RWE 201 – Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development

Australia has several real-world evidence (RWE) initiatives to support healthcare and drug development. The Therapeutic Goods Administration (TGA) has established a framework for the use of real-world data (RWD) and RWE in regulatory decision-making, which includes the use of data from electronic health records and disease registries [1]. Following the 2021 Review into the usage of RWE and patient-reported outcomes (PROs) in the regulation of medicines and medical devices, the TGA has been working on incorporating RWE and PROs into its regulatory processes [2][3][4].

Additionally, the Medicines Intelligence Centre of Research Excellence (MI-CRE) was established to generate timely research supporting the evidentiary needs of Australian medicines regulators and payers by accelerating the development and translation of RWE on medicines use and outcomes [4]. MI-CRE aims to equip the next generation of medicines researchers in Australia with the skills to co-create evidence with end-users [5].

Despite these initiatives, there are still challenges and gaps in Australia’s RWE landscape. A review on generating RWE on the quality use, benefits, and safety of medicines in Australia highlights the need for a roadmap to bolster Australia’s capacity to accelerate evidence development about the effectiveness, safety, and quality use of medicines in routine clinical care [6]. Robust RWE generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable healthcare and improve the health and well-being of all Australians [6].








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