Early warning system
The Early Warning System includes current and historical information on safety concerns for medicines and medical devices (also known as therapeutic products) that the TGA has identified through its therapeutic product vigilance program.
There are two types of communications that can be issued as part of the Early Warning System:
- Monitoring communications
These early communications are intended to highlight potential safety concerns that are identified by the TGA. In addition, the TGA aims to encourage further reporting and research to provide more information on these safety concerns. These concerns have not been fully investigated.
- Alert communications
These communications are issued once a safety concern has been investigated. Alerts contain more information on the safety concern and provide advice on actions that may need to be taken by health professionals and consumers.