{"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\/pt\/obpr\/","title":{"rendered":"Boas Pr\u00e1ticas Regulat\u00f3rias: princ\u00edpios que transformam a sa\u00fade global"},"content":{"rendered":"<p><em>Segundo dados da OMS, mais de dois bilh\u00f5es de pessoas n\u00e3o t\u00eam acesso a produtos m\u00e9dicos essenciais, uma situa\u00e7\u00e3o que afeta particularmente os pa\u00edses em desenvolvimento, onde as barreiras regulat\u00f3rias s\u00e3o um dos fatores que limitam a disponibilidade de tratamentos seguros e eficazes.<\/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\">Acesse o relat\u00f3rio completo<\/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\">Baixe aqui<\/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>5 de dezembro de 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\" target=\"_blank\" rel=\"noreferrer noopener\">A Organiza\u00e7\u00e3o Mundial da Sa\u00fade (OMS)<\/a> destacou que sistemas regulat\u00f3rios s\u00f3lidos s\u00e3o essenciais para superar barreiras no acesso a produtos m\u00e9dicos de qualidade e avan\u00e7ar em dire\u00e7\u00e3o a metas globais, como a cobertura universal de sa\u00fade.&nbsp;<\/p>\n\n\n\n<p>Todos os medicamentos precisam passar por uma aprova\u00e7\u00e3o regulat\u00f3ria e, na Am\u00e9rica Latina, as ag\u00eancias reguladoras nacionais, respons\u00e1veis por essa aprova\u00e7\u00e3o, ainda enfrentam grandes desafios. Considerando esses desafios e a necessidade de continuar fortalecendo os sistemas regulat\u00f3rios de produtos farmac\u00eauticos na regi\u00e3o como uma prioridade estrat\u00e9gica para melhorar os resultados em sa\u00fade p\u00fablica, a FIFARMA<sup>1<\/sup> e a <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>Este relat\u00f3rio, que avalia a ado\u00e7\u00e3o das BPR em 8 pa\u00edses da regi\u00e3o \u2014 Argentina, Brasil, Chile, Col\u00f4mbia, Costa Rica, Equador, M\u00e9xico e Peru \u2014 busca oferecer recomenda\u00e7\u00f5es-chave para atender \u00e0s necessidades espec\u00edficas de cada pa\u00eds no fortalecimento de seus sistemas regulat\u00f3rios. Al\u00e9m disso, prop\u00f5e estrat\u00e9gias para garantir processos regulat\u00f3rios mais eficientes e previs\u00edveis.&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>Principais descobertas<\/strong><\/h4>\n\n\n\n<p>O relat\u00f3rio baseia-se em uma pesquisa realizada com especialistas em assuntos regulat\u00f3rios dos 8 pa\u00edses mencionados. No total, foram recebidas <strong>240 respostas<\/strong>principalmente de laborat\u00f3rios multinacionais (65%) e nacionais (7,1%), al\u00e9m de consultores em servi\u00e7os regulat\u00f3rios (14,6%) e representantes de autoridades regulat\u00f3rias nacionais (2,1%). A pesquisa destaca o alto n\u00edvel de experi\u00eancia dos participantes, sendo que 44% relataram ter <strong>16 anos ou mais de trajet\u00f3ria<\/strong> <strong>de trayectoria<\/strong> no setor farmac\u00eautico, com especializa\u00e7\u00f5es em Assuntos Regulat\u00f3rios (45,5%) e Farmacovigil\u00e2ncia (19,5%), garantindo que os resultados refletem perspectivas bem fundamentadas e com profundo conhecimento t\u00e9cnico.<br><br>Para avaliar a implementa\u00e7\u00e3o das Boas Pr\u00e1ticas Regulat\u00f3rias, foi utilizada uma escala de <strong>0 a 100<\/strong> para medir o n\u00edvel de ado\u00e7\u00e3o, classificado em tr\u00eas categorias: <strong>B\u00e1sico<\/strong> (implementa\u00e7\u00e3o inicial), <strong>Intermedi\u00e1rio<\/strong> (progressos significativos com \u00e1reas pendentes) e <strong>Avan\u00e7ado<\/strong> (principios completamente integrados y aplicados de manera consistente). Este enfoque metodol\u00f3gico permiti\u00f3 identificar con claridad los avances y desaf\u00edos en la implementaci\u00f3n de las BPR en la regi\u00f3n, proporcionando una base s\u00f3lida para priorizar esfuerzos y fortalecer los sistemas regulatorios.<\/p>\n\n\n\n<p>Os resultados mostram que, embora mais de <strong>0% das entidades tenham um n\u00edvel intermedi\u00e1rio na ado\u00e7\u00e3o dessas pr\u00e1ticas, menos de 20% alcan\u00e7aram um n\u00edvel avan\u00e7ado em princ\u00edpios-chave como flexibilidade e efici\u00eancia.<\/strong> Por exemplo, no princ\u00edpio da legalidade, as pontua\u00e7\u00f5es variam de 44,4 na Col\u00f4mbia a 75,0 no Brasil, enquanto na efici\u00eancia, as pontua\u00e7\u00f5es oscilam entre 56,8 na Col\u00f4mbia e 67,1 no M\u00e9xico e Costa Rica.<\/p>\n\n\n\n<p>Al\u00e9m disso<strong> apenas 15% dos pa\u00edses alinharam suas regula\u00e7\u00f5es com padr\u00f5es internacionais,<\/strong>dificultando a chegada de tratamentos inovadores e atrasando respostas a emerg\u00eancias de sa\u00fade p\u00fablica. Pa\u00edses com n\u00edveis mais baixos de implementa\u00e7\u00e3o enfrentam processos regulat\u00f3rios que podem se estender por at\u00e9 dois anos, limitando a capacidade dos sistemas de sa\u00fade de responderem eficazmente \u00e0s necessidades cr\u00edticas da popula\u00e7\u00e3o.<\/p>\n\n\n\n<p>Por outro lado, os habilitadores das BPR tamb\u00e9m apresentam grandes desafios. A regi\u00e3o demonstra um baixo n\u00edvel de recursos financeiros sustent\u00e1veis, com uma pontua\u00e7\u00e3o m\u00e9dia de 45,9, e uma progress\u00e3o m\u00e9dia em recursos humanos competentes (52,9). No entanto, \u00e1reas como \u00e9tica institucional (63,7) e transpar\u00eancia (61,4) refletem um progresso significativo, destacando o compromisso dos pa\u00edses com a melhoria cont\u00ednua.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\"Este relat\u00f3rio evidencia a import\u00e2ncia das BPR como motor para sistemas regulat\u00f3rios mais s\u00f3lidos e eficazes, fundamentais para garantir a seguran\u00e7a e a sa\u00fade dos pacientes na Am\u00e9rica Latina. Nossa parceria com a INNOS refor\u00e7a nosso compromisso de continuar avan\u00e7ando em dire\u00e7\u00e3o a um sistema regulat\u00f3rio que permita um acesso mais oportuno e equitativo a tratamentos inovadores\", <\/em>afirmou Diego Salas, Diretor de Assuntos Regulat\u00f3rios da FIFARMA.<\/p>\n<\/blockquote>\n\n\n\n<p>A ado\u00e7\u00e3o das BPR permitir\u00e1 que os sistemas de sa\u00fade da Am\u00e9rica Latina respondam com maior efic\u00e1cia \u00e0s necessidades dos pacientes, acelerem o acesso a medicamentos essenciais e garantam sua sustentabilidade a longo prazo. Este esfor\u00e7o conjunto entre FIFARMA e INNOS marca um primeiro passo para fomentar a colabora\u00e7\u00e3o entre governos, autoridades regulat\u00f3rias e a ind\u00fastria farmac\u00eautica, com o objetivo de beneficiar milh\u00f5es de pessoas na regi\u00e3o.<\/p>\n\n\n\n<p>Contato de imprensa<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> Federa\u00e7\u00e3o Latino-Americana da Ind\u00fastria Farmac\u00eautica<\/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 v27.4) - 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\/pt\/obpr\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\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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