Update on the TGA Recall Reforms Program and release of updated guidance – URPTG Version 2.4

This Tech alert provides an update for members on the progress of the TGA’s Recall Reforms Program. In 2023, the TGA consulted publicly on potential changes to how product recalls are undertaken in Australia. The TGA 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 advised the TGA 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. 

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

  • 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 TGA processes, including clarity around the timing for releasing recall information and processes for assessing the hazard classification of recall actions; 
  • update to the 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 the Early Advice Notices prior to the TGA seeking feedback from impacted stakeholders about aspects of the recall action before it is agreed. 

  

To support these recommendations, the TGA have made changes to the recall process which will now be implemented via a new version of the TGA guidance document, the Uniform Recall Procedure for Therapeutic Goods (URPTG) Version 2.4, which has just been published on the TGA website. If you have any saved webpage bookmarks, you may need to refresh your browser (F5 in Windows or Command+R on a Mac) to see the updated webpage. 

The key reforms which have been implemented addressing the above recommendations are: 

Process changes 

  • The TGA have reduced regulatory burden by decreasing the number of recall progress reports from 3 to 2; 
  • more  flexible reporting requirements for sponsor submissions of these reports has been introduced; 
  • 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. The TGA will give sponsors the opportunity to review the content.  
  • For recall actions involving ‘therapeutic goods’ which are also ‘consumer goods’, the TGA has 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, with key information up front. They have been removed from the URPTG, and instead hyperlinks included to the TGA website, directing users to the most up-to-date versions; 
  • the process the TGA follows 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; and  
  • The URPTG has been reduced by over 20 pages by removing outdated or repeated guidance. 

  

What’s next? 

The TGA has advised that their reform work continues and stakeholders will be provided additional updates as the reforms progress throughout 2024, noting that one of the most endorsed proposals from the consultation paper was the new recall terminology. The TGA has provided that they will implement this when several supporting IT infrastructure changes are made to their systems. When this occurs, the new terminology and further reforms will be included in a new update to the URPTG. 

The TGA will also review: 

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

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