Learn about how we monitor the safety of therapeutic goods, or report a safety issue.
No medicine or medical device is totally risk-free. Some risks are known when the product is approved. Others are only discovered after lots of people use it.
The TGA monitors the safety of therapeutic goods in Australia and can take action to address safety concerns.
If the TGA identifies a safety concern relating to a therapeutic good, it can take regulatory action to ensure that the product continues to have acceptable safety, efficacy/performance and quality for its intended use. The TGA also seeks to ensure that health professionals and the public are aware of the safety concern and any changes to the availability and recommended use of the product.
Actions the TGA can take in response to a safety concern include:
- informing health professionals and consumers through alerts and articles in publications such as Medicines Safety Update and Medical Devices Safety Update (see the 'Publications' page for further information)
- requiring changes to product labelling, or adding warnings, precautions and adverse event information to the Product Information and Consumer Medicine Information
- cancelling the registration of the product, or limiting the population in which it can be used
- requiring the sponsor to undertake post-marketing studies to investigate the safety concern if more information is needed before a judgment can be made about the need for further action.
The links below contain information for consumers, patients and carers about the safety of medicines and medical devices.
Information for sponsors and manufacturers can be found in monitoring safety and shortages.
- Interim statement concerning the use of GS1 Australia's Recall Health platform
- Counterfeit medicines pose a health risk, but our tips can help you spot them.
- Guidance document updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002
- Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studiesThese guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity