The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.
The pages linked below contain information for sponsors and manufacturers.
Recalls & alerts
- Recalls
A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation
- Alerts
Safety alerts and advisory statements about medicines and medical devices in Australia
- Uniform recall procedure for therapeutic goods (URPTG)
The uniform recall procedure for therapeutic goods provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia
- Product contamination & extortion - a protocol for the therapeutic goods industry
Developed by the Industry Government Crisis Management Committee as a joint industry-government initiative, with the aim of assisting managers in responding to a product contamination and/or extortion event directed at the therapeutic goods industry
Reporting problems
Product Information/Consumer Medicine Information
- Improved Consumer Medicine Information template
9 September 2019 The TGA, in consultation with consumer, health professional and pharmaceutical industry representatives, has developed an improved template for CMI
- Product Information (PI)
A new Product Information (PI) form was approved on 8 November 2017, with a commencement date of 1 January 2018. The new format is being introduced with a 3 year transition period, ending 31 December 2020.
Safety monitoring
Transmissible spongiform encephalopathies (TSEs)