Targeted consultation on proposed changes to the regulation of medicinal maggots

Feedback updated 16 Feb 2026

We asked

We invited feedback on proposed amendments to regulate medicinal maggots. The proposal included the following key elements:

  • introducing a time-limited GMP exemption for current domestic manufacturers of medicinal maggots
  • classifying medicinal maggots as Class 2 biologicals

Specifically, we sought feedback on whether:

  • a 2-year transitional GMP exemption would provide sufficient time for the sector to achieve GMP compliance
  • the proposed scope of people covered by the exemption was appropriate and adequate
  • classification as a Class 2 biological was appropriate, including whether the legislation should define the intended clinical use and scope of medicinal maggots
  • applying Therapeutic Goods Orders (TGO) 107 and 109, with appropriate adaptations, would be adequate

You said

We received submissions from registered healthcare professionals, academics, industry representatives, regulatory professionals, and members of the public. Key themes from the feedback included the following:

  • Transitional GMP exemption: The majority of respondents supported a two-year transitional exemption from GMP requirements. They emphasised that this exemption would help ensure continuity of supply and support the economic sustainability of medicinal maggots production. Respondents considered the proposed timeframe practical, as it would minimise disruption to patient care while giving the sector adequate time to achieve GMP compliance.
  • Class 2 biological classification: Respondents strongly supported explicitly classifying medicinal maggots as Class 2 biologicals. Stakeholders noted that this approach aligns with international regulatory practices and reflects the established safety profile of these products. They also highlighted that clear classification would provide regulatory certainty, simplify compliance requirements, and support access to maggot therapy for wound care across Australia. While a small number of submissions raised concerns about potential cost impacts associated with GMP requirements, respondents generally accepted these requirements as necessary to protect patient safety.
  • Intended clinical use: Stakeholders strongly supported allowing clinicians to use their professional judgement to determine the intended use of maggot therapy, rather than limiting its use solely to debridement. Respondents noted that medicinal maggots provide multiple therapeutic benefits, including reducing bioburden, exerting antimicrobial effects, and stimulating granulation tissue. Many considered restrictive definitions impractical and likely to unnecessarily limit patient care.
  • Definitions and contraindications: The majority of stakeholders supported a broad and flexible definition of medicinal maggots, without prescriptive lists of indications or contraindications. Respondents  emphasised that clinical guidelines and product labelling are more appropriate mechanisms for guiding practice. They cautioned that rigid regulatory exclusions could quickly become outdated and restrict appropriate clinical use.
  • TGO 107 and TGO 108: Respondents broadly supported applying TGO 107 and TGO 109 to medicinal maggots, provided the requirements are adapted to account for their characteristics as living organisms. Stakeholders noted that requirements for absolute sterility and donor-related provisions are not appropriate in this context. Many recommended developing tailored guidance to support safety while avoiding unnecessary regulatory burden.

We did

After considering all submissions, we intend to proceed with the proposed legislative amendments for medicinal maggots. In particular, we will:

  • amend the legislation to introduce a transitional 2-year GMP exemption for medicinal maggots
  • classify medicinal maggots as Class 2 biologicals
  • work with industry representatives to develop guidance and education resources to support a smooth and effective transition
  • publish individual submissions in line with respondent consent. 

For further questions, contact TGA.scientific@health.gov.au.

Published responses

View submitted responses where consent has been given to publish the response.

Closed 10 Dec 2025

Opened 13 Nov 2025

Contact

Scientific Operations Management Section

TGA.Scientific@health.gov.au

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

What happens next

Written submissions will help the TGA assess the proposed changes outlined in this consultation paper. Your input is essential to building a comprehensive understanding of the potential impacts of these proposed changes. We will carefully assess any regulatory burden in relation to the expected benefits.

After reviewing all feedback, the TGA will advise the Government on updates to the legislation to support the proposed amendments.

Following the consultation period, the TGA will:

  • review all submissions received
  • consider stakeholder feedback in finalising the proposed changes
  • publish a summary of responses and the final decision on the TGA website.

We appreciate your contribution and look forward to your insights.

Public submissions are published on the TGA website. For further details, refer to the section on Privacy Collection Notice in this consultation.  

Audiences

  • Biologicals
  • Commonwealth agencies
  • Health professionals
  • Industry
  • Manufacturers
  • Non-government organisations
  • Sponsors
  • State government agencies

Interests

  • Hospitals
  • Labelling and packaging
  • Legislation
  • Manufacturing
  • Regulatory policy
  • Safety