Recall reforms update and new procedure
Update: The final package of TGA recall reforms will be implemented on 5 March 2025, alongside the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC). The URPTG will officially be replaced by the PRAC, and sponsors will be expected to follow the new guidance and market action terminology from this date.
We also hosted a webinar 20 February 2025, which highlighted the differences between the URPTG and the PRAC and answered stakeholder questions. The presentation slides are available now and the video recording will be available shortly.
The TGA is providing sponsors with advance notice of the final package of the recall reforms which will be implemented in early March 2025. This includes providing a preview of Australia’s new recall procedure which will be known as the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
Sponsors will continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until early March 2025, at which time the URPTG will be replaced by the PRAC. We will advise the precise implementation date closer to this time.
The PRAC addresses stakeholder feedback from our 2023 discussion paper, as part of the broader consultation on potential changes and improvements to the management of product recalls in Australia.
The PRAC will:
- enhance the transparency, communication and timeliness of recalls, alerts and corrections
- introduce new market action terminology, reducing the categories from 8 to 4, as illustrated below
- halve the number of steps in the process from 10 to 5 but will not require any major changes to how sponsors approach the process
- feature fewer pages with less repetition, clearer information and instructions.
One of the most requested changes was to update the recall terminology, removing the sometimes confusing categories of ‘recall’ and ‘non-recall’ actions, and replacing them with one category called ‘market actions’.
This diagram illustrates the transition between current and new reporting processes for product-related actions.
It shows the simplification of the reporting process, with some current categories being consolidated and others being removed from TGA reporting requirements.
The diagram shows two main columns: "Current Process" on the left and "New Process" on the right.
The Current Process is divided into two sections:
- "Recall Actions" (shown in orange) includes:
- Recall
- Product Defect Alert
- Product Defect Correction
- Hazard Alert
- "Non-recall Actions" (shown in yellow) includes:
- Quarantine
- Safety Alert
- Product Notification
- Product Withdrawal
The New Process shows:
"Market Actions" (shown in green) which includes:
- Recall
- Product Alert
- Product Correction
- Quarantine
The diagram uses arrows to show how the current categories will map to new categories:
- Current "Recall" maps to new "Recall"
- "Product Defect Alert" maps to "Product Alert"
- "Product Defect Correction" maps to "Product Correction"
- "Hazard Alert" maps to "Product Alert"
- Current "Quarantine" maps to new "Quarantine"
- "Product Notification" and "Product Withdrawal" map to a grey box labelled "No longer reported to the TGA"
We have also clarified our expectations of sponsors and will reduce regulatory burden through reduced administration. The PRAC also retains those reforms introduced in the last version of the URPTG in March 2024, including flexible reporting requirements, greater transparency around the 'Early Advice' process and new user-friendly templates, which have been welcomed by stakeholders.
To complement the new PRAC, we will be releasing enhancements to our IT systems, including the TBS Portal, and the publicly accessible System for Australian Recall Actions (SARA) database, which will be renamed to the Database for Recalls, Product Alerts and Product Corrections’ (DRAC), also from early March 2025.
By simplifying our processes, updating our IT systems and ensuring our legislative powers are effective, the final phase of our reforms will improve the timeliness and efficiency of Australia’s recall processes and therefore reduce the risk of consumers and patients being harmed by unsafe products.
We will be hosting some public webinars early next year to help communicate these changes to the recall process to all stakeholders.
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