Recall reforms program update

The second phase of the Recall Reforms is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining a strong emphasis on public safety. The reforms include a simplified and more flexible reporting process, increased stakeholder communication for the ‘Early Advice’ process and improvements to our recall documentation and guidance. 

In 2023, we consulted widely and developed a discussion paper on potential changes to how we undertake product recalls in Australia, as part of ongoing reforms. We 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.

Reforms to the recall process which received the broadest support from stakeholders are now being implemented. To assist in awareness and understanding of the reforms a new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) and updated guidance material have been published on our website.

Visit the TGA Consultation Hub for further information about how we are improving the recall process.