Manufacturing bacteriophages products in Australia

Bacteriophage products are biological therapeutic goods and are subject to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

Under the Therapeutic Goods Act 1989 (the Act), a manufacturing licence is required for all sites in Australia that manufacture therapeutic goods, unless a specific exemption applies.

This requirement applies to:

• commercial manufacturers
• public and private healthcare facilities
• individuals who manufacture therapeutic goods for human use.

A manufacturing licence is required whether the goods are supplied commercially or not, unless an exemption in the Therapeutic Goods Regulations 1990 (the Regulations) applies.

Certain exemptions from manufacturing licensing are set out in the Regulations. Some of these exemptions may be relevant to current domestic manufacturers or individuals involved in the manufacture of bacteriophage products.

Legislation
Relevant exemptions are primarily located in Schedule 7 and Schedule 8 to the Regulations.

Experimental use and manufacture by medical practitioners

An exemption from manufacturing licensing may apply where all steps of manufacture of a bacteriophage product are:

• for initial experimental use in human volunteers, under Item 1 of Schedule 7 to the Regulations or
• carried out by a medical practitioner who manufactures the therapeutic good specifically for a patient under their care, under Item 1 of Schedule 8 to the Regulations.

When the exemption under Schedule 8 applies

The exemption under Item 1 of Schedule 8 applies only if all of the following conditions are met:

• the medical practitioner personally manufactures the therapeutic good (the exemption is unlikely to apply if other staff carry out the manufacture under the practitioner’s supervision) and
• the therapeutic good is made specifically for a patient who is under that practitioner’s care.

If these conditions are not met, a manufacturing licence is required. See further information on Australian manufacturing licences and overseas GMP certification and Good manufacturing practice (GMP).

An exemption from manufacturing licensing may apply, under Item 3 of Schedule 8 to the Regulations, where all steps of the therapeutic goods are manufactured by a:

• biomedical engineer
• radiochemist
• pharmacist.

This exemption applies only if the manufacture:

• takes place in a public hospital or public institution, and
• is carried out by a person employed by that hospital or institution.

The therapeutic goods must also be manufactured:

• for supply in hospitals or public institutions, and
• within the same State or Territory.

If these conditions are not met, a manufacturing licence is required. See further information on Australian manufacturing licences and overseas GMP certification and Good manufacturing practice (GMP).

Bacteriophage products are usually complex to make and can take significant time and requires specialist expertise.

Because of this:

• manufacture is unlikely to be done by a single medical practitioner; and
• manufacturing activities are unlikely to fully meet the conditions of the existing exemptions in Schedules 7 or 8 of the Regulations.

As a result, most domestic manufacture of bacteriophage products currently require a manufacturing licence, unless all conditions of the specific exemption detailed above are clearly met. To ensure regulation of unapproved BTPs remains fit-for-purpose and considers patients’ need to access as well as the quality and safety of treatments administered, we conducted a public consultation in 2025.

Following feedback from the public consultation in late 2025, we intend to amend the legislation to allow a 3year GMP exemption for the domestic manufacture of small batch bacteriophage therapy products used to treat an infection in a specific person or a small number of people.

The exemption is expected to commence in 2026, although the exact timing is yet to be confirmed.

Read more about the Good Manufacturing Practice time-limited exemption.