08th September 2026 marks an important milestone in the development of maggot therapy in Australia.

The Therapeutic Goods Administration (TGA) has published a dedicated regulatory framework for medicinal maggots, formally confirming their classification as Class 2 biologicals and introducing a two-year transitional exemption from Good Manufacturing Practice (GMP) manufacturing licensing for eligible domestic manufacture.

For MedMagLabs, the announcement represents the culmination of several years of regulatory engagement aimed at establishing a clear and proportionate pathway for medicinal maggot therapy in Australia.

From regulatory uncertainty to a defined pathway

Maggot Debridement Therapy (MDT) is not a new treatment. Medicinal maggots have been used internationally for many years in the management of complex wounds.

Their regulatory position in Australia, however, has historically been much less clear.

Medicinal maggots are unusual therapeutic goods. They are living organisms, but they are neither conventional medicines nor medical devices. Their manufacture also differs substantially from many other biological therapeutic products.

MedMagLabs approached the TGA seeking clarification of how medicinal maggots should be regulated and how an Australian manufacturer could establish a compliant pathway for their production and supply.

That engagement ultimately contributed to a broader consideration by the TGA of the regulatory framework applying to medicinal maggots.

In 2025, the TGA undertook targeted public consultation on proposed regulatory changes. These included explicit classification of medicinal maggots as Class 2 biologicals and a temporary exemption from GMP manufacturing licensing to allow the emerging Australian manufacturing sector time to transition to full GMP compliance.

The TGA has now implemented that framework.

Medicinal maggots are Class 2 biologicals 

The new framework explicitly regulates medicinal maggots used in humans as Class 2 biologicals.

This provides important regulatory certainty.

It recognises medicinal maggots as living therapeutic products requiring appropriate controls over their manufacture, quality and safety, while providing a regulatory classification proportionate to their characteristics and risk.

Applicable biological standards include Therapeutic Goods Order TGO 107 for labelling requirements and TGO 109 for general and specific requirements for biologicals.

A two-year transition towards GMP licensing

The second important development is the introduction of a two-year exemption from the requirement to hold a GMP manufacturing licence for eligible domestic manufacture of medicinal maggots supplied on a patient-by-patient, case-by-case basis.

This is a transition rather than an exemption from appropriate manufacturing standards.

Manufacturers remain responsible for the quality and safety of the products they manufacture, and other applicable regulatory requirements continue to apply.

At the conclusion of the two-year period, domestic facilities manufacturing medicinal maggots will generally need to hold an appropriate GMP manufacturing licence if they are to continue supply.

For MedMagLabs, that work is already well underway. We regard the transitional period as an opportunity to complete the development, qualification and validation of a manufacturing and quality system appropriate to this unusual biological product.

What does this mean for access to maggot therapy?

The regulatory change does not mean that medicinal maggots have been approved for general supply in Australia.

There are currently no medicinal maggot products included in the Australian Register of Therapeutic Goods (ARTG).

Instead, medicinal maggots remain unapproved therapeutic goods. The TGA identifies established pathways through which registered health practitioners may access unapproved therapeutic goods for their patients, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme, as well as access associated with clinical trials.

Decisions concerning whether maggot therapy is appropriate for an individual patient and the regulatory pathway through which an unapproved therapeutic good may be accessed remain matters for appropriately qualified health practitioners.

Health practitioners seeking information about these pathways should consult the guidance published by the TGA.

Why this matters

Good regulation should protect patients without unnecessarily preventing access to useful therapies.

That balance is particularly important for therapies such as medicinal maggots, where the product and its manufacturing process do not fit neatly into regulatory systems originally designed around conventional pharmaceuticals, medical devices or more complex biological products.

The new framework provides something Australia has needed for a long time: regulatory certainty.

It establishes how medicinal maggots are classified, identifies the standards applicable to their manufacture and supply, provides a transitional pathway towards GMP licensing, and clarifies the mechanisms through which clinicians can access unapproved medicinal maggot products for their patients.

MedMagLabs’ role

MedMagLabs is proud to have initiated the regulatory engagement that helped bring this issue to the attention of the TGA and contributed to the process that has resulted in today’s framework.

Our objective has always been larger than simply establishing an Australian manufacturing operation.

We want to help create the clinical, regulatory and manufacturing infrastructure necessary for maggot therapy to become a responsibly governed and sustainable part of Australian wound care.

That means working with regulators, clinicians, researchers and the wound-care community and accepting the responsibilities that come with manufacturing a therapeutic biological product.

There remains much work to be done.

But today represents an important step.

After years of uncertainty, medicinal maggots finally have a clearly defined place within Australia’s therapeutic goods regulatory system.

For something so small, that is a very significant achievement.

Further regulatory information

Health professionals and other interested readers should refer directly to the Therapeutic Goods Administration’s guidance on medicinal maggots and the manufacture of medicinal maggots in Australia.