TGA consults on a proposed GMP exemption for personalised bacteriophage manufacture in Australia

Australia's Therapeutic Goods Administration consulted on a proposed time-limited GMP exemption for manufacturers of personalised bacteriophage therapy products, which are currently supplied as unapproved goods under the Special Access Scheme and Clinical Trial Notification scheme; there are no GMP-licensed bacteriophage facilities in Australia. Feedback will inform amendments to the Regulations. The consultation ran from 16 October to 13 November 2025, with submissions due by 11:59pm on 13 November 2025.