{"id":8189,"date":"2025-03-09T22:37:09","date_gmt":"2025-03-09T22:37:09","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8189"},"modified":"2025-03-09T22:37:09","modified_gmt":"2025-03-09T22:37:09","slug":"estudos-degradacao-forcada-medicamentos-2","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/estudos-degradacao-forcada-medicamentos-2\/","title":{"rendered":"Publicada a Resolu\u00e7\u00e3o ANVISA N\u00ba 964\/2025: Requisitos para Estudos de Degrada\u00e7\u00e3o For\u00e7ada em Medicamentos"},"content":{"rendered":"<div data-olk-copy-source=\"MessageBody\">\n<div data-olk-copy-source=\"MessageBody\">\n<p>Foi publicada no <strong>Di\u00e1rio Oficial da Uni\u00e3o (DOU)<\/strong> de <strong>24 de fevereiro de 2025<\/strong>, a <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-anvisa-n-964-de-20-de-fevereiro-de-2025-614287718\"><strong>Resolu\u00e7\u00e3o ANVISA N\u00ba 964<\/strong><\/a>, que estabelece requisitos gerais para a realiza\u00e7\u00e3o dos <strong>Estudos de Degrada\u00e7\u00e3o For\u00e7ada<\/strong> em medicamentos contendo <strong>insumos farmac\u00eauticos ativos (IFA)<\/strong> sint\u00e9ticos e semissint\u00e9ticos.<\/p>\n<p>A resolu\u00e7\u00e3o tamb\u00e9m define os par\u00e2metros para a <strong>notifica\u00e7\u00e3o<\/strong>, <strong>identifica\u00e7\u00e3o<\/strong> e <strong>qualifica\u00e7\u00e3o<\/strong> de produtos de degrada\u00e7\u00e3o desses medicamentos. Abaixo, resumimos os pontos mais importantes dessa nova regulamenta\u00e7\u00e3o.<\/p>\n<h3>Objetivo da Resolu\u00e7\u00e3o<\/h3>\n<p>A Resolu\u00e7\u00e3o ANVISA N\u00ba 964\/2025 tem como principal objetivo definir as diretrizes para a realiza\u00e7\u00e3o de <strong>Estudos de Degrada\u00e7\u00e3o For\u00e7ada<\/strong> em medicamentos.<\/p>\n<p>Esses estudos s\u00e3o essenciais para garantir a estabilidade dos medicamentos, avaliando a forma\u00e7\u00e3o de produtos de degrada\u00e7\u00e3o que possam impactar a seguran\u00e7a e a efic\u00e1cia do produto ao longo do tempo.<\/p>\n<h3>Medicamentos Abrangidos<\/h3>\n<p>A resolu\u00e7\u00e3o se aplica exclusivamente a medicamentos que contenham <strong>insumos farmac\u00eauticos ativos sint\u00e9ticos e\/ou semissint\u00e9ticos<\/strong> em sua composi\u00e7\u00e3o, inclusive quando associados a outros IFAs.<\/p>\n<p>No caso de <strong>medicamentos combinados<\/strong>, os crit\u00e9rios da resolu\u00e7\u00e3o devem ser aplicados apenas aos IFAs sint\u00e9ticos e semissint\u00e9ticos presentes na f\u00f3rmula.<\/p>\n<h3><strong>Exce\u00e7\u00f5es \u00e0 Aplicabilidade<\/strong><\/h3>\n<p>A resolu\u00e7\u00e3o <strong>n\u00e3o se aplica<\/strong> a:<\/p>\n<ul>\n<li>IFAs isolados;<\/li>\n<li>Excipientes isolados;<\/li>\n<li>Medicamentos utilizados em <strong>etapas de desenvolvimento de estudos cl\u00ednicos<\/strong>;<\/li>\n<li>Medicamentos que contenham <strong>IFAs biol\u00f3gicos\/biotecnol\u00f3gicos<\/strong>, <strong>pept\u00eddeos<\/strong>, <strong>oligonucleot\u00eddeos<\/strong>, <strong>vitaminas<\/strong>, <strong>minerais<\/strong>, <strong>amino\u00e1cidos<\/strong>, <strong>prote\u00ednas<\/strong>, <strong>compostos inorg\u00e2nicos<\/strong>, entre outros IFAs at\u00edpicos ou derivados de fermenta\u00e7\u00e3o.<\/li>\n<\/ul>\n<h3><strong>Revoga\u00e7\u00e3o de Resolu\u00e7\u00f5es Anteriores<\/strong><\/h3>\n<p>A nova resolu\u00e7\u00e3o revoga as seguintes resolu\u00e7\u00f5es anteriores:<\/p>\n<ul>\n<li><strong>RDC n\u00b0 53, de 4 de dezembro de 2015<\/strong>;<\/li>\n<li><strong>RDC n\u00b0 171, de 22 de agosto de 2017<\/strong>.<\/li>\n<\/ul>\n<h3>Data de Entrada em Vigor<\/h3>\n<\/div>\n<\/div>\n<p>A <strong>Resolu\u00e7\u00e3o ANVISA N\u00ba 964\/2025<\/strong> entra em vigor na <strong>data de sua publica\u00e7\u00e3o<\/strong>, ou seja, <strong>24 de fevereiro de 2025<\/strong>.<\/p>\n<h3><strong>Leitura Recomend\u00e1vel<\/strong><\/h3>\n<p>\u00c9 tamb\u00e9m recomendada a leitura do <a href=\"https:\/\/sindusfarma.org.br\/uploads\/files\/8e1f-diego-paludetti\/2025\/ANVISA\/RDC%20964\/2.2%20(5).pdf\"><strong>Voto n\u00ba 47\/2025\/SEI\/DIRE4\/Anvisa<\/strong><\/a>, que foi emitido durante a <strong>2\u00aa Reuni\u00e3o Ordin\u00e1ria P\u00fablica da Dicol \u2013 2025<\/strong>, realizada no dia <strong>19 de fevereiro de 2025<\/strong>. Este voto oferece uma explica\u00e7\u00e3o detalhada e contextualiza\u00e7\u00e3o da resolu\u00e7\u00e3o.<\/p>\n<div data-olk-copy-source=\"MessageBody\">\n<p><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">Se precisar de mais informa\u00e7\u00f5es sobre <a href=\"https:\/\/els-solutions.com\/servicos\/servicos-regulatorios-medicamentos\/\">quest\u00f5es regulat\u00f3rias de medicamentos<\/a> &#8211; a ELS Group pode ajudar! <\/span><\/p>\n<p><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">Por favor entre em contato com o seu\u00a0<a href=\"https:\/\/els-solutions.com\/onde-estamos\/\" target=\"_blank\" rel=\"noopener\">consultor local da ELS <\/a><\/span><span class=\" author-d-iz88z86z86za0dz67zz78zz78zz74zz68zjz80zz71z9iz90z9z84zmz66zz71znz68znz69zz87z3z89zhz65zz89zybhz84zz79zkwtz79zsz76zdz122zjz80z7\">ou atrav\u00e9s do email: info@elssolutions.pt<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Foi publicada no Di\u00e1rio Oficial da Uni\u00e3o (DOU) de 24 de fevereiro de 2025, a Resolu\u00e7\u00e3o ANVISA N\u00ba 964, que estabelece requisitos gerais para a realiza\u00e7\u00e3o dos Estudos de Degrada\u00e7\u00e3o For\u00e7ada em medicamentos contendo insumos farmac\u00eauticos ativos (IFA) sint\u00e9ticos e semissint\u00e9ticos. A resolu\u00e7\u00e3o tamb\u00e9m define os par\u00e2metros para a notifica\u00e7\u00e3o, identifica\u00e7\u00e3o e qualifica\u00e7\u00e3o de produtos de degrada\u00e7\u00e3o desses medicamentos. Abaixo, resumimos os pontos mais importantes dessa nova regulamenta\u00e7\u00e3o<\/p>\n","protected":false},"author":9,"featured_media":8181,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[84,67,68,53,60,69],"tags":[86,219,218,217],"class_list":["post-8189","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa","category-els","category-els-group","category-geral","category-noticias","category-questoes-regulatorias","tag-anvisa","tag-brasil","tag-estudos-de-degradacao-forcada-em-medicamentos","tag-resolucao-anvisa-no-964"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Estudos de Degrada\u00e7\u00e3o For\u00e7ada em Medicamentos<\/title>\n<meta name=\"description\" content=\"A Resolu\u00e7\u00e3o ANVISA N\u00ba 964, que estabelece requisitos gerais para a realiza\u00e7\u00e3o dos Estudos de Degrada\u00e7\u00e3o For\u00e7ada em medicamentos.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa\" \/>\n<meta property=\"og:description\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa para garantir o abastecimento de produtos cr\u00edticos.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/els-solutions.com\/pt-pt\/estudos-degradacao-forcada-medicamentos-2\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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