The Therapeutic Goods Administration (TGA) regulates medicines in Australia and publishes specific pharmacovigilance guidance for sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG).
Core official resources
- Pharmacovigilance responsibilities of medicine sponsors — the central TGA guidance describing Australian pharmacovigilance requirements and recommendations.
- Report an adverse event or safety problem — current TGA reporting entry point for consumers, health professionals and sponsors.
- Database of Adverse Event Notifications (DAEN) — public access to Australian adverse-event notification data and explanatory material.
Practical use
The TGA guidance explicitly distinguishes mandatory reporting requirements from recommendations on pharmacovigilance best practice. Preserve that distinction when translating the guidance into company procedures.