TGA’s public consultation on the repurposing of prescription medicines

The Australian Therapeutic Goods Administration (TGA) is holding a public consultation on the repurposing of prescription medicines.

Drug repurposing is a concept that appeals to many stakeholders in the world of drug development. The process of identifying a new use for an existing medicine has several potential benefits. With repurposed medicines already having completed preclinical development, there is less time and money invested in the early stages of drug development. Accelerated access to a lower risk medicine through repurposing will in turn have public health benefits, something that has been highlighted during the COVID-19 pandemic.

The aim of the TGA’s consultation is to understand the potential obstacles and/or incentives that may influence a sponsor’s decision to repurpose an existing medicine in particular:

  • For indications already approved overseas
  • For a less common disease
  • Where there is an already accepted off-label clinical use
  • Where it is likely to be less profitable.

Responses to the consultation may be used to shape regulatory reforms and future policies.

The public consultation ends on 23 March 2021.

For full details on the consultation and how to take part, click here.