Bacteriophages

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:

• the Special Access Scheme (SAS), which allows Australian registered health practitioners to access an unapproved therapeutic good for an individual patient on a case-by-case basis.
• the Authorised Prescriber Scheme (AP), which allows authorised medical practitioners to access and supply a specified unapproved therapeutic good (or class of ‘unapproved’ therapeutic goods) to a class of patients with a particular medical condition.
• Clinical trials. If you plan to run a clinical trial in Australia using an unapproved therapeutic good, you must either:
  • notify us - via the Clinical Trial Notification (CTN) scheme
  • apply to us - via the Clinical Trial Application (CTA) scheme.
• Unapproved therapeutic goods have not been assessed by us for quality, safety or efficacy.

Read more about accessing unapproved goods here:

• Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods
• Becoming an authorised prescriber for unapproved therapeutic goods in Australia
• How we regulate Australian clinical trials that use unapproved therapeutic goods

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

What the GMP exemption covers

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.

What the GMP exemption does not cover

All other regulatory requirements will continue to apply. In particular:

• supply must continue to occur under unapproved goods pathways, such as the Special Access Scheme (SAS) or Clinical Trial Notification (CTN) scheme
• adverse event reporting to us remains mandatory
• advertising restrictions for unapproved therapeutic goods still apply.

What happens after the exemption ends

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.

• European Pharmacopoeia Eleventh Edition Supplement 11.6 Phage therapy medicinal products European Pharmacopoeia - General chapter 5.31 - Phage therapy medicinal products
• Belgian General Monograph v1.0 – Phage active pharmaceutical ingredients. EMA/CHMP/BWP/1/2024 2 Committee for Medicinal Products for Human Use (CHMP) Published 6 October 2025 Guideline on quality aspects of phage therapy medicinal products- external site (draft)
• Regulatory considerations for therapeutic use of bacteriophages in the UK - GOV.UK- external site Published 4 June 2025