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TGA Consultation on the Repurposing of Prescription Medicines

The Australian Therapeutic Goods Administration (TGA) is currently conducting a public consultation into the “repurposing” of prescription medicines. In the context of the consultation, “repurposing” is where new therapeutic uses (or ”indications”) are identified for existing medicines. Indeed, repurposing of older medicines has been an important area of research for potential COVID-19 treatments.

 Prescription medicines are sometimes used “off-label” (i.e. not for the registered indicated use) and although this may be accepted in clinical practice, such use is not approved by the TGA. A legal requirement to obtain regulatory approval for the repurposed indication may result in wider and safer use of prescription medicines, however there are challenges with relying upon preclinical data and where existing and/or repurposed indications are patent protected.

The consultation aims to understand the incentives and potential obstacles to repurposing both generic and innovator medicines that are currently, or have previously been, on the Australian Register of Therapeutic Goods (ARTG). The Consultation Paper provides three potential approaches that may be introduced to encourage the repurposing of prescription medicines, those being to:

  1. reduce the regulatory burden for repurposing medicines;
  2. further support the development of repurposed drugs through enhancing information access; and/or
  3. actively pursue registration and potential PBAC review of additional indications for medicines (including to provide a period of exclusivity for the repurposed indication and an active government-facilitated approach where a sponsor is not interested in extending the indication of an existing registered medicine).

More information can be found on the Department of Health's website. The last day to submit a response to the consultation is Tuesday, 23 March 2021.

Tags

pharmaceuticals, asiapac, regulation

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