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. Globally, alternative models such as personalised pharmacy-based formulations (known as magistral preparations), compassionate use provisions and flexible licensing have emerged to accommodate the biological complexity and personalised nature of phage-based therapeutics. Australia is well positioned to take a leadership role and consider a regulatory sandbox approach to the therapeutic use of phages that balances innovation with safety. Being time limited, this controlled framework would allow regulators and innovators to test new approaches under provisional rules and inform potential reforms. A sandbox should include strict participation criteria, and lead to the development of regulatory-ready biobanks of well-characterised phages, accelerating clinical access and manufacturing capacity. This model is a pragmatic and proactive approach that would enable safe scalable phage therapy in response to rising antimicrobial resistance threats.