{"id":1200,"date":"2026-10-16T08:32:46","date_gmt":"2026-10-16T11:32:46","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1200"},"modified":"2026-10-16T08:32:46","modified_gmt":"2026-10-16T11:32:46","slug":"anvisa-amends-resolutions-for-ba-be-and-biowaiver-criteria-removing-the-requirement-for-vasoconstrictor-skin-blanching-studies-for-semisolid-topical-corticosteroids","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/10\/16\/anvisa-amends-resolutions-for-ba-be-and-biowaiver-criteria-removing-the-requirement-for-vasoconstrictor-skin-blanching-studies-for-semisolid-topical-corticosteroids\/","title":{"rendered":"ANVISA amends resolutions for BA\/BE and Biowaiver criteria removing the requirement for Vasoconstrictor (Skin Blanching) studies for Semisolid Topical Corticosteroids"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On October 5, 2026, ANVISA published in the Federal Official Gazette (DOU) Resolution RDC No. 1,044 of October 2, 2026, which amends Resolution RDC No. 742\/2022, which provides for the requirements for Bioavailability\/Bioequivalence (BA\/BE) studies, and Resolution RDC No. 749\/2022, which establishes the criteria for Biowaiver, to remove the mandatory vasoconstriction (or skin blanching) study for semisolid topical corticosteroids. This Resolution came into force on the date of publication.<\/span><\/p>\n<p><!--more--><\/p>\n<h3>What changes<\/h3>\n<p><span style=\"font-weight: 400;\">RDC 1,044\/2026 introduces the following changes:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Revocation of Art. 111 of RDC 742\/2022. The article set a schedule for authorized semisolid medicinal products containing corticosteroids to submit the required pharmacodynamic studies, considering the drug substance present in the formulation. The article also provided for withdrawal of the marketing authorization if the studies were not provided by the deadline.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Amendment of Art. 7, paragraph 3, item I of RDC 749\/2022. Semisolid topical formulations containing corticosteroids are no longer listed among the exceptions to the biowaiver for topical dosage forms, and the provision now lists only otic and ophthalmic suspensions.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In practice, these products will be able to request the biowaiver provided for in Art. 7, item VII of RDC 749\/2022, as long as they meet the criteria of that regulation, with submission of in vitro performance data and references on the permeability of the product, in accordance with Art. 14 of the aforementioned regulation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It should be noted, however, that RDC 1,044\/2026 does not change Art. 75 of RDC 742\/2022, which still states that the pharmacodynamic study for dermatological topical corticosteroids should follow a specific normative act (IN 327\/2024).<\/span><\/p>\n<h3>Why ANVISA made this change<\/h3>\n<p><span style=\"font-weight: 400;\">During the implementation of the regulation, several technical difficulties were reported in conducting the required pharmacodynamic studies. As the methodology was new in Brazil, there were no qualified laboratories to conduct the test, and the necessary technical expertise had not yet been fully established: the few centers that offer the test are insufficient for the number of products to be assessed.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In this context, pharmaceutical industry associations have continuously monitored the matter since the publication of RDC No. 742\/2022, engaging with ANVISA through meetings to highlight the challenges associated with implementing the regulation and the potential impact on the market availability of these products.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Furthermore, since the issuance of RDC No. 742\/2022, ANVISA has observed no changes in the pharmacovigilance profile for these products, whether related to lack of efficacy or other adverse events.<\/span><\/p>\n<h3>Global convergence<\/h3>\n<p><span style=\"font-weight: 400;\">The vasoconstrictor study remains provided for by reference authorities such as the US FDA and EMA. However, these authorities adopt broader and more flexible regulatory approaches, based on the integrated use of multiple sources of evidence to demonstrate therapeutic equivalence. Under these approaches, pharmacodynamic studies remain available as a regulatory tool, but are no longer the only option to demonstrate product equivalence.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The Brazilian authority&#8217;s decision rests on the available technical capacity and on pharmacovigilance data, and it deserves careful consideration in projects that will also be submitted in other markets.<\/span><\/p>\n<h3>Practical impact<\/h3>\n<ul>\n<li><span style=\"font-weight: 400;\">Marketing authorization holders (MAHs) of semisolid topical corticosteroids: the need to submit the vasoconstriction study has been removed, and the risk of MA withdrawal under Art. 111 of RDC 742\/2022 is no longer foreseen. Accordingly, companies should assess their products to confirm their eligibility for the biowaiver, as per RDC 749\/2022.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">New applications: development of these products can focus on pharmaceutical equivalence and in vitro comparability of the formulation, as long as the biowaiver requirements, in compliance with RDC 749\/2022, are met.<\/span><\/li>\n<\/ul>\n<h3>How Vita can help<\/h3>\n<p><span style=\"font-weight: 400;\">Vita supports companies in defining marketing authorization and biowaiver strategies for all classes of medicinal products, including topical corticosteroids, from gap analysis to product eligibility, and in preparing and submitting dossiers to ANVISA.<\/span><\/p>\n","protected":false},"author":3,"featured_media":1201,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22],"class_list":["post-1200","noticias","type-noticias","status-publish","has-post-thumbnail","hentry","categorias-brasil-anvisa"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ANVISA amends resolutions for BA\/BE and Biowaiver criteria removing the requirement for Vasoconstrictor (Skin Blanching) studies for Semisolid Topical Corticosteroids - Vita<\/title>\n<meta name=\"description\" content=\"On October 5, 2026, ANVISA published in the Federal Official Gazette (DOU) Resolution RDC No. 1,044 of October 2, 2026, which amends Resolution RDC No. 742\/2022, which provides for the requirements for Bioavailability\/Bioequivalence (BA\/BE) studies, and Resolution RDC No. 749\/2022, which establishes the criteria for Biowaiver, to remove the mandatory vasoconstriction (or skin blanching) study for semisolid topical corticosteroids. 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