The Therapeutic Goods Administration (TGA) of Australia has announced new guidelines (PRAC, Procedure for Recalls, Product Alerts, and Product Corrections) for taking market action to address issues related to therapeutic products that may pose a risk to public health and safety.
Currently, the procedure for taking market actions to address issues with therapeutic products sold in Australia follows the URPTG (Uniform Recall Procedure for Therapeutic Goods), which must be adhered to until early March 2025. After this period, the URPTG will be replaced by the new PRAC guidelines.
The responsibility for carrying out market actions in Australia lies with the Australian sponsor. The sponsor is responsible for evaluating any situations that may impact the safety, quality, performance, or usage of medical devices, notifying the TGA, and ensuring subsequent reporting and follow-up actions.
The PRAC and URPTG both outline the procedures that sponsors must follow when carrying out market actions, but some changes introduced in the PRAC include the following:
- The categories ‘recall’ and ‘non-recall’ actions have been removed and replaced with a single category, ‘market actions’
- The 10-step recall process outlined in the URPTG has been condensed into a 5-step process in the PRAC.
- The format for presenting information in the URPTG has been simplified, with increased use of tables, diagrams, and bullet point lists.
- Starting from March 2025, the TGA will distribute the sponsor’s approved market action letters to the state and territory recall coordinators.
Australian sponsors are required to establish written agreements with manufacturers to ensure they can respond to potential market actions, and manufacturers must collaborate with sponsors to investigate and resolve issues related to medical device products. The requirements for manufacturers in this regard are as follows:
- Manufacturers must establish responsibility for analyzing potential risks related to adverse events, product defects, or complaints. [ISO 14971]
- Quality management system requirements for regulatory purposes, a system is needed, including the following:
1) Notification to the sponsor or distributor to facilitate the recall of products from all batches.
2) Investigation of the issue, including root cause identification and implementation of CAPA (Corrective and Preventive Actions)
: While sponsors can conduct their own investigations in to the issue, if the manufacturer is to investigate on behalf of the sponsor, a clear contractual agreement must be in place between the sponsor and the manufacturer.
Please refer to the link below.https://www.tga.gov.au/resources/resource/reference-material/procedure-recalls-product-alerts-and-product-corrections-prac
Procedure for recalls, product alerts and product corrections (PRAC)
A resource for sponsors conducting market actions for therapeutic goods in Australia.
www.tga.gov.au