{"id":1202,"date":"2026-10-20T09:38:08","date_gmt":"2026-10-20T12:38:08","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1202"},"modified":"2026-10-20T09:38:08","modified_gmt":"2026-10-20T12:38:08","slug":"anvisa-publishes-qa-on-the-new-herbal-medicines-framework-and-clarifies-the-adaptation-of-authorized-products","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/10\/20\/anvisa-publishes-qa-on-the-new-herbal-medicines-framework-and-clarifies-the-adaptation-of-authorized-products\/","title":{"rendered":"ANVISA Publishes Q&#038;A on the New Herbal Medicines Framework and Clarifies the Adaptation of Authorized Products"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On October 13, 2026, ANVISA released the Questions and Answers (Q&amp;A) document on the new rules for herbal medicines, in its first edition dated October 2. The material compiles questions received through ANVISA&#8217;s service channels, at seminars and during the technical assessment of applications, and sets out the regulator&#8217;s understanding of Resolution RDC No. 1,004\/2025, Normative Instructions (INs) No. 410, 411 and 412\/2025 and Guide No. 85\/2025, in force since February 2026.<\/span><\/p>\n<p><!--more--><\/p>\n<h2>Legacy products<\/h2>\n<p><span style=\"font-weight: 400;\">A large part of the questions addresses medicines already authorized under RDC No. 26\/2014, referred to as legacy products. ANVISA clarifies that these products remain valid and do not need to adopt the new concepts of specification, manufacturing and quality control immediately. Adaptation is voluntary, unless a post-approval change requires it. Companies that choose to adapt have dedicated application subjects to update the herbal raw material or finished product specification (codes 12425 and 12426).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">There is one relevant exception regarding the package leaflet and labeling. Even without changing the approved specification, the type of extract declared must follow the current concepts: when the marker is analytical, for example, the extract is classified as \u201cothers\u201d and not as quantified, regardless of the class previously authorized.<\/span><\/p>\n<h2>Mandatory adaptations<\/h2>\n<p><span style=\"font-weight: 400;\">For herbal medicines already authorized, the Q&amp;A consolidates three obligations:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">By 12\/16\/2026: update of the pesticide residue analysis list under IN No. 411\/2025, applicable to all herbal medicines (subject 12446).<\/span><\/li>\n<li><span style=\"font-weight: 400;\">By 12\/22\/2026: notification of package leaflet changes (subject 12415) and labeling changes (subject 12416) by herbal medicinal products (HMP) and traditional herbal medicinal products (THMP), limited to what Arts. 41 and 42 allow: the new nomenclature \u201ctraditional herbal medicinal product\u201d, in portuguese \u201c<\/span><i><span style=\"font-weight: 400;\">medicamento tradicional fitoter\u00e1pico<\/span><\/i><span style=\"font-weight: 400;\">\u201d, adjustment of the extract information and inclusion, on the secondary packaging, of the statement on the concepts of RDC No. 26\/2014.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Products that, after the publication of RDC No. 26\/2014, did not qualify as traditional herbal products (THP) and did not have complete safety and efficacy studies to qualify as HMPs must submit nonclinical and clinical studies by the first renewal following the publication of RDC No. 1,004\/2025. Note that this point has raised many questions: this obligation applies only to companies that had not yet complied with the previous regulation. If your company\u2019s product was authorized as an herbal medicinal product or a traditional herbal product in accordance with the requirements of RDC 26\/2014, there is no need to submit additional safety and efficacy data (unless a post-approval change requires it).<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Changes to the package leaflet and labeling must be available to consumers within 180 days, for products with six or more batches produced in the 12 months prior to notification, or within 365 days for the others.<\/span><\/p>\n<h2>Details of the changes introduced by the new regulatory framework<\/h2>\n<p><span style=\"font-weight: 400;\">The document also details technical criteria applicable to new applications. Extracts are classified as standardized, quantified and others, following the model adopted by the European Medicines Agency (EMA). New standardized extracts normally require clinical evidence of efficacy and safety.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It now becomes necessary to demonstrate equivalence between different suppliers of the herbal active pharmaceutical ingredient (herbal API). The new framework uses the same critical parameters adopted in the European Union, and demonstrating the similarity of the chromatographic profile or markers alone is not sufficient to prove this equivalence.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Simplified marketing authorization must fully follow the monographs of the EMA Committee on Herbal Medicinal Products (HMPC), which explains why IN No. 412\/2025 lists only five species: it complements more than 170 European monographs. The document clarifies that the rationale adopted for the monographs of Brazilian species is the same as that recommended by the EMA: species with a traditional use monograph (currently, the five species on the list) may be authorized through simplified marketing authorization as traditional herbal medicinal products. If a well-established use monograph is adopted for a Brazilian species, it may be authorized as an herbal medicinal product.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A nitrosamine risk assessment becomes mandatory for new marketing authorization applications and notifications. For legacy products, ANVISA recommends carrying it out as soon as possible, since it may be requested in post-approval changes.<\/span><\/p>\n<h2>How to prepare<\/h2>\n<p><span style=\"font-weight: 400;\">In practice, the Q&amp;A calls for a product-by-product review. Each medicine needs to be classified (legacy, HMP, THMP, simplified marketing authorization or notification), the extract type must be confirmed and changes to the package leaflet and labeling should be planned well in advance, since the December deadlines leave little room for corrections. The choice between voluntarily adapting the specification and waiting for a post-approval change also deserves case-by-case analysis. It is also worth following Guide No. 85\/2025, whose second version is being finalized and which ANVISA strongly recommends reading.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vita supports companies throughout this process, from portfolio mapping and extract classification to package leaflet and labeling review and the definition of the adaptation strategy.<\/span><\/p>\n<p><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/setorregulado\/regularizacao\/medicamentos\/fitoterapicos-dinamizados-e-especificos\/informes\/fitoterapicos\/p-r-rdc-1004-2025.pdf\/@@display-file\/file\"><span style=\"font-weight: 400;\">Access the full document.<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":1203,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22],"class_list":["post-1202","noticias","type-noticias","status-publish","has-post-thumbnail","hentry","categorias-brasil-anvisa"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - 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