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Regulating the Irregular: Phage Therapy and the Case for a Regulatory Sandbox Approach in Australia

Bacteriophages (phages) are viruses that selectively kill bacteria and offer a promising option to address the growing global pandemic of antimicrobial-resistant infections. However, phage therapy does not easily align with traditional regulatory pathways designed for fixed-composition chemical drugs or biologics with fixed non-evolving compositions.

Citation:
Rizzi M, Stick SM, Hancock DG, Kicic A, Karpievitch YV. Regulating the Irregular: Phage Therapy and the Case for a Regulatory Sandbox Approach in Australia. Pharm Med. 2026.

Abstract:
Bacteriophages (phages) are viruses that selectively kill bacteria and offer a promising option to address the growing global pandemic of antimicrobial-resistant infections. However, phage therapy does not easily align with traditional regulatory pathways designed for fixed-composition chemical drugs or biologics with fixed non-evolving compositions.