\/wp-content\/uploads\/2025\/01\/Observatorio-de-Buenas-Praicticas-Regulatorias.-.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Download here<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>December 5, 2024.<\/strong> Las Buenas Pr\u00e1cticas Regulatorias (BPR) son un conjunto de principios clave para el fortalecimiento de los sistemas de regulaci\u00f3n de medicamentos.&nbsp; La <a href=\"https:\/\/www.who.int\/es\" target=\"_blank\" rel=\"noreferrer noopener\">World Health Organization (WHO)<\/a> stressed that strong regulatory systems are essential to overcome barriers to access to quality medical products and to move towards global goals such as universal health coverage.&nbsp;<\/p>\n\n\n\n<p>All medicines must undergo regulatory approval, and in Latin America, national regulatory agencies (in charge of this approval) still face major challenges. Taking into account these challenges, and the need to continue strengthening the pharmaceutical regulatory systems in the region as a strategic priority to improve public health outcomes, FIFARMA<sup>1<\/sup> and <a href=\"https:\/\/www.innos.co\/\" target=\"_blank\" rel=\"noreferrer noopener\">INNOS<sup>2<\/sup><\/a>, desarrollaron un estudio integral para evaluar la adopci\u00f3n de las Buenas Pr\u00e1cticas Regulatorias (BPR) seg\u00fan las recomendaciones de la Organizaci\u00f3n Mundial de la Salud (OMS), que ofrece una gu\u00eda clara sobre c\u00f3mo deben estructurarse y operar los sistemas regulatorios, destacando la transparencia, independencia y flexibilidad&nbsp; en los procesos de aprobaci\u00f3n de medicamentos.&nbsp;<\/p>\n\n\n\n<p>This report, which assesses the adoption of GRPs in eight countries in the region: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru, seeks to offer key recommendations in response to the specific needs of each country to strengthen their regulatory systems. It also proposes strategies to ensure more efficient and predictable regulatory processes.&nbsp;<\/p>\n\n\n\n<div style=\"height:38px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Main findings<\/strong><\/h4>\n\n\n\n<p>The report is based on a survey of regulatory affairs experts in the 8 countries mentioned above. In total, 1,000 respondents were received <strong>240 answers<\/strong>, mainly from multinational (65%) and national (7.1%) laboratories, as well as regulatory services consultants (14.6%) and representatives of national regulatory authorities (2.1%). The survey highlights the high level of experience of the participants, since 44% reported having <strong>16 years or older<\/strong> <strong>de trayectoria<\/strong> in the pharmaceutical sector, with specializations in Regulatory Affairs (45.5%) and Pharmacovigilance (19.5%), ensuring that the findings reflect well-founded perspectives and deep technical knowledge.<br><br>To evaluate the implementation of Good Regulatory Practices, a scale of <strong>0 to 100<\/strong> to measure the level of adoption, classified into three categories: <strong>Basic<\/strong> (initial implementation), <strong>Intermediate<\/strong> (significant progress with pending areas) and <strong>Advanced<\/strong> (principles fully integrated and consistently applied). This methodological approach made it possible to clearly identify the progress and challenges in the implementation of GRP in the region, providing a solid basis for prioritizing efforts and strengthening regulatory systems.<\/p>\n\n\n\n<p>The results show that, <strong>Although more than 60% of organizations have an intermediate level in the adoption of these practices, less than 20% have reached an advanced level in key principles such as flexibility and efficiency.<\/strong> For example, in the principle of legality, scores range from 44.4 in Colombia to 75.0 in Brazil, while in efficiency, scores range from 56.8 in Colombia to 67.1 in Mexico and Costa Rica.<\/p>\n\n\n\n<p>Besides,<strong> only 15% of countries have aligned their regulations with international standards<\/strong>, which hinders the arrival of innovative treatments and delays the response to public health emergencies. Countries with lower levels of implementation face regulatory processes that can extend up to two more years, limiting the capacity of health systems to respond effectively to the critical needs of the population.<\/p>\n\n\n\n<p>On the other hand, GPR enablers also present major challenges. The region shows a low level of sustainable financial resources, with an average score of 45.9, and a medium progression in competent human resources (52.9). However, areas such as institutional ethics (63.7) and transparency (61.4) reflect significant progress in the region, highlighting the countries' commitment to continuous improvement.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis report highlights the importance of GRP as a driver of more robust and effective regulatory systems, which are essential to guarantee the safety and health of patients in Latin America. Our alliance with INNOS reinforces our commitment to continue moving towards a regulatory system that allows more timely and equitable access to innovative treatments,\u201d <\/em>said Diego Salas, Director of Regulatory Affairs at FIFARMA.<\/p>\n<\/blockquote>\n\n\n\n<p>The adoption of GRPs will enable health systems in Latin America to respond more effectively to patient needs, accelerate access to essential medicines and ensure their long-term sustainability. This joint effort between FIFARMA and INNOS marks a first step towards fostering collaboration between governments, regulatory authorities and the pharmaceutical industry, with the aim of benefiting millions of people in the region.<\/p>\n\n\n\n<p>Press contact<br>Raquel Sorza<br>rsorza@fifarma.org<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"has-small-font-size\"><sup>1<\/sup> Latin American Federation of the Pharmaceutical Industry<\/p>\n\n\n\n<p class=\"has-small-font-size\"><sup>2<\/sup>&nbsp;Instituto de Prospectiva e Innovaci\u00f3n en Salud<\/p>\n\n\n\n<p><\/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>Seg\u00fan datos de la OMS, m\u00e1s de dos mil millones de personas carecen de acceso a productos m\u00e9dicos esenciales, una situaci\u00f3n que afecta particularmente a los pa\u00edses en desarrollo donde las barreras regulatorias son uno de los factores que limitan la disponibilidad de tratamientos seguros y eficaces. Accede al informe completo 5 de diciembre de [&hellip;]<\/p>","protected":false},"author":24,"featured_media":8651,"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":[180,6],"tags":[98,26,179,60,80,49],"class_list":["post-8644","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-buenas-practicas-regulatorias","category-publicaciones","tag-acceso","tag-america-latina","tag-buenas-practicas-regulatorias","tag-fifarma","tag-pacientes","tag-salud"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.7 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Buenas Pr\u00e1cticas Regulatorias: principios que transforman la salud global - 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\/obpr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Buenas Pr\u00e1cticas Regulatorias: principios que transforman la salud global\" \/>\n<meta property=\"og:description\" content=\"Seg\u00fan datos de la OMS, m\u00e1s de dos mil millones de personas carecen de acceso a productos m\u00e9dicos esenciales, una situaci\u00f3n que afecta particularmente a los pa\u00edses en desarrollo donde las barreras regulatorias son uno de los factores que limitan la disponibilidad de tratamientos seguros y eficaces. 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