New Australian Procedure for Recalls, Product Alerts and Product Corrections

By Amelia Boldrick and Elizabeth Pugh

This month the regulator in Australia, the Therapeutic Goods Administration (TGA), announced a preview of a new guidance resource for therapeutic goods corrective actions. The new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) aims to simplify and modernize the existing process to report and execute corrective actions for drugs, biologicals and medical devices. The PRAC will take effect in March 2025, though TGA recommends that stakeholders become familiar with it now.

Background on vigilance

As we at Emergo by UL reported in March, the TGA has recently improved its current recall procedures. Initially implemented in 2018, the Uniform Recall Procedure for Therapeutic Goods (URPTG) has long served as the regulatory handbook for Australian manufacturers and sponsors (hereafter collectively referred to as “sponsor”) managing recall and non-recall actions. The Australian medical device regulatory system shares some characteristics with the European system, including its risk-based classification rules. However, vigilance reporting significantly diverges.

The URPTG was complex

All corrective actions in Australia are reportable to TGA regardless of whether the catalyst for correction poses any health risk or whether the type of action is a recall or non-recall. Each type of action includes several subtypes, depending on the nature of the problem and proposed remediation. The sponsor must then specify the depth of the recall, whether wholesale, hospital, retail, or consumer-level. Finally, recall actions are assigned a hazard classification from I to III, with Class I representing the highest level of risk and Class III the lowest.

Importantly, the sponsor must obtain written approval from TGA on the proposed recall strategy and customer letter before communicating with customers or initiating any action for all but the most serious recalls involving blood, biologicals, radiopharmaceuticals, or recalls for issues posing an imminent threat to patients or public health.

PRAC: Reducing complexity and regulatory burden

Although it maintains some of the enhancements implemented earlier this year, the PRAC will replace the URPTG in March 2025. It eliminates the terms used in the URPTG “recall” and “non-recall” in favor of the unifying term “market action”. The eight total subtypes between recall and non-recall actions have similarly been reduced to just four under market action.

The PRAC additionally distills the ten current recall steps in the URPTG to five and streamlines the format in which information in the URPTG is presented with greater use of tables, figures, and bulleted lists than its predecessor.

With the PRAC, TGA will relinquish some of the review of distribution information

In March of 2025 TGA will also begin proactively distributing customer distribution lists to state and territory recall coordinators upon approval of a proposed market action. Instead of verifying distribution information with the sponsor in advance of approval as is currently done, TGA will instruct the local recall coordinators to contact the sponsor with any questions or concerns regarding the accuracy of the information provided.

Concluding remarks

The PRAC brings clarity and simplicity to one of the most complex regulatory activities that manufacturers and sponsors in Australia face post-market. We at Emergo have managed hundreds of corrective actions in Australia on behalf of manufacturers and applaud TGA’s efforts to clarify its processes and reduce regulatory burden. We look forward to implementing the PRAC next year in our role as Australian sponsor.