The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
About this guideline
Adopted by the TGA: 27 February 2023
Overseas effective date: Draft guidance - October 2021
Categories: FDA ꘡ Real World Data/Real World Evidence (RWD/RWE)
TGA annotations:
The general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.
The TGA will monitor the US FDA status of this draft and will consider if further consultation or annotation is required once it moves to a fully adopted guideline. Further consultation will only occur if the principles are materially altered.
Where FDA guidelines adopted in Australia include references to US legislation, the requirements contained in the referenced US legislation are not applicable to the evaluation of medicines by the TGA.
For more information see International scientific guidelines adopted in Australia.