{"id":4900,"date":"2026-08-17T10:35:48","date_gmt":"2026-08-17T13:35:48","guid":{"rendered":"https:\/\/feadv.com.br\/?p=4900"},"modified":"2026-08-17T10:35:48","modified_gmt":"2026-08-17T13:35:48","slug":"ppclin-of-the-ministry-of-health-structures-brazil-as-a-strategic-hub-for-clinical-research","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/ppclin-o-ministerio-da-saude-estrutura-o-brasil-como-polo-estrategico-de-pesquisa-clinica\/","title":{"rendered":"PPClin: the Ministry of Health establishes Brazil as a strategic hub for clinical research"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"4900\" class=\"elementor elementor-4900\" 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 8, 2026, the Ministry of Health published the Ordinance establishing the National Clinical Research Program (PPClin), designed to modernize the regulatory procedures for health scientific trials in Brazil.<\/span><\/p><p><span style=\"font-weight: 400;\">The objective of the government program is to increase the country's attractiveness to the international biotechnology industry, boosting the ecosystem for the development of drugs, immunizing agents, and medical devices.<\/span><\/p><p>\u00a0<\/p><h3><strong>What is PPClin and what are its objectives<\/strong><\/h3><p><span style=\"font-weight: 400;\">PPClin functions as an integration platform among hospital centers, universities, pharmaceutical laboratories, and health and ethical regulatory bodies.<\/span><\/p><p><span style=\"font-weight: 400;\">The program guidelines prioritize the streamlining of trial approval workflows, encouraging cooperation between the National Research Ethics Body (Inaep), ANVISA, and the regional coordination offices for clinical studies.<\/span><\/p><p><span style=\"font-weight: 400;\">In this way, the goal is to reduce the average authorization time for new trials, which currently represents an obstacle to the country's competitiveness in the global health innovation market.<\/span><\/p><p>\u00a0<\/p><h3><strong>Execution mechanisms and selection criteria<\/strong><\/h3><p><span style=\"font-weight: 400;\">The promotion of research will be enabled through public calls, notices, and cooperation between entities in the innovation sector. Finep and CNPq will act in the structuring and capital support for the approved projects.<\/span><\/p><p><span style=\"font-weight: 400;\">The eligibility criteria for centers and studies encompass:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Alignment of research with the strategic demands of the SUS;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Robustness of the installed infrastructure and analytical capacity of the centers;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Prior experience of the team and investigators in conducting trials; and<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Integrated operation of a permanent local Research Ethics Committee (REC).<\/span><\/span><p>\u00a0<\/p><\/li><\/ul><h3><strong>The economic potential of clinical research in the country<\/strong><\/h3><p><span style=\"font-weight: 400;\">Data from Interfarma show that the clinical trials sector generates approximately R$ 6.3 billion annually in Brazil. Despite these impressive figures, it is estimated that the national infrastructure operates well below capacity.<\/span><\/p><p><span style=\"font-weight: 400;\">The federal program aims to fill this gap, generating direct therapeutic benefits for local patients and putting Brazil on the map for cutting-edge clinical trials of highly complex drugs.<\/span><\/p><p>\u00a0<\/p><h3><strong>What changes for sponsors and investigators<\/strong><\/h3><p><span style=\"font-weight: 400;\">Although the program does not summarily alter ethical and sanitary legislation, it establishes public commitments to administrative simplification and acceleration in the regulatory flow of protocol evaluation.<\/span><\/p><p><span style=\"font-weight: 400;\">International sponsors must monitor the publication of the new PPClin calls for proposals to structure local partnerships with the certified centers of excellence.<\/span><\/p><p>\u00a0<\/p><h3><strong>PPClin and clinical research in Brazil: what companies and investigators need to know<\/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\"> Which organizations will provide financial and funding support for the PPClin projects?  <\/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 execution and funding of the program will rely on the support and resources of Finep (Financier of Studies and Projects) and CNPq.<\/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\"> Did the regulations for the ethical approval of trials change with PPClin?  <\/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;\">Current sanitary legal requirements and rules have not changed. The program proposes administrative harmonization and optimization of internal operational flows between ANVISA and the ethics system, without relaxing methodological rigor.<\/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 is the main bottleneck that the government program aims to solve?  <\/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;\">The PPClin tackles excess bureaucracy and the approval time for studies of new molecules in Brazilian territory, bringing national institutions closer to international standards of agility.<\/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 acts in regulatory and legal advisory for clinical research sponsors, research centers, and investigators, providing support from the structuring of study protocols to the conduct of processes before ANVISA and ethics committees. Our team monitors the sector's regulatory updates to offer specialized support to health innovation initiatives in Brazil.<\/span><\/p><h4><strong><br \/>References<\/strong><\/h4><p><a href=\"https:\/\/futurodasaude.com.br\/pesquisa-clinica-novo-programa\/\"><span style=\"font-weight: 400;\">Ordinance of the Ministry of Health \u2013 National Clinical Research Program (PPClin)<\/span><\/a><\/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 8 de maio de 2026, o Minist\u00e9rio da Sa\u00fade publicou a Portaria que institui o Programa Nacional de Pesquisa Cl\u00ednica (PPClin), desenhado para modernizar os tr\u00e2mites regulat\u00f3rios de testes cient\u00edficos de sa\u00fade no Brasil. O objetivo do programa governamental \u00e9 elevar a atratividade do pa\u00eds perante a ind\u00fastria biotecnol\u00f3gica internacional, dinamizando o ecossistema de [&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":[35,36],"ppma_author":[33,34],"class_list":["post-4900","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-direito-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>PPClin: o Minist\u00e9rio da Sa\u00fade estrutura o Brasil como polo estrat\u00e9gico de pesquisa cl\u00ednica - Fialdini Einsfeld Advogados<\/title>\n<meta name=\"description\" content=\"A ANVISA publicou a Nota T\u00e9cnica n.\u00ba 60\/2026, que consolida o entendimento regulat\u00f3rio sobre a intercambialidade entre medicamentos biol\u00f3gicos e 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\/ppclin-of-the-ministry-of-health-structures-brazil-as-a-strategic-hub-for-clinical-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PPClin: o Minist\u00e9rio da Sa\u00fade estrutura o Brasil como polo estrat\u00e9gico de pesquisa cl\u00ednica - 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