The Therapeutic Goods Association (TGA) is conducting a public consultation concerning the repurposing of medicines listed, or previously listed, in the Australian Register of Therapeutic Goods (ARTG).
Unfortunately, encouraging research, development, and eventual registration of new indications for existing medicines has proved challenging.
The TGA stress, current regulatory, administrative, and commercial hurdles hinder sponsors from seeking extensions of indications for novel uses. This is particularly true where medicines are ‘off-patent’.
Specifically, the TGA state:
“An extension of indication…involves a high administrative burden and significant costs for the sponsor”.
To alleviate these barriers, the TGA aims to:
“improve the environment to encourage the repurposing of medicines, with a primary focus on novel clinical uses”.
According to a TGA media release, the regulatory body hopes to:
“Address commercial and intellectual property issues”;
“Identify the best candidates for repurposing”;
“Shortlist candidates”; and
“Approach and incentivise the market”.
The consultation period commenced 10 March 2022 and will conclude 1 April 2022. The relevant consultation and its scope are located here. Further, a supplementary media release explaining the consultation can be found here.
We can help your organisation overcome any regulatory matters involved in repurposing medicines.
Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.
Contact us directly at info@komplyaus.com for more information.
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