Australian TGA Updates Recall Reforms Program, Releases Version 2.4 of the URPTG

By Amelia Boldrick and Elizabeth Pugh

The regulator in Australia, the Therapeutic Goods Administration (TGA) communicated an update (March 26, 2024) on its Recall Reforms Program. This coincides with the release of an update to the seminal recall guidance for sponsors, the Uniform Recall Procedure for Therapeutic Goods (URPTG).

Background on TGA Recall Reforms Program

In 2021 and 2022, the TGA held workshops and stakeholder meetings to identify areas for improvement in the recall of drugs, biologicals and medical devices in Australia (“therapeutic goods”). This culminated in the January 2023 publication of a discussion paper announcing a phased approach to update the recall system, also seeking feedback on areas of planned reform.

Changes in the URPTG Version 2.4

The announcement highlighted several process changes outlined in version 2.4 of the URPTG:

• Removal of the requirement for a 2-week status update report
• Addition of patient support groups and health professional guilds to the stakeholders included in the Early Advice Notice process
• Additional clarification on the ‘lead regulator’ in consumer-level recall actions, which involves both the TGA and the Australian Competition and Consumer Commission (ACCC)

Additional changes to the URPTG

The URPTG has been edited for conciseness and readability. The number of pages has been reduced by nearly one-third. The recall action templates have been improved and are now posted to the TGA website independent of the URPTG.

There is additional clarity around the definition of Class III recall actions, including a guide for estimating the classification. Similar to the U.S. FDA, the TGA views Class I recalls as the most serious and Class III recalls are viewed as less serious.

There is more information about TGA processes such as the release of recall information and Early Advice Notice communications sent to Australia’s state and territory recall coordinators, as well as the undertaking of “immediate recalls.”

Concluding remarks

Further reforms are expected to follow and will be published in a future version of the URPTG after IT infrastructure changes are finalized. This includes changes to the terminology and categories used to describe various recall and non-recall actions, all of which must be reported to TGA in advance of initiation, regardless of whether or not a corrective action is taken to address a safety issue.

Emergo has served as an Australian sponsor for more than a decade. Our expertise in Australia includes representation and ARTG listing support, as well as consulting on adverse events and corrective actions, reimbursement for implantable devices and applications for TGA Conformity Assessment Certification