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
- Adverse events: Australian statistics on medicines
Reports for incorporation into the Department of Health publication Australian Statistics on Medicines - Therapeutic product vigilance
TGA's approach to therapeutic product vigilance - 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
Latest alerts
-
Extra safety information is being added to all montelukast products to highlight the existing warnings about serious behaviour and mood-related changes.
-
Gold Max Blue capsules pose a serious risk to your health and should not be taken.
-
Dynamint X tablets pose a serious risk to your health and should not be taken.
Latest articles
-
Don’t risk using tanning products containing melanotan
Australians who use tanning products containing ‘melanotan’ are at risk of serious health problems. -
Product Information safety updates - January 2025
Information for health professionals about medicines with safety related updates to their Product Information. -
More prominent safety warnings about the neuropsychiatric effects of montelukast
Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.
Latest publications
-
This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
-
Advisory Committee on Medicines meeting statement
-
Advisory Committee on Medicines meeting statement