Data standards for drug and biological product submissions containing real-world data – Draft guidance for industry

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Overseas effective date: Draft guidance - October 2021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.