{"id":33734,"date":"2025-03-19T12:04:57","date_gmt":"2025-03-19T11:04:57","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33734"},"modified":"2025-06-16T16:33:14","modified_gmt":"2025-06-16T14:33:14","slug":"australia-new-procedures-for-recalls-prac-in-post-market-surveillance","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/03\/19\/australia-new-procedures-for-recalls-prac-in-post-market-surveillance\/","title":{"rendered":"Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h1 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 34; line-height: 1.16;\" data-fontsize=\"34\" data-lineheight=\"39.44px\">Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance<\/h1>\n<p>On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) introduced new guidance <strong>&#8216;Procedures for Recalls, Product Alerts and Product Corrections&#8217; (PRAC) <\/strong>for handling <strong>recalls<\/strong> and <strong>corrective actions<\/strong> on therapeutic products, including Medical Devices. This guide replaces the previous <strong>&#8216;Uniform Recall Procedure for Therapeutic Goods&#8217; (URPTG<\/strong>), simplifying and strengthening the post-marketing vigilance process for greater clarity and efficiency.<\/p>\n<p>The PRAC specifically targets <strong>foreign manufacturer sponsors,<\/strong> i.e. those who hold the marketing authorisation for the medical device through registration in the Australian Register of Therapeutic Goods (ARTG).<\/p>\n<p>Reporting adverse events relating to a medical device in the Australian market must comply with the <em>Therapeutic Goods<\/em> <em>Act<\/em> and the <em>Therapeutic Goods (Medical Devices) Regulations<\/em>. Post-market monitoring by the competent authorities aims to protect the health and safety of patients, healthcare professionals and users by reducing the likelihood of such events recurring.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">From URPTG to PRAC: What Changes?<\/h2>\n<p>One of the most significant changes concerns the <strong>classification of market actions<\/strong>: whereas the URPTG had eight separate categories, the PRAC has simplified them into <strong>four<\/strong>, making them clearer and easier to understand.<\/p>\n<ul>\n<li><strong>Recall<\/strong>: withdrawal of the product from the market for safety reasons.<\/li>\n<li><strong>Product Alert<\/strong>: a communication informing stakeholders of product safety updates.<\/li>\n<li><strong>Product Correction<\/strong>: modification or update of a product without withdrawal from the market.<\/li>\n<li><strong>Quarantine<\/strong>: temporary interruption of distribution pending further verification.<\/li>\n<\/ul>\n<p><strong>The main changes can be summarised as follows:<\/strong><\/p>\n<ul>\n<li><strong>Updated terminology<\/strong>: elimination of the distinction between &#8216;recall&#8217; and &#8216;non-recall&#8217; in favour of a single category called &#8216;market actions&#8217;.<\/li>\n<li><strong>Streamlined procedure<\/strong>: reduction of steps in the recall management process from 10 to 5.<\/li>\n<li><strong>Greater clarity<\/strong>: improved documentation with explanatory tables and diagrams.<\/li>\n<li><strong>Simplified<\/strong> <strong>definitions<\/strong>: simplified definitions of class and level of market shares.<\/li>\n<li><strong>New communication management processes<\/strong>: TGA now directly distributes sponsor-approved letters to customers. Furthermore, the TGA will no longer verify the accuracy of customer lists, making sponsors responsible for providing accurate information to avoid delays.<\/li>\n<li><strong>Removal of information on TGA legislative powers related to recalls<\/strong>: this information will be updated and placed as <strong>separate guidelines<\/strong> on the TGA website.<\/li>\n<\/ul>\n<p>In the event of a <strong>significant and imminent risk<\/strong> to life and public health, tampering or problems with radiopharmaceuticals, blood, tissue or clinical trials, sponsors must order customers to <strong>quarantine<\/strong> the affected products and notify the parties involved immediately, before contacting the TGA for further guidance.<\/p>\n<p>The PRAC retains the reforms introduced in the last version of the URPTG published in March 2024, which include more flexible reporting requirements, greater transparency and new, more user-friendly templates.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">The Five Phases of PRAC<\/h2>\n<ol>\n<li><strong>Problem assessment<\/strong>: collection of data on the products involved and risk analysis.<\/li>\n<li><strong>Notification to the TGA<\/strong>: sending the required documentation through the dedicated portal.<\/li>\n<li><strong>Review and approval<\/strong>: the TGA evaluates the case and sends an authorisation letter before sponsors can contact clients.<\/li>\n<li><strong>Initiation of Market Action<\/strong>: customer communications and response management.<\/li>\n<li><strong>Process closure<\/strong>: periodic reports and formal conclusion of the procedure.<\/li>\n<\/ol>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">Classification of Market Shares<\/h2>\n<p>Market shares are divided into three classes according to risk level:<\/p>\n<ul>\n<li><strong>Class I<\/strong>: critical situations requiring immediate action.<\/li>\n<li><strong>Class II<\/strong>: moderate risks requiring urgent corrective action.<\/li>\n<li><strong>Class III<\/strong>: problems with low-security impact.<\/li>\n<\/ul>\n<p>Depending on the mode of action, actions may include recalls, product corrections, alerts or quarantines (temporary suspensions).<\/p>\n<p>With this revision, the TGA aims to ensure greater speed and transparency in the recall of therapeutic products, improving public health protection and facilitating compliance for practitioners.<\/p>\n<p><strong>&gt;&gt;&gt; <\/strong>For all medical device regulatory compliance management processes in<strong> <a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">Australia<\/a><\/strong>, Thema experts are ready to offer the necessary support.<\/p>\n<p>SOURCE:<br \/>\n<a href=\"https:\/\/www.tga.gov.au\/how-we-regulate\/monitoring-safety-and-shortages\/procedure-recalls-product-alerts-and-product-corrections-prac\">https:\/\/www.tga.gov.au\/how-we-regulate\/monitoring-safety-and-shortages\/procedure-recalls-product-alerts-and-product-corrections-prac<\/a><\/p>\n<p><em>03\/19\/2025<\/em><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":33746,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[1656],"class_list":["post-33734","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-ivdr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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