Manufacturing of medicinal maggots in Australia
Guidance on when a manufacturing licence is required for manufacturing medicinal maggots and how a time-limited Goods Manufacturing Practice (GMP) exemption applies. Understand your regulatory obligations when producing medicinal maggot products in Australia.
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Purpose
This guidance explains how we regulate the domestic manufacture of medicinal maggots used in Australia, including when a manufacturing licence is required and when exemptions may apply under the therapeutic goods legislation.
Examples of use include:
- treating chronic, non-healing or infected wounds where conventional wound management approaches are ineffective or unsuitable, including diabetic foot ulcers, pressure injuries and post-surgical wounds, by selectively debriding necrotic tissue and reducing bacterial burden.
- treating complex wounds in humans and animals (including veterinary applications such as horses and companion animals) where surgical debridement or prolonged antibiotic therapy is not appropriate, to support wound cleansing and promote healing.
Legislation
Introduction
Medicinal maggots used in Maggot Debridement Therapy (MDT) are biological therapeutic goods and are subject to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.
Medicinal maggots are live larvae used for therapeutic purposes, including wound debridement and the management of complex or non‑healing wounds.
MDT involves breeding and preparing of live larvae under controlled conditions for therapeutic use. While their manufacture is generally less complex than some other emerging biological therapies, it may still require specific facilities, quality controls and handling processes to ensure product consistency and patient safety.
As a result, the domestic manufacture of medicinal maggots may require a manufacturing licence unless all conditions of a relevant exemption are clearly met.
Manufacturing licensing requirements
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.
If these exemptions do not apply, a manufacturing licence is required. See further information on Australian manufacturing licences and overseas GMP certification and Good manufacturing practice (GMP).
Exemptions from manufacturing licensing
Certain exemptions are set out in the Regulations and may apply to the manufacturers of medicinal maggots used in MDT, including:
- a time-limited exemption to support domestic manufacturing uplift (Item 25, Schedule 7, TG Regulations).
- manufacture for use in initial clinical trials (Item 1, Schedule 7, TG Regulations).
Time‑limited GMP exemption
To support continued access to unapproved medicinal maggot products where a manufacturing licence would otherwise be required, we have amended the legislation to provide a 2‑year GMP exemption for the domestic manufacture of medicinal maggot products supplied on a patient‑by‑patient, case‑by‑case basis.
Initial clinical trial exemption
This exemption applies only where medicinal maggots are manufactured for initial experimental use in human volunteers.
However, as MDT has a long history of use, it is unlikely that most use would be considered initial experimental use in human volunteers. Consequently, this exemption will generally not apply in this context.
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