{"id":5069,"date":"2026-10-06T10:00:07","date_gmt":"2026-10-06T13:00:07","guid":{"rendered":"https:\/\/feadv.com.br\/?p=5069"},"modified":"2026-10-06T10:55:58","modified_gmt":"2026-10-06T13:55:58","slug":"regulatory-sandbox-anvisa-seeks-to-reconcile-technological-innovation-and-risk-management-in-the-health-sector","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/sandbox-regulatorio-anvisa-busca-conciliar-inovacao-tecnologica-e-gestao-de-riscos-no-setor-de-saude\/","title":{"rendered":"Regulatory Sandbox: Anvisa seeks to reconcile technological innovation and risk management in the healthcare sector"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5069\" class=\"elementor elementor-5069\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8eaea9a e-flex e-con-boxed e-con e-parent\" data-id=\"8eaea9a\" 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-3da38cd elementor-widget elementor-widget-text-editor\" data-id=\"3da38cd\" 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 National Sanitary Surveillance Agency (Anvisa) is advancing in the drafting of a resolution proposal aimed at regulating the Experimental Regulatory Environment, known as the Regulatory Sandbox, in the Brazilian health sector.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Based on the Legal Framework for Startups (Supplementary Law No. 182\/2021\u00b9)<\/span><span style=\"font-weight: 400;\">, This mechanism allows companies and research centers to test innovative business models, technologies, and products under special conditions and under the direct supervision of the health authority.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The initiative marks an evolution in the agency's approach, which seeks to reconcile the promotion of scientific development and artificial intelligence with the unrestricted preservation of public health safety.<\/span><\/p>\n<h3><b><br>The purpose of the new general resolution of Anvisa<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">The issue has been discussed internally by the agency and will be submitted to the deliberation of the Collegiate Board in the coming months\u00b2.<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to the municipal director-president, Leandro Safatle, the general standard aims to establish clear criteria for the admission of projects, monitoring parameters and rules regarding the responsibilities of the participants.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The central objective is to apply regulatory flexibility in a manner proportional to the risks involved, ensuring that the public interest and the protection of the collective remain at the center of decisions.<\/span><\/p>\n<h3><b><br>Practical applications: biotechnology, artificial intelligence and precedents<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">In the field of human health, the sandbox model opens up expressive opportunities for different industrial and technological sectors:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Medical devices and artificial intelligence: <\/b><span style=\"font-weight: 400;\">validation of diagnostic software (SaMD) and predictive tools applied to clinical practice.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>New assets and advanced therapies:<\/b><span style=\"font-weight: 400;\"> the conduct of controlled tests of raw materials and therapeutic formulations before the final phase of commercial registration.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Previous history of medicinal cannabis: <\/b><span style=\"font-weight: 400;\">DRC No. 1.014\/2026\u00b3<\/span><span style=\"font-weight: 400;\">&nbsp;It has already established an experimental model for up to five years for the cultivation and processing of inputs, serving as a regulatory laboratory for the future general standard.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\"><br>As observed by Daniela Marreco, director of Anvisa, by making it feasible to produce regulated inputs and products intended for specific patients on a non-industrial and small-scale basis, the model contributes to improving the sanitary quality of the products effectively used by the population, in addition to allowing for the continuity of therapeutic treatment\u2074<\/span><span style=\"font-weight: 400;\">. The supervised experimentation thus generates solid technical evidence to support future regulatory decisions in a safe and transparent manner.<br><br><\/span><\/p>\n<p><\/p>\n<h3><b>Governance challenges and continuous monitoring<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Unlike other economic sectors, such as finance or telecommunications, projects in the healthcare sector involve direct risks to the physical integrity and life of patients.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For this reason, the successful implementation of the Regulatory Sandbox at Anvisa will require:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Strict eligibility criteria and precise delimitation of the hypotheses for temporary exemption from ordinary requirements.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Agile mechanisms for reporting adverse events and the preventive cancellation of experimental authorizations in case of unforeseen risk.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Clear definition of contractual governance and allocation of responsibilities between technology partners, investors, and manufacturers.<br><br><\/li>\n<\/ul>\n<p>While the final resolution is awaited, regulated agents should closely monitor the discussions to identify windows of opportunity in research and development.<\/p>\n<h2><b><br>Understanding the Regulatory Sandbox in Health<\/b><\/h2>\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-a5ce9a4 e-flex e-con-boxed e-con e-parent\" data-id=\"a5ce9a4\" 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-c08f1cf elementor-widget elementor-widget-n-accordion\" data-id=\"c08f1cf\" 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-2010\" 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-2010\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What characterizes the Regulatory Sandbox in the healthcare sector? <\/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-2010\" class=\"elementor-element elementor-element-6f3abcc e-con-full e-flex e-con e-child\" data-id=\"6f3abcc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2010\" class=\"elementor-element elementor-element-2ed39ab e-flex e-con-boxed e-con e-child\" data-id=\"2ed39ab\" 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-e42e886 elementor-widget elementor-widget-text-editor\" data-id=\"e42e886\" 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;\">It is a temporary and controlled authorization issued by Anvisa for companies to develop and test innovative technologies, drugs, or models, with the flexibility of certain regulatory requirements.<\/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-2011\" 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-2011\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Does participation in the Sandbox guarantee the granting of a final registration? <\/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-2011\" class=\"elementor-element elementor-element-32d7350 e-con-full e-flex e-con e-child\" data-id=\"32d7350\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2011\" class=\"elementor-element elementor-element-83f325e e-flex e-con-boxed e-con e-child\" data-id=\"83f325e\" 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-ff2116a elementor-widget elementor-widget-text-editor\" data-id=\"ff2116a\" 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;\">No. The experimental environment has a transitory nature and generates data. Ordinary commercial registration will depend on compliance with the requirements of effectiveness and safety required by sanitary legislation.<\/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-2012\" 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-2012\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which areas of healthcare will benefit most from the new 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-2012\" class=\"elementor-element elementor-element-6820386 e-con-full e-flex e-con e-child\" data-id=\"6820386\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2012\" class=\"elementor-element elementor-element-50c40db e-flex e-con-boxed e-con e-child\" data-id=\"50c40db\" 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-5ae936c elementor-widget elementor-widget-text-editor\" data-id=\"5ae936c\" 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 segment of digital medical devices with artificial intelligence, innovative biotechnological products and new pharmaceutical formulation routes stand out.<\/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-af73d83 e-flex e-con-boxed e-con e-parent\" data-id=\"af73d83\" 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-47e9fda elementor-widget elementor-widget-text-editor\" data-id=\"47e9fda\" 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><b>Life Sciences and Healthcare<\/b><\/h3><p><span style=\"font-weight: 400;\">The Life Sciences and Healthcare practice of <\/span><b>Fialdini Einsfeld Advogados (FEADV) <\/b><span style=\"font-weight: 400;\">Assists pharmaceutical companies, healthtechs and research centers in the formulation of innovative projects and in dialogue with health authorities. Our team monitors the evolution of experimental regulatory milestones to structure partnerships, manage compliance risks and enable new business models in healthcare.<\/span><\/p><p>\u00a0<\/p><h4><b>References<\/b><\/h4><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.planalto.gov.br\/ccivil_03\/leis\/lcp\/lcp182.htm\"><span style=\"font-weight: 400;\">BRAZIL. Complementary Law No. 182 of June 1st, 2021. Establishes the legal framework for startups and innovative entrepreneurship<\/span><\/a><\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"text-decoration: underline;\"><a href=\"https:\/\/futurodasaude.com.br\/anvisa-prepara-norma-sandbox-regulatorio\/\"><span style=\"font-weight: 400;\">KROLL, Rebeca. Anvisa advances a general standard for the use of regulatory sandboxes. Futuro da Sa\u00fade, 4 Feb. 2026<\/span><\/a><\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"text-decoration: underline;\"><a href=\"https:\/\/anvisalegis.datalegis.net\/action\/ActionDatalegis.php?acao=abrirTextoAto&amp;tipo=RDC&amp;numeroAto=00001014&amp;seqAto=000&amp;valorAno=2026&amp;orgao=RDC\/DC\/ANVISA\/MS&amp;codTipo=&amp;desItem=&amp;desItemFim=&amp;cod_menu=9434&amp;cod_modulo=310&amp;pesquisa=true\"><span style=\"font-weight: 400;\">NATIONAL AGENCY OF HEALTH SURVEILLANCE (ANVISA). Resolution of the Colegiated Board RDC No. 1.014, of 2026. It provides for the creation of a Regulatory Sandbox for activities related to medicinal cannabis.<\/span><\/a><\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"text-decoration: underline;\"><a href=\"https:\/\/futurodasaude.com.br\/sandbox-regulatorio-anvisa-e-ans\/\"><span style=\"font-weight: 400;\">MACHADO, Rafael. Anvisa takes new steps using a regulatory sandbox, while the issue stagnates in the ANS. Futuro da Sa\u00fade, 4 Feb. 2026<\/span><\/a><\/span><\/li><\/ol>\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>The future resolution of the Anvisa for the Regulatory Sandbox will create parameters for testing health innovations with legal certainty and risk control.<\/p>","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":[36,49],"ppma_author":[33,28],"class_list":["post-5069","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-direito-sanitario","tag-inovacao-em-saude"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sandbox regulat\u00f3rio: Anvisa busca conciliar inova\u00e7\u00e3o tecnol\u00f3gica e gest\u00e3o de riscos no setor de sa\u00fade - 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