Safety monitoring and information

Safety is determined by weighing the known and potential risks, against the expected benefits when a therapeutic good is used as intended. While some risks are identified during the approval process, others may only become apparent after broader use.

The safety of therapeutic goods is a shared responsibility between regulators, sponsors, healthcare professionals and consumers.

We monitor safety through a range of different activities: 

• Pre-market evaluation: Products must meet strict safety, quality and efficacy standards before being included in the Australian Register of Therapeutic Goods (ARTG).
• Post-market surveillance: We monitor products once they are on the market through adverse event reports, product testing, recalls and safety reviews.
• Adverse event reporting: Anyone can report adverse events or side effects, product defects or safety concerns. These reports help identify emerging risks and inform regulatory action.
• Product testing and investigations: Our laboratories test therapeutic goods to ensure they meet Australian standards and compare results with international benchmarks. See further information on our Product testing and investigations.
• Recalls and market actions: If a safety issue is identified, we may initiate recalls, issue safety alerts or require product corrections.

A key activity in safety monitoring is identifying patterns that emerge when problems are reported by sponsors, health professionals and consumers. An adverse event occurring does not necessarily mean that there is something wrong with a therapeutic good. However, each report helps to build a picture of the safety profile of a product. You can Report an adverse event or safety problem.