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
- Hazard alert: Hintermann Series H3 Total Ankle Replacement SystemBe alert about a higher risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system. Read this if you're a patient, carer or health care provider.
- Product defect correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - potential for control line variabilityThe companies supplying Fanttest COVID-19 test kits were made aware of the potential for variability in the way the control line appears (ie a weak/faint/pale control line) when strong COVID-19 positive results are obtained.
- Substandard semaglutide vialsThe product tested is not listed in the ARTG and has not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation.
Latest articles
Recall reforms program updateThe second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.- Philips’ recall action for sleep apnoea and respiratory care machines – Final chance to register for a replacement deviceIf you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks.
- COVID-19 vaccine safety report - 02-11-23In line with the official end of the COVID-19 emergency response, this will be our last regular COVID-19 Vaccine Safety Report. We will continue safety monitoring of COVID-19 vaccines.
Latest publications
- Medical Devices Safety UpdateMDSU provides practical advice and information about medical device safety.
- 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.