Consultation: Proposed GMP exemption for certain bacteriophage manufacture

Submissions should be provided through our consultation hub. Submissions must be received by 11:59pm on 13 November 2025. After that the submissions and our decision will be available on the same page at the TGA consultation hub - external site.

Overview

The Therapeutic Goods Administration (TGA) is seeking your feedback on a proposed time-limited GMP exemption for manufactures of personalised bacteriophage therapy products (BTPs). 

In the last 5-10 years, increasing anti-microbial resistance (AMR) and medical device-related infections have led to the resurgence in interest from researchers and clinicians seeking access to experimental therapies for their patients. Unapproved BTPs are increasingly being considered. However, BTPs have not had their efficacy, safety or quality assessed by the TGA and are currently being supplied as unapproved goods under the Special Access Scheme (SAS) and Clinical Trial Notification (CTN) scheme provisions.

The manufacturing process of BTPs is multifaceted and complex and there are no Good Manufacturing Practice (GMP) licensed bacteriophage facilities in Australia. The TGA supports the development of innovative therapies, and this proposal aims to support the bacteriophage sector whilst it upgrades manufacturing facilities, develop standards and collect clinical data to support the safe use of these products for patients. Inhibiting the domestic manufacture may force medical providers to import BTPs from overseas which may significantly increase the timeframe for patients to receive treatment and would not necessarily ensure a higher quality product. 

The TGA wants 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. Feedback obtained from this consultation will inform amendments to the Regulations. 

Submissions must be received by 11:59pm on 13 November 2025 and should be provided through the consultation hub.

Consultation document

Consultation on including a time-limited GMP exemption for manufacturing of personalised bacteriophages.

We aim to provide documents in an accessible format. If you're having problems using this document, please contact TGA.Scientific@health.gov.au.