24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported outcomes in the regulation of medicines and medical devices. 

This considered stakeholders' understanding of what real world evidence and patient reported outcomes are, and how the TGA and other international regulators use them.

The TGA uses both real world evidence and patient reported outcomes in premarket and post market evaluations, and the review found that:

• There is ambiguity (internally and externally) surrounding our usage of real world evidence and patient reported outcomes, which potentially limits its adoption.
• Stakeholders recommend that the TGA improve its communication about how the TGA accept and use real world evidence and patient reported outcomes

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