Revision of the guidance document TGA Instructions for Disinfectant Testing

Closed 30 Aug 2024

Opened 22 Jul 2024

Contact

Microbiology Section, Laboratories Branch

TgaLabs.Consultation@health.gov.au

Feedback updated 3 Jun 2025

We asked

The TGA sought feedback on the drafted revision of the guidance document TGA Instructions for Disinfectant Testing. The consultation principally sought feedback on:

  • relevance of the document content
  • clarity and consistency of the document content
  • technical currency of the document content
  • structure of the document
  • additional content that would benefit the document user.

You said

7 submissions were received, primarily representing disinfectant product sponsors and manufacturers, and industry bodies.

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses supported revision of the TGA Instructions for Disinfectant Testing, and also provided many valuable comments and suggestions for improving the usability and content of the document.

We did

We have analysed all responses, and the results have informed further amendments to the guidance document. The TGA will  publish the new document version on the TGA website in the near future.

Due to the significant changes made to the document, the TGA will organise information sessions with key industry stakeholders. The TGA also recognises that the guidance document would benefit from more frequent review, and will seek to ensure that this occurs.

To maintain alignment between the guidance and regulatory requirements, minor amendments are also required to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.  The amended TGO will be registered on the Federal Register of Legislation (FRL) once signed.

Results updated 17 Jun 2025

The consultation responses and TGA's proposed actions have been summarised into a spreadsheet. Some details and comments have been removed at the request of respondents, and it may therefore appear that there are gaps in some explanations, and blank cells in the spreadsheet.

A final draft of the TGA Instructions for Disinfectant Testing (version 4.0) has been prepared, informed by the consultation responses. The TGA will progress to publication and implementation of the new document version.

Files:

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on a revised version of the guidance document ‘TGA Instructions for Disinfectant Testing’. 

The TGA Instructions for Disinfectant Testing are a regulatory tool, used to provide guidance to sponsors and applicants as to what evidence must be held for their disinfectant/sterilant products to enable inclusion of their products on the Australian Register of Therapeutic Goods (ARTG). The document is used by members of the disinfectant industry to ensure product compliance with Therapeutic Goods Order (Standard for Disinfectants and Sanitary Products) (TGO 104). Demonstration of compliance with TGO 104 is an indicator of acceptable product quality, safety and effectiveness.

This new revision of the guidance is intended to replace the existing document version (3.0), dated December 2021, which is available on the TGA website or downloadable via a link at the bottom of this page. The existing guidance is out of date and requires updating to reflect significant changes to the referenced international standards. In addition, the updated guidance aims to provide clarity and remove seemingly contradictory points.

Why your views matter

This consultation process is your opportunity to contribute to helping the TGA deliver guidance that strengthens Australia’s regulatory framework for disinfectants and sterilants that are designated as Other Therapeutic Goods, ensuring they are regulated appropriately, by providing clarity and removing sources of ambiguity. The perspectives and experiences of all stakeholders are valued and will be important in informing the updated guidance.

In this consultation, we are seeking your views on the following questions:

  • Does the revised guidance align with your understanding of the way in which Other Therapeutic Goods (OTGs) should be regulated?

  • Are there any other issues that should be addressed in the update to the guidance?

For further background and information, please refer to the draft guidance document 'DRAFT - TGA Instructions for Disinfectant Testing - 2024 review', downloadable via a link at the bottom of this page

We invite you to complete our online survey (click on the link below)

If you prefer, you can make a submission directly to the Department via post or email at the following addresses:

Microbiology Section
Laboratories Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

TgaLabs.Consultation@health.gov.au

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please make any proposed amendments using tracked changes. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.

What happens next

Feedback collated during this consultation process will inform the update to the guidance.

Audiences

  • Non-government organisations
  • Industry
  • Sponsors
  • Manufacturers
  • Other

Interests

  • Hospitals