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
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Consumers and health professionals should be aware that counterfeit Ozempic-labelled pens have been imported into Australia. These pens may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for.
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We have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
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Read our safety advisory about this ingredient's potential to cause severe allergic reactions including anaphylaxis.
Latest articles
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Medical devices affected by 3G network closure
Some medical device equipment could soon be affected as mobile network operators prepare to switch off their 3G networks. -
Product Information safety updates - July 2024
Information for health professionals about medicines with safety related updates to their product information. -
Making therapeutic goods safer for everyone
One of the key functions of the Therapeutic Goods Administration (TGA) is to closely monitor the safety of therapeutic goods. But to properly monitor safety, we need everyone to report any side effects and problems they have.
Latest publications
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MDSU provides practical advice and information about medical device safety.
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These guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity
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The TGA has published insights into recalls and GMP regulation for 2019-20.
Latest guidance
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This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.
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Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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Guidance on how medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.