The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Real World Evidence guidance
[PDF, 268.36 KB]
Real World Evidence guidance
[Word, 406.42 KB]
This guidance intends to outline for sponsors and manufacturers 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.