The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
No therapeutic product is ever completely risk free. Some risks may be known when a medicine or medical device is first entered on the Australian Register of Therapeutic Goods (ARTG). However, some information only comes to light after more people use the products.
This section includes current and historic recalls of medicines and medical devices, advice that the TGA has issued about products, monitoring communications, information on reporting problems and how the safety of therapeutic products are monitored.
Reporting problems
- Report a problem or side effect
What you should report and how you can report
Alerts
Alerts provide important information and recommendations about therapeutic products. When an alert is issued, it does not necessarily mean a product is considered unsafe.
- Current year alerts
View alerts issued by the TGA during the current year - All alerts
View all alerts issued by the TGA since 1998
Product recalls
- Recalls
Actions taken to resolve a problem with a therapeutic good already supplied in the market - Safe disposal of unwanted medicines
Unwanted medicines can be returned to local pharmacies involved in the Return Unwanted Medicines (RUM) project
Prescription opioids
- Prescription opioids
Upcoming changes to reduce harm
Medicine shortages
- Medicine shortages information
Find out about current Australian medicine shortages and what to do if a medicine is in shortage - Medicine shortage reports database
Search for current and anticipated national medicine shortages - Accessing medicines during a medicines shortage
The TGA can approve the import and supply of a medicine that is not included in the ARTG under section 19A of the Act
Early warning system
The early warning system includes current and historical information on safety concerns for medicines and medical devices that the TGA has identified through its therapeutic product vigilance program.
Black Triangle Scheme
The Black Triangle Scheme provides a simple means for health professionals and patients to identify certain types of new prescription medicines, or those being used in new ways. It also aims to encourage patients and health professionals to report adverse events resulting from their use.
Safety information and education
- Medicines safety
General information about the safety of medicines and how safety is monitored - Medical devices safety
General information about the safety of medical devices and how safety is monitored - Database of Adverse Event Notifications (DAEN)
Searchable database of adverse event reports received by the TGA