Recall reforms update and new procedure
20 Dec 2024
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- external site, 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’.
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.