{"id":7964,"date":"2025-01-25T20:29:23","date_gmt":"2025-01-25T20:29:23","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7964"},"modified":"2025-02-13T09:51:38","modified_gmt":"2025-02-13T09:51:38","slug":"anvisa-implements-changes-to-drug-registration","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/anvisa-implements-changes-to-drug-registration\/","title":{"rendered":"Resolution No. 954: Changes to Drug Registration Take Effect"},"content":{"rendered":"<p>The Brazilian Official Gazette has published <strong>Anvisa\u2019s Resolution No. 954<\/strong>, establishing new guidelines for the<strong> simplified process<\/strong> of drug registration, post-registration, and renewal in Brazil.<\/p>\n<p>Coming into effect on <strong>January 21, 2025<\/strong>, the regulation introduces significant innovations and adjustments aimed at enhancing regulatory process management and sanitary control within the pharmaceutical sector.<\/p>\n<p>&nbsp;<\/p>\n<h2>What changes with Resolution No. 954?<\/h2>\n<p>The resolution restricts the simplified procedure to companies within the<strong> same economic group<\/strong>, ensuring uniformity in <strong>safety, quality, and efficacy<\/strong> standards between the original product and its simplified registered counterparts.<\/p>\n<p>This restriction seeks to mitigate health risks identified by GGMED.<\/p>\n<h3><strong><br \/>\nAudits and Transparency<br \/>\n<\/strong><\/h3>\n<p>Among its highlights, the resolution allows <strong>Anvisa to audit simplified registrations<\/strong> at any time.<\/p>\n<p>Companies holding registrations must submit the complete dossier or parts thereof within<strong> 60 days<\/strong> of request.<\/p>\n<p>&nbsp;<\/p>\n<h3>Pricing and Registration Renewal<\/h3>\n<p>The resolution reinforces that <strong>price<\/strong> evaluation criteria remain unchanged, regardless of the registration pathway, as defined by <strong>CMED Resolution No. 2\/2004.<\/strong><\/p>\n<p>Additionally, companies will have <strong>30 days<\/strong> to file post-registration changes for the primary process.<\/p>\n<p>&nbsp;<\/p>\n<h3>Other Key changes<\/h3>\n<ul>\n<li>The primary petition must be linked to a currently valid drug registration.<\/li>\n<li>Specific conditions were established for delinking processes from the simplified model.<\/li>\n<li>Issues related to dual branding will be addressed in future regulatory revisions.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2>Why are these changes important?<\/h2>\n<p>In addition to protecting public health, these measures provide greater predictability and security for drug manufacturers\u2014marking a significant step toward enhancing transparency and efficiency in Brazil\u2019s regulatory processes.<\/p>\n<p>Learn more about the resolution <strong><a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-anvisa-n-954-de-20-de-dezembro-de-2024-603324357\">here<\/a><\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<p>For more information about regulatory issues in Brazil, <strong>ELS can help<\/strong>.<\/p>\n<p>Please\u00a0<a href=\"https:\/\/els-solutions.com\/onde-estamos\/\">contact<\/a> your local ELS consultant or email: info@elssolutions.pt<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>What changes with Anvisa Resolution No. 954? The new regulation, set to take effect on January 21, 2025, introduces adjustments to drug registration, post-registration, and renewal processes, enhancing transparency and sanitary control.<\/p>\n","protected":false},"author":9,"featured_media":7967,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68,54,69,95],"tags":[104,137,140,143,141,142],"class_list":["post-7964","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-els","category-els-group","category-general","category-questoes-regulatorias","category-regulations","tag-anvisa-en","tag-consulta-en","tag-drug-regustration","tag-regulatory","tag-resolution-no-954","tag-transperancy"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Anvisa implements changes to drug registration<\/title>\n<meta name=\"description\" content=\"Anvisa&#039;s Resolution No. 954 brings changes to drug registration, improving transparency and streamlining regulatory processes.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\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\/en\/anvisa-implements-changes-to-drug-registration\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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