{"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> As Boas Pr\u00e1ticas Regulat\u00f3rias (BPR) s\u00e3o um conjunto de princ\u00edpios fundamentais para o fortalecimento dos sistemas de regula\u00e7\u00e3o de medicamentos. <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.\u00a0<\/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>esenvolveram um estudo abrangente para avaliar a ado\u00e7\u00e3o das Boas Pr\u00e1ticas Regulat\u00f3rias (BPR) segundo as recomenda\u00e7\u00f5es da OMS. Este guia oferece orienta\u00e7\u00f5es claras sobre como os sistemas regulat\u00f3rios devem ser estruturados e operados, destacando transpar\u00eancia, independ\u00eancia e flexibilidade nos processos de aprova\u00e7\u00e3o de medicamentos.\u00a0<\/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.\u00a0<\/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>\u00a0Instituto 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>\n","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\/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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