Australian TGA Issues Resources on Procedure for Recalls, Product Alerts, and Product Corrections

By Amelia Boldrick and Elizabeth Pugh

The Australian medical device regulator, the Therapeutic Goods Administration (TGA), announced minor updates to the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) and two new resources to assist sponsors in navigating market actions in Australia. These include a frequently asked questions (FAQ) page, as well as a guidance page on legislative powers relating to market actions that TGA can use, when necessary. 

Background: Common points of confusion in the PRAC

As we have reported, the PRAC replaced the previous guidance on the conduct of recall and non-recall actions, the Uniform Recall Procedure for Therapeutic Goods (URPTG) in March of last year. The PRAC greatly simplified the process for reporting and providing status updates on what TGA now broadly calls market actions. However, TGA acknowledges there are points on which they receive frequent questions. 

TGA has thus made minor clarifications to the PRAC itself and introduced an FAQ page with an initial set of questions/responses to which they intend to add over time. 

When guidance has legal implications

The PRAC is not a legislative instrument, and the majority of market actions are initiated voluntarily by sponsors in accordance with the PRAC. However, TGA does also have legislative powers to require sponsors to undertake, provide information about, and complete market actions in a manner consistent with the PRAC under civil penalty and/or criminal offense under Australian law. For this reason, the PRAC should not be treated as optional guidance.

The PRAC one year later

These new resources come as the first anniversary of the PRAC approaches. The questions Emergo by UL experts have encountered most frequently in our role as an Australian sponsor are not related specifically to changes introduced by the PRAC, though they align closely with those we saw under the URPTG. 

Manufacturers are still frequently surprised to learn that product problems that have no impact on safety are reportable as market actions in Australia. As with the URPTG, any deficiency that affects not only safety but also quality, performance, presentation, and/or use of the product is reportable. TGA touches on this in their FAQ directed towards sponsors of Software as a Medical Device (SaMD). Software manufacturers in particular should understand that bug fixes are typically reportable as market actions in Australia. As the number of SaMD products increases, so too does the number of market actions reported for these devices. 

Manufacturers also often still misunderstand when Australian customers can be informed of a market action. Some mistakenly believe they are permitted to contact their customers directly with a field safety notice used in other markets before the sponsor has reported the market action to TGA. As with the URPTG, TGA must review and agree to the proposed market action strategy, the manufacturer’s risk analysis (also called a health hazard evaluation), the sponsor’s draft customer letter and distribution list in advance of any action being initiated. 

The only exceptions are market actions in which there is an imminent or significant risk to patient lives or health, there is a risk of product tampering, the product is used in a clinical trial, or the product is a radiopharmaceutical, blood component, or biological. 

Concluding remarks

TGA closely monitors market actions in Australia in the interest of Australian health and safety. And provides many resources. Manufacturers and sponsors should avail themselves of these resources and follow the PRAC when made aware of a product problem. Manufacturers should confirm the Australian sponsor is referenced in their vigilance QMS procedures. 

The Australian sponsor is critical and responsible for reporting adverse events and market actions to TGA on behalf of the manufacturers they represent. Manufacturers must engage Australian sponsors who are knowledgeable about the market and experts in PMS and vigilance requirements.