{"id":6054,"date":"2025-12-22T21:44:59","date_gmt":"2025-12-22T21:44:59","guid":{"rendered":"https:\/\/we-search.co.za\/articles\/?p=6054"},"modified":"2025-12-22T21:45:48","modified_gmt":"2025-12-22T21:45:48","slug":"87998-sahpra-south-african-health-product-regulatory-authority","status":"publish","type":"post","link":"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/","title":{"rendered":"South African Health Products Regulatory Authority (SAHPRA)"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_64 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #ffffff;color:#ffffff\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #ffffff;color:#ffffff\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/#Who_is_SAHPRA_South_African_Health_Products_Regulatory_Authority_April_2026\" title=\"Who is SAHPRA (South African Health Products Regulatory Authority) April 2026.\">Who is SAHPRA (South African Health Products Regulatory Authority) April 2026.<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/#SAHPRA_Management_and_Board\" title=\"SAHPRA Management and Board\">SAHPRA Management and Board<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/#What_does_SAHPRA_do\" title=\"What does SAHPRA do?\">What does SAHPRA do?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/#How_is_SAHPRA_Funded\" title=\"How is SAHPRA Funded?\">How is SAHPRA Funded?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/#Backlogs\" title=\"Backlogs\">Backlogs<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/#SAHPRAs_Operational_Model\" title=\"SAHPRA\u2019s Operational Model\">SAHPRA\u2019s Operational Model<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Who_is_SAHPRA_South_African_Health_Products_Regulatory_Authority_April_2026\"><\/span>Who is SAHPRA (South African Health Products Regulatory Authority) April 2026.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<blockquote><p>SAHPRA is the South African Health Products Regulatory Authority.<\/p><\/blockquote>\n<p>The South African government established it as a Section 3A public institution to supervise the regulation of health goods such as medications, medical equipment, in-vitro diagnostic tests and devices, and radiation emitting items and devices used in health care and industry.<\/p>\n<p>The Medicines Control Council (MCC) and the Directorate of Radiation Control have been replaced by SAHPRA (DRC).<\/p>\n<h2><span class=\"ez-toc-section\" id=\"SAHPRA_Management_and_Board\"><\/span>SAHPRA Management and Board<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>SAHPRA is governed by a Board of Directors chosen by the Minister of Health.<\/p>\n<p>The Board appoints the Chief Executive Officer (CEO) after consulting with the Minister of Health.<\/p>\n<p>Several top management roles, including Chief Financial Officer, Director of Information Technology, and Company Secretary, have been filled.<\/p>\n<p>Others, such as the Chief Regulatory Officer and top managers in each division, are being filled for the first time.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_does_SAHPRA_do\"><\/span>What does SAHPRA do?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Medicines and Related Substances Act of 1965 requires SAHPRA to regulate all health goods in South Africa and their usage.<\/p>\n<p>The duty of supervising radiation control in South Africa has also been transferred to SAHPRA.<\/p>\n<p>The Hazardous Substances Act governs this role, which is designed to safeguard the public from radiation used in both medical and industrial contexts.<\/p>\n<p>SAHPRA&#8217;s job is to protect and promote public health by ensuring that all medications and medical devices accessible and utilized in the nation are safe, effective, and of high quality.<\/p>\n<p>All functions are active now, although some are new, such as medical device registration and vigilance, as well as oversight of clinical trials for medical devices and in-vitro diagnostics, and the entire spectrum of operations will only be implemented over the next few years.<\/p>\n<p><strong>SAHPRA services in a nutshell.<\/strong><\/p>\n<ul>\n<li>Medicines<\/li>\n<li>Complementary Medicines<\/li>\n<li>Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)<\/li>\n<li>Radiation Controlare safe, effective and of good quality and in the interest of the public throughout their life cycle.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"How_is_SAHPRA_Funded\"><\/span>How is SAHPRA Funded?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Through the National Department of Health budget, SAHPRA receives a portion of its funding from the national treasury.<\/p>\n<p>The rest of SAHPRA&#8217;s funding comes from fees for services performed in the execution of its mandates.<\/p>\n<p>The entity may also accept donations if the National Treasury Regulations are followed.<\/p>\n<p>The majority of SAHPRA&#8217;s funds are projected to come from fees over time.<\/p>\n<p>The goal is to provide better, quicker services and therefore justify higher rates.<\/p>\n<p>Several functions are now given for free, however this will change in the future.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Backlogs\"><\/span>Backlogs<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>SAHPRA has pledged to resolving a backlog of medication applications, which includes both pre-registration and post-registration amendment applications, within two years.<\/p>\n<p><strong>The backlog clearance strategy comprises three pillars:<\/strong><\/p>\n<ol>\n<li>reducing the number of applications that require evaluation.<\/li>\n<li>segmenting and prioritising applications on the basis of public health need, and<\/li>\n<li>implementing new models for evaluation that recognise work done by other national regulatory agencies.<\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"SAHPRAs_Operational_Model\"><\/span>SAHPRA\u2019s Operational Model<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The initial members of SAHPRA came from several divisions under the National Department of Health.<\/p>\n<p>SAHPRA has acquired temporary office space at the CSIR Pretoria Campus.<\/p>\n<p>Plans are in the works to ensure a long-term solution.<\/p>\n<ul>\n<li><strong>Programme 1<\/strong> Corporate Services.<\/li>\n<li><strong>Programme 2<\/strong> Health Product Authorisation.<\/li>\n<li><strong>Programme 3<\/strong> Inspectorate and Regulatory Compliance.<\/li>\n<li><strong>Programme 4<\/strong> Evaluation for Registration.<\/li>\n<li><strong>Programme 5<\/strong> Medical Devices and Radiation Control.<\/li>\n<\/ul>\n<p>For more information on SAHPRA, please visit their website on the following link <a href=\"https:\/\/www.sahpra.org.za\/\" target=\"_blank\" rel=\"noopener\">www.sahpra.org.za <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Who is SAHPRA (South African Health Products Regulatory Authority) . SAHPRA is the South African Health Products Regulatory Authority. The South African government established it&#8230;<\/p>\n","protected":false},"author":1,"featured_media":6057,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v17.8 (Yoast SEO v20.2.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>SAHPRA | South African Health Products Regulatory Authority<\/title>\n<meta name=\"description\" content=\"SAHPRA is a division of the National Department of Health that was established by the South African government - WeSearchSA\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/we-search.co.za\/articles\/news\/87998-sahpra-south-african-health-product-regulatory-authority\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"South African Health Products Regulatory Authority (SAHPRA)\" \/>\n<meta property=\"og:description\" content=\"SAHPRA is a division of the National Department of Health that was established by the South African government - 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