{"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\/pt\/areas-de-trabajo\/apoyo-a-sistemas-regulatorios\/","title":{"rendered":"Apoio aos Sistemas Regulat\u00f3rios"},"content":{"rendered":"<h2 class=\"wp-block-heading\">A qualidade, seguran\u00e7a e efic\u00e1cia dos medicamentos \u00e9 de extrema import\u00e2ncia para a ind\u00fastria farmac\u00eautica e \u00e9 uma \u00e1rea de trabalho priorit\u00e1ria para FIFARMA e os seus membros na Am\u00e9rica Latina e no Caribe.&nbsp;<\/h2>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Para proteger a sa\u00fade dos pacientes, o controle regulamentar por parte das Autoridades Reguladoras Nacionais (ARN) deve impor os mais elevados padr\u00f5es de qualidade e exercer uma vigil\u00e2ncia eficaz dos medicamentos e produtos farmac\u00eauticos ao longo do seu ciclo de vida: desde a investiga\u00e7\u00e3o e desenvolvimento, produ\u00e7\u00e3o, processo de aprova\u00e7\u00e3o sanit\u00e1ria, at\u00e9 \u00e0 distribui\u00e7\u00e3o, utiliza\u00e7\u00e3o e vigil\u00e2ncia do mercado.&nbsp;<\/p>\n\n\n\n<p>Como Federa\u00e7\u00e3o, uma das nossas tarefas \u00e9 contribuir para promover estes elevados padr\u00f5es e boas pr\u00e1ticas regulamentares com uma vis\u00e3o regional e uma perspectiva hol\u00edstica, a fim de fazer progressos decisivos na inova\u00e7\u00e3o sanit\u00e1ria, protegendo ao mesmo tempo a vida e a sa\u00fade dos pacientes. Esta \u00e9 uma vis\u00e3o conjunta que constru\u00edmos a partir do n\u00edvel local, em estreita colabora\u00e7\u00e3o com os governos, as ARN e a ind\u00fastria.&nbsp;<\/p>\n\n\n\n<p>Sistemas reguladores fracos podem ser uma barreira ao acesso a produtos m\u00e9dicos seguros, eficientes e de qualidade. (Resolu\u00e7\u00e3o 67.20 da Assembleia Mundial da Sa\u00fade de 2014). A nossa proposta para todos os atores no ecossistema da sa\u00fade \u00e9 a procura permanente de novas formas de pensar a sa\u00fade numa perspectiva regional, onde as normas de qualidade e seguran\u00e7a dos pacientes, a agilidade e efic\u00e1cia regulamentar, e a prote\u00e7\u00e3o da propriedade intelectual s\u00e3o os nossos pilares.&nbsp;<\/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\">Boas pr\u00e1ticas regulamentares<\/h3>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>FIFARMA apoia a adop\u00e7\u00e3o de boas pr\u00e1ticas regulamentares como um instrumento para refor\u00e7ar os sistemas de sa\u00fade na Am\u00e9rica Latina, a fim de alcan\u00e7ar melhores resultados de sa\u00fade.<\/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\">\u00c1rea 1: Aumentar a transpar\u00eancia<\/h4>\n\n\n\n<p>A transpar\u00eancia \u00e9 um princ\u00edpio essencial para as ARN, pacientes, pagadores, comunidade m\u00e9dica e ind\u00fastria. Promovemos iniciativas de transpar\u00eancia, tais como a publica\u00e7\u00e3o de relat\u00f3rios de avalia\u00e7\u00e3o que acompanham as aprova\u00e7\u00f5es de medicamentos. Isto aumenta a confian\u00e7a das partes interessadas nos medicamentos e outros produtos regulamentados.&nbsp;<\/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\">\u00c1rea 2: Assegurar a coer\u00eancia na aplica\u00e7\u00e3o das diretrizes regulamentares <\/h4>\n\n\n\n<p>O princ\u00edpio da coer\u00eancia no desenvolvimento, implementa\u00e7\u00e3o e aplica\u00e7\u00e3o de regulamentos \u00e9 fundamental e, por conseguinte, \u00e9 tamb\u00e9m considerado uma boa pr\u00e1tica regulamentar. FIFARMA apoia a recomenda\u00e7\u00e3o da OMS de que \"Novos regulamentos devem apoiar e complementar, e n\u00e3o entrar em conflito com os regulamentos existentes\".&nbsp;<\/p>\n\n\n\n<p>Esta harmoniza\u00e7\u00e3o entre a regulamenta\u00e7\u00e3o local e internacional \u00e9 poss\u00edvel se conseguirmos refor\u00e7ar a coopera\u00e7\u00e3o internacional em mat\u00e9ria de regulamenta\u00e7\u00e3o, e facilitar os programas de interc\u00e2mbio nesta \u00e1rea. Como Federa\u00e7\u00e3o, procuramos constantemente construir consensos e instrumentos para o cumprimento de obriga\u00e7\u00f5es decorrentes de tratados internacionais e acordos regionais.&nbsp;<\/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\">\u00c1rea 3: Adop\u00e7\u00e3o da tecnologia para apoiar as boas pr\u00e1ticas regulamentares<\/h4>\n\n\n\n<p>A tecnologia e a digitaliza\u00e7\u00e3o proporcionam novas oportunidades de implementar mecanismos para facilitar e melhorar a atividade dos reguladores. Promovemos e encorajamos a utiliza\u00e7\u00e3o de tecnologias de informa\u00e7\u00e3o e comunica\u00e7\u00e3o para aumentar a agilidade, transpar\u00eancia e efici\u00eancia, bem como para melhorar a elabora\u00e7\u00e3o de relat\u00f3rios e a responsabiliza\u00e7\u00e3o p\u00fablica por parte dos reguladores e da ind\u00fastria farmac\u00eautica.&nbsp;<\/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\">\u00c1rea 4: Apoiar a inova\u00e7\u00e3o impulsionada pelo progresso cient\u00edfico <\/h4>\n\n\n\n<p>As boas pr\u00e1ticas regulamentares apoiam um grau de flexibilidade dentro do ambiente regulamentar para assegurar que a din\u00e2mica da inova\u00e7\u00e3o m\u00e9dica e cient\u00edfica emergente seja reconhecida, sem nunca comprometer a efic\u00e1cia, seguran\u00e7a e qualidade dos medicamentos.<\/p>\n\n\n\n<p>Al\u00e9m disso, as diretrizes da OMS estabelecem que o controle regulamentar n\u00e3o deve ser prescritivo (ou r\u00edgido), mas sim flex\u00edvel para responder a um ambiente em constante evolu\u00e7\u00e3o e a circunst\u00e2ncias imprevistas, estando preparado para dar respostas atempadas a situa\u00e7\u00f5es de emerg\u00eancia, tais como a pandemia de Covid-19.<\/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>Documentos relacionados<\/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\">Position Paper da FIFARMA - Boas Pr\u00e1ticas Regulamentares: permitindo efici\u00eancias regulamentares para a disponibilidade atempada de medicamentos na Am\u00e9rica Latina e no Caribe<\/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 v27.5) - 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\/pt\/areas-de-trabalho\/apoyo-a-sistemas-regulatorios\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\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.&nbsp; 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