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Review of real world evidence and patient reported outcomes

24 November 2021

We recently commissioned a review into our usage of real world evidence (RWE) and patient reported outcomes (PROs) in the regulation of medicines and medical devices. This considered stakeholders' understanding of what RWE and PROs are, and how we and other international regulators use them.

We use both RWE and PROs in premarket and post market evaluations, and the review found that:

  • there is ambiguity (internally and externally) surrounding our usage of RWE and PROs, which potentially limits its adoption.
  • stakeholders recommend that we improve our communication about how the TGA accept and use RWE and PROs.

Changes we're making in response to the review

From these learnings, over 2021-22 we will:

  • establish a central point for information about RWE and PROs on the TGA website.
  • clarify our related definitions and reduce ambiguity where we can.
  • request applicants to document why and where RWE and PROs have been included in the application and their purpose for inclusion.
  • begin to communicate when RWE and PROs are used in making regulatory decisions.
  • consult on relevant guidance for the use of RWE and PROs as evidence for the regulation of medicines and medical devices. These will cover generation of data (for inclusion in the dossier), and utilisation in evaluating the application. This is a developing field, and we anticipate our guidance will be an agile resource for the industry.
  • continue to learn from international sources (including medical and scientific literature, research, and regulatory guidance) for generation of RWE and PROs to maximise alignment with international regulator practices.
  • understand how we might support the enhanced use of RWE and PROs into the future. This may include providing advice to potential applicants and designers of RWE and PROs programs intended for regulatory use, and the use of RWE and PROs for medicine regulation pathways such as orphan or provisional medicines, or for repurposing of medicines.
  • encourage the adoption of medical device unique device identifiers in the broader healthcare system and specifically, in medical device registries, to support a stronger foundation for the collection of RWE and PROs.
  • consider how to best implement this work in our international collaborations.

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