{"id":4919,"date":"2026-08-17T10:35:48","date_gmt":"2026-08-17T13:35:48","guid":{"rendered":"https:\/\/feadv.com.br\/?p=4919"},"modified":"2026-08-17T10:35:48","modified_gmt":"2026-08-17T13:35:48","slug":"new-cmed-regulatory-framework-for-drug-pricing-what-changes-for-the-pharmaceutical-sector","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/novo-marco-regulatorio-da-cmed-para-precificacao-de-medicamentos-o-que-muda-para-o-setor-farmaceutico\/","title":{"rendered":"New CMED regulatory framework for drug pricing: what changes for the pharmaceutical sector"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"4919\" class=\"elementor elementor-4919\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-18a470c4 e-flex e-con-boxed e-con e-parent\" data-id=\"18a470c4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fb89604 elementor-widget elementor-widget-text-editor\" data-id=\"4fb89604\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">On May 29, 2026, Resolution No. 3\/2025 of the Chamber of Regulation of the Medicine Market (CMED) came into force, restructuring the methodology for setting the commercialization prices of pharmaceutical products in the country.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The standard replaces the former Resolution No. 2\/2004, updating the categorization rules and factory price ceilings for new registrations and launches.<br><br><\/span><\/p>\n<h3><strong>The main changes brought by Resolution No. 3\/2025<\/strong><\/h3>\n<p><span style=\"font-weight: 400;\">Regulatory changes are divided into three major fronts:<\/span><\/p><p><b>Creation of new categories<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The standard introduces two new rating bands:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Category 7 (Biosimilars): <\/b><span style=\"font-weight: 400;\">It establishes a price cap, stipulating that the initial Factory Price (PF) may not exceed 80% of the reference originator biologic\u2019s price.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Category 8 (Transfer of ownership):<\/b><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"> it is intended for products undergoing registration changes, with specific pricing rules depending on the transmission scenario.<\/span><\/span>\n<p><\/p>\n<\/li>\n<\/ul>\n<p><b>Ex officio price fixing<\/b><\/p>\n<p><span style=\"font-weight: 400;\">CMED assumes a stricter prerogative of active intervention. The agency may set prices (provisional or final) on its own initiative if the product obtains registration without an associated price after March 2004 or if the laboratory fails to submit the Price Information Document (DIP).<\/span><\/p>\n<p><b>Adjustments to traditional categories<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Category 1: <\/b><span style=\"font-weight: 400;\">The ceiling price is now indexed to the lowest value practiced internationally among the comparison countries. The new feature is the end of the requirement for an active patent in Brazil to qualify for this modality.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Category 3:<\/b><span style=\"font-weight: 400;\"> limited to drugs with proven incremental innovation. If clinical superiority is not demonstrated, the launch price is capped at that of the existing comparator product.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Categories 4 and 5: <\/b><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">restructured to use market-weighted averages or those of presentations already commercialized by the same company and its economic group.<br><\/span><\/span><\/li>\n<\/ul><div><br><br><\/div>\n<h3><strong>The impact for manufacturers and distributors<\/strong><\/h3>\n<p><span style=\"font-weight: 400;\">Resolution No. 3\/2025 amends the starting point for the profitability of new products, requiring laboratories to revise their financial launch models and sanitary registration strategies.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For the biosimilars segment, the 80% cap set by the originator establishes a clear competitive limit. On the other hand, for high-tech medicines, the relaxation of patent requirements in Category 1 may benefit the pricing positioning of products with clinical advantages in the international market.<br><br><\/span><\/p>\n<h3><strong>Drug Pricing in Brazil: What the New CMED Resolution Establishes<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3bbd9f0 e-flex e-con-boxed e-con e-parent\" data-id=\"3bbd9f0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f69a99c elementor-widget elementor-widget-n-accordion\" data-id=\"f69a99c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2580\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2580\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How did CMED limit the marketing prices of biosimilars? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2580\" class=\"elementor-element elementor-element-388cadc e-con-full e-flex e-con e-child\" data-id=\"388cadc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2580\" class=\"elementor-element elementor-element-4b4e72c e-flex e-con-boxed e-con e-child\" data-id=\"4b4e72c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aadc7fe elementor-widget elementor-widget-text-editor\" data-id=\"aadc7fe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The new rule classifies biosimilars under Category 7, stipulating that their initial factory price may not exceed 80% of the maximum approved price for the corresponding reference biologic.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2581\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2581\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Under what circumstances can CMED set prices through mandatory regulations? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2581\" class=\"elementor-element elementor-element-69e932f e-con-full e-flex e-con e-child\" data-id=\"69e932f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2581\" class=\"elementor-element elementor-element-995a225 e-flex e-con-boxed e-con e-child\" data-id=\"995a225\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-232635e elementor-widget elementor-widget-text-editor\" data-id=\"232635e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Chamber may establish prices ex officio if the manufacturer fails to submit the Price Information Document (DIP) or if there are older records without defined prices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2582\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2582\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What changes in the pricing of innovative drugs without a national patent?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2582\" class=\"elementor-element elementor-element-19f6aad e-con-full e-flex e-con e-child\" data-id=\"19f6aad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2582\" class=\"elementor-element elementor-element-ed48083 e-flex e-con-boxed e-con e-child\" data-id=\"ed48083\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8cdcb52 elementor-widget elementor-widget-text-editor\" data-id=\"8cdcb52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Under the new Category 1, the price cap is now set at the lowest international price among the list of reference countries, even if the drug\u2019s patent is not registered in Brazil, thereby eliminating a long-standing barrier in the 2004 rule.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5b9b33f e-flex e-con-boxed e-con e-parent\" data-id=\"5b9b33f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ebb22a8 elementor-widget elementor-widget-text-editor\" data-id=\"ebb22a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3><strong>Life Sciences and Healthcare<\/strong><\/h3><p><span style=\"font-weight: 400;\">Fialdini Einsfeld Advogados provides regulatory and legal advisory services to companies in the pharmaceutical sector, including matters related to drug pricing and categorization before CMED. Our team is available to assist clients in analyzing the impacts of Resolution No. 3\/2025 and in developing regulatory strategies suited to the new regulatory framework.<\/span><\/p><h4><strong><br \/><\/strong>References<\/h4><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/medicamentos\/cmed\/legislacao\/RESOLUOCM_CMEDN3DE29DEDEZEMBRODE2025DOU.pdf\"><span style=\"font-weight: 400;\">CMED Resolution No. 3\/2025<\/span><\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Em 29 de maio de 2026, entrou em vigor a Resolu\u00e7\u00e3o n.\u00ba 3\/2025 da C\u00e2mara de Regula\u00e7\u00e3o do Mercado de Medicamentos (CMED), que reestrutura a metodologia de fixa\u00e7\u00e3o de pre\u00e7os de comercializa\u00e7\u00e3o de produtos farmac\u00eauticos no pa\u00eds. A norma substitui a antiga Resolu\u00e7\u00e3o n.\u00ba 2\/2004, atualizando as regras de categoriza\u00e7\u00e3o e os tetos de pre\u00e7os [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[32],"tags":[38,36],"ppma_author":[33,34],"class_list":["post-4919","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-direito-administrativo-e-regulatorio","tag-direito-sanitario"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Novo marco regulat\u00f3rio da CMED para precifica\u00e7\u00e3o de medicamentos: o que muda para o setor farmac\u00eautico - Fialdini Einsfeld Advogados<\/title>\n<meta name=\"description\" content=\"A Resolu\u00e7\u00e3o CMED n.\u00ba 3\/2025 entrou em vigor em maio de 2026 e atualiza as regras de precifica\u00e7\u00e3o de medicamentos no Brasil, incluindo novas categorias para biossimilares.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/feadv.com.br\/en\/new-cmed-regulatory-framework-for-drug-pricing-what-changes-for-the-pharmaceutical-sector\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novo marco regulat\u00f3rio da CMED para precifica\u00e7\u00e3o de medicamentos: o que muda para o setor farmac\u00eautico - 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