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.
