What are medicinal maggots
Medicinal maggots are live larvae, typically of the species Lucilia sericata, that are bred under controlled conditions for medical use. They selectively remove necrotic tissue, reduce bacterial burden and promote wound healing through mechanical and biochemical action.
Medicinal maggots are used to support the management of chronic, non-healing and infected wounds.
Therapeutic use of medicinal maggots
Maggot Debridement Therapy (MDT) involves the application of live medicinal maggots to a wound to remove dead or damaged tissue, reduce infection, and promote healing.
MDT has been used in patients for many years in a range of countries. It is used as a treatment option where conventional wound management approaches are ineffective or unsuitable. MDT can be an important therapeutic option for patients with complex or non‑healing wounds where alternative treatments have failed or are not appropriate.
In Australia, medicinal maggots are not currently included in the Australian Register of Therapeutic Goods (ARTG), but they can still be accessed through approved pathways for unapproved therapeutic goods.
Regulation of medicinal maggot products in Australia
In Australia, these goods are regulated under the biologicals framework because they are living organisms used for a therapeutic purpose. Medicinal maggots are regulated as Class 2 biologicals.
Their regulation under the biologicals framework reflects the unique characteristics of living therapeutic products and supports appropriate oversight of their manufacture, supply and use. This approach is consistent with how other products derived from, or containing, living human or animal material are regulated.
Access to medicinal maggots
There are currently no approved medicinal maggot products included in the ARTG. However, the legislation allows access to unapproved therapeutic goods through specific pathways, including:
- the Special Access Scheme (SAS), which allows Australian registered health practitioners to access an unapproved therapeutic good for an individual patient on a case‑by‑case basis
- the Authorised Prescriber (AP) Scheme, which allows authorised health practitioners to prescribe and supply a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to a class of patients under their care
- clinical trials.
Unapproved therapeutic goods have not been assessed by the TGA for quality, safety or performance.
Read more about accessing unapproved goods here:
- Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods
- Becoming an authorised prescriber for unapproved therapeutic goods in Australia
- How we regulate Australian clinical trials that use unapproved therapeutic goods
- Supplying unapproved therapeutic goods as a sponsor
Good Manufacturing Practice (GMP) and current exemption
Manufacturers of medicinal maggots are generally required to hold a Good Manufacturing Practice (GMP) licence and meet all standard regulatory requirements.
However, following feedback from public consultation in late 2025, a 2-year GMP exemption for domestic manufacturers of medicinal maggots is now in effect.
This exemption reflects the current maturity of this manufacturing sector. At the end of the 2-year exemption period, domestic facilities manufacturing medicinal maggot products will be expected to either hold an appropriate GMP licence or cease supply.
For more information, see our guidance on Manufacturing medicinal maggots in Australia.
What the GMP exemption does not cover
All other regulatory requirements will continue to apply. In particular:
- supply must continue to occur under unapproved goods pathways, such as the Special Access Scheme (SAS) or Clinical Trial Notification (CTN) scheme
- adverse event reporting requirements continue to apply
- advertising restrictions for unapproved therapeutic goods still apply
Manufacturers and sponsors remain responsible for ensuring medicinal maggots supplied for human use meet appropriate standards of quality and safety.
Standards and guidance
Several quality standards apply to medicinal maggot products and outline requirements for their manufacture, testing and supply.
These standards establish minimum quality and safety requirements for medicinal maggot products supplied in Australia and help users understand the expectations that apply when receiving MDT.
The applicable standards are outlined in the following Therapeutic Goods Orders:
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