Seeking feedback on improvements to the recalls process

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on improvements to the therapeutic goods recalls process.

In Australia, recalls should be done in accordance with the procedures in our guidance document - the Uniform Recall Procedure for Therapeutic Goods (URPTG). Performing recalls in accordance with standardised and agreed procedures is important to effectively respond to issues with therapeutic goods which may pose a risk to public health and safety, and efficiently communicate information in the right way.

The URPTG has been in place for many years and while it has been effective, there have been changes to our regulatory landscape over time. There are new types of products being used, increased complexity in supply chains and changes to the ways in which we communicate.

Based on feedback and information from both internal and external stakeholders, we have reviewed the current recall process and identified some potential improvements. 

We want to know what you think about our proposed changes. We have grouped these into five themes:

1. Increasing awareness and understanding about recalls
2. Improving communication
3. Better recall descriptions
4. Improving sponsor letters and other recall documents
5. Reporting progress with a recall

We also welcome any other comments or suggestions you would like to provide.

Discussion Paper

The discussion paper gives further details about the current recalls process for therapeutic goods and the proposed improvements.

Therapeutic Goods Recall Processes - Discussion Paper

Why your views matter

If recalls are not performed in the right way, it could have a negative impact on patient's and consumer's health.

Our role is important in the oversight of therapeutic good recalls in Australia. We are investigating a range of potential improvements to the way recalls are managed. These changes could help improve health outcomes for patients and consumers, by reducing the risk posed from unsafe products.

However, before implementing any changes, we need your feedback to confirm the proposals will deliver the intended benefits, or details on how best to implement them.

We want input from all stakeholders who may be involved in the recall process. This includes industry, their customers, state and territory health departments, health professionals, healthcare organisations, wholesalers and retailers, consumers and patients and associated support groups.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).

Outcomes from the discussion paper will be provided to the Government for consideration.