Safety
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.
Resources
Latest alerts
- Product Defect Correction: Permobil Push-tracker/Smart DriveFind out about a software problem with the SmartDrive MX2+ App, for the PushTracker E2 and E3 wearable watches, causing safety issues for operating manual wheelchairs.
- Medicines containing turmeric or curcumin - risk of liver injuryThe TGA has received reports of liver problems experienced by consumers taking medicines containing turmeric or curcumin.
- EVE Allylisopropylacetylurea tabletsThe TGA is warning consumers against taking EVE branded products that contain allylisopropylacetylurea (apronal) as they pose a significant health risk and are prohibited from sale, supply or use in Australia.
Latest articles
- COVID-19 vaccine safety report - 21-09-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- COVID-19 vaccine safety report - 07-09-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- Post-market review of facemasks closedThe COVID-19 pandemic post-market review of facemasks is now finished.
Latest publications
- 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
- Manufacturing Quality Branch annual reportsThe TGA has published insights into recalls and GMP regulation for 2019-20.
- Recalls annual report 2019-20Insights into therapeutic goods safety regulatory activity for our recalls program.