Seeking feedback on improvements to the recalls process

In 2023, we consulted widely on potential changes to how we undertake product recalls in Australia as part of ongoing reforms. Our discussion paper asked a series of questions around 5 key themes:

• Increasing awareness and understanding
• Improving communication
• Better recall descriptions
• Improving sponsor letters and other recall documents, and
• Reporting progress with recalls

These themes aligned with aspects of the recall process that stakeholders were advising us required the most attention. The discussion paper sought responses about the proposed changes, as well as providing the opportunity for stakeholders to have their say about any other ideas.

71 separate responses were received in total.

The Consultation responses were published in June 2023. 62 of the 71 responses consented to appearing (or partially appearing) on the TGA Consultation Hub, with 9 responses not consenting to be published.

View submitted responses where consent has been given to publish the response.

The proposals which received the broadest stakeholder support related to improvements to the recall and stakeholder communication processes and our guidance material. Respondents recommended that we:

• reduce regulatory burden by limiting unnecessary steps in the process
• ensure recall letters and notices are easy to read and have the key information up front so customers and other end users know exactly what to do
• provide greater transparency on our processes, including clarity around the timing for releasing recall information and our process for assessing the hazard classification of recall actions
• update our recall document templates
• change the focus of the Customer Acknowledgement Form to a Customer Response Form and include modern options such as QR Codes and online survey links to improve customer response rates to some sponsor recall letters, and
• give sponsors the opportunity to review the content of our Early Advice Notices prior to us seeking feedback from impacted stakeholders about aspects of the recall action before it is agreed.

To support these recommendations, we have made changes to the recall processes which will now be implemented via a new version of our guidance document, the Uniform Recall Procedure for Therapeutic Goods (URPTG) Version 2.4, which has just been published on our website. The key reforms which have been implemented addressing the above recommendations are:

Process changes

• We have reduced regulatory burden by decreasing the number of recall progress reports from 3 to 2
• We have introduced more flexible reporting requirements for sponsor submissions of the 2 reports
• The number of steps in the recall procedure has been reduced from 11 to 10.
• The ‘Early Advice Notice’ process has been expanded to include additional stakeholders such as patient support groups and health professional guilds, where appropriate. We will give sponsors the opportunity to review the content. 
• For recall actions involving ‘therapeutic goods’ which are also ‘consumer goods’, we have provided new guidance on the ‘lead regulator’ role – either the TGA or the Australian Competition and Consumer Commission (ACCC).

Changes to improve clarity and readability of the URPTG

• The recall action templates have been updated so they are easier to read and with key information up front. They have been removed from the URPTG, and instead hyperlinks included to our website directing users to the most up-to-date versions.
• The process we follow for releasing recall information has been clarified providing greater transparency.
• Clarity on the use of the ‘Early Advice Notice’ process has been included in the updated URPTG.
• Several sections have been re-written to be more concise and readable, including the process for undertaking “immediate recalls” and conducting a risk analysis.
• We have reduced the URPTG by over 20 pages by removing outdated or repeated guidance.

What's next?

Our reform work continues. One of the most endorsed proposals from our consultation paper was the new recall terminology. We will implement this when several supporting IT infrastructure changes are made to our systems. When this occurs, the new terminology and further reforms will be included in a new update to the URPTG.

We will also review:

• if further improvements can be made to our communication strategies and
• whether our existing legislative recall powers are supporting effective recall processes.

We will provide further updates as our reforms progress throughout 2024.