Presentation: The Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) - What you need to know

Background

After receiving feedback about the current recalls process from various stakeholders, the TGA established a recall reforms program. In 2023, we published a discussion paper and consulted widely on potential changes to how we undertake product recalls in Australia. Many of the discussion paper’s proposals were incorporated into a new version of the TGA’s guidance, the Uniform Recall Procedure for Therapeutic Goods (URPTG) in March 2024. Improvements will be made to our IT systems to increase efficiency and implement new terminology.

This new terminology replaces the confusing categories of ‘recall actions’ and ‘non-recall actions’ with one overarching category called ‘market actions'. These changes supported our decision to rename our procedure document from the URPTG to the Procedure for Recalls, Product Alerts and Product Corrections (PRAC). Written to be straightforward, jargon-free and compatible with modern browsers, the PRAC represents a significant and positive change in the recalls process.

This webinar will ensure that the transition from the URPTG to the PRAC is seamless, addressing stakeholder concerns and featuring extensive side-by-side-comparisons between the two documents.

The webinar will explain where the process has changed, and what our stakeholders can expect to stay the same.

Speakers

Jack Casey, Project Officer (Recall Reforms Program), Manufacturing Quality Branch, TGA

Craig Davies, Australian Recall Coordinator, Manufacturing Quality Branch, TGA

Nathan Coleman, Project Manager (Recall Reforms Program), Manufacturing Quality Branch, TGA

Slides

Webinar recording