Medicine safety
General information about the safety of medicines and how it is monitored, including specific medicines guidelines.
Medicine safety guidelines
- Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines
Requirements and guidance for the reporting of adverse reactions and significant safety issues for both registered and listed medicines regulated by the TGA - Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies
These guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity
Medicine safety monitoring
- Reporting medicine and vaccine adverse events
What to report, how to report and what happens to reports - Database of Adverse Event Notifications (DAEN)
Information about adverse events related to medicines and vaccines used in Australia - Pharmacovigilance Inspection Program
An initiative to help sponsors of medicines meet their pharmacovigilance obligations
Latest alerts
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Consumers and health professionals should be aware that examples of substandard Fitaro semaglutide pre-filled syringes have been stopped at the Australian border.
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Consumers and health professionals should be aware that examples of counterfeit Roche labelled products have been stopped at the Australian border.
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The Therapeutic Goods Administration are continuing to see imports of counterfeit ivermectin.
Latest articles
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Correct administration of RSV vaccine and antibody products
Information about the indications for the individual products and how to avoid administration errors. -
Medicines containing GLP-1 and dual GIP/GLP-1 receptor agonists
New warnings added of risks during anaesthesia or deep sedation. -
Product Information safety updates - May 2025
Information for health professionals about medicines with safety related updates to their Product Information.
Latest publications
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Advisory Committee on Vaccines meeting statement 52
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Find out about the seasonal influenza vaccines available for the 2025 southern hemisphere season.
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This web publication constitutes a notice for the purposes of regulations 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations).