Targeted consultation on proposed changes to the regulation of medicinal maggots

Overview

The Therapeutic Goods Administration (TGA) requests your feedback on proposed regulatory changes to ensure the legislation governing medicinal maggots is fit-for-purpose. Specifically, this consultation seeks feedback on the following proposals:

(1) a 2-year transitional licensing exemption from the operation of Part 3-3 of the Therapeutic Goods Act 1989 (the Act) in relation to the manufacture of medicinal maggots (referred to in this paper as the Good Manufacturing Practice (GMP) exemption); and

(2) reclassification of medicinal maggots from Class 4 (high risk) to Class 2 (lower risk) biologicals.

The TGA wants to ensure the regulation of medicinal maggots is fit-for-purpose, supports manufacturers to maintain the uninterrupted supply of medicinal maggots, considers patients’ need to access, while ensuring quality and safety of treatments. Your input is essential to help ensure the proposed changes are practical, effective, and aligned with industry needs.

Why your views matter

No medicinal maggot product is registered on the Australian Register of Therapeutic Goods (ARTG) to support current supply, and viable animal cells and tissues are currently specified to be Class 4 (highest risk) biologicals.  Classifying medicinal maggots as Class 4 biologicals is not considered appropriate. When the biological framework was amended to classify viable animal cells and tissues as Class 4 biologicals it did not anticipate the risk profile of whole organisms such as medicinal maggots. The consideration at the time was xenotransplantation products, which are often genetically modified viable animal cells or tissues with a high viral safety transmission risk, that are transplanted into patients.  The risk profile associated with the use of medicinal maggots is considered much lower than xenotransplantation products.

Now having considered whole organisms, such as maggots, we are proposing the transition of medicinal maggots to Class 2 biologicals (lower risk) to better match their risk profile and mechanism of therapeutic use.

In addition, it is proposed to introduce a temporary exemption from GMP requirements (Part 3-3 of the Act) for manufacturers of medicinal maggots. This is intended to balance the need for ongoing supply of a lower risk product with providing a clear expectation of manufacturers looking to supply approved medicinal maggots in the future.

These reforms aim to ensure that:

• medicinal maggots are appropriately classified and regulated in Australia
• manufacturers are supported to maintain essential ongoing supply
• clear regulatory expectations are provided to manufacturers planning to supply approved medicinal maggots in the future
• patients continue to have access to safe and high-quality treatments.

Submission details

Submissions to this targeted consultation are by invitation only. Please refer to your invitation email for instructions on how to provide feedback.

The closing date for submissions is on 10 December 2025. All feedback received by this deadline will be considered by the TGA.

For more information or to discuss the proposal, please email TGA.Scientific@health.gov.au.

Consultation Paper

Consultation on proposed changes to the regulation of medicinal maggots