Consultation: Proposed changes to the regulation of medicinal maggots

During the consultation period, you can send us your feedback through the TGA consultation hub. After the consultation closes, we will review all the feedback we get. We will then publish both the feedback and our decision on the same page at the TGA consultation hub.

Overview

The Therapeutic Goods Administration (TGA) is inviting industry 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. 

These reforms aim to:

• ensure the regulation of medicinal maggots is fit-for-purpose
• support 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 reclassify 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.

Submissions must be received by 10 December 2025.

Consultation document

The consultation is available at Targeted consultation: proposed changes to the regulation of medicinal maggots. For enquiries, please contact tga.scientific@health.gov.au