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Early Warning System

This is a joint project to establish a Trans-Tasman early warning system to advise healthcare professionals and the public of potential safety signals for medicines and medical devices.

In April, the TGA and Medsafe jointly hosted a number of workshops with key stakeholders to obtain information about the design of this system and how safety information should be communicated.  The purpose of the workshops was not to decide on a particular methodology for an early warning system.

Workshop participants were provided with a briefing document detailing the aims, possible scenarios and a list of questions designed to stimulate discussion:
Briefing document (pdf 119KB).

The feedback from the workshops will inform the design of the system:
Summary of feedback (pdf 258KB).

Medsafe and the TGA are now in the process of designing an early warning system.  This page will be updated when further information is available.