The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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