We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Real World Evidence guidance
[PDF, 268.36 KB]
Real World Evidence guidance
[DOCX, 406.42 KB]
This information is for sponsors and manufacturers outlining the types of RWE relevant in the Australian context.
It also aims to show our process for assessing RWE, including limitations of RWE compared to traditional clinical trials for safety and performance.