We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
Bacteriophages, also known as phages, are viruses that specifically infect and multiply inside bacteria. They help control bacteria in natural environments. Bacteriophages are used in medicine, food safety, agriculture, and environmental science to help manage bacterial infections and contaminations.
Bacteriophage therapy is the use of one or more bacteriophages to treat a bacterial infection. The bacteriophages are selected to target and kill a specific bacterial pathogen causing the infection.
Bacteriophage therapy has been used to treat infections in patients for more than 100 years in some countries. In Australia, bacteriophage therapy products are not approved. However, they are increasingly being considered in the clinic and can be a life or limb saving therapeutic option in the treatment of multidrug-resistant infections.
In Australia, when bacteriophages are used in humans they are regulated as therapeutic goods. They are regulated under the medicine framework because they act through pharmacological and metabolic processes. This approach is consistent with how live vaccines and similar therapeutics, that also contain live viruses, are regulated.
We currently have no approved bacteriophage therapies entered in the Australian Register of Therapeutic Goods (ARTG). However, Australia legislation allows access to unapproved therapeutic goods through specific pathways, including:
Read more about accessing unapproved goods here:
Manufacturers of most bacteriophage products are still required to hold a Good Manufacturing Practice (GMP) licence and meet all standard regulatory requirements.
However, following feedback from public consultation in late 2025, we intend to amend the legislation to allow a 3-year GMP exemption for the domestic manufacture of small batch bacteriophage therapy products used to treat an infection in a particular individual or a limited number of individuals. See our guidance on Manufacturing bacteriophages products in Australia.
The exemption is expected to commence in 2026, although the exact timing is yet to be confirmed
The exemption will apply only to GMP licensing of the manufacturing site.
It will allow manufacturers to produce small batches of bacteriophage therapy products to treat a specific infection or a limited number of patients without holding a GMP licence, once the exemption is in place.
All other regulatory requirements will continue to apply. In particular:
At the end of the 3‑year exemption period, it is expected that all domestic facilities manufacturing bacteriophage therapy products will have achieved GMP compliance.
Note
Read more about supplying unapproved therapeutic goods as a sponsor.
There are several international standards that apply to bacteriophage therapies or represent current best practice. These give Australian clinicians and manufacturers practical guidance on how bacteriophage therapies can be made, tested and managed safely, based on approaches used overseas. They help users understand accepted quality and safety expectations when receiving unapproved phage therapies in Australia.
New page created.
New page created.
The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
© Commonwealth of Australia
