Therapeutic Goods Legislation Amendment effective from 1 October 2025

Background

The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation.

The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing we conduct assesses compliance with quality and performance standards for the therapeutic goods. This testing provides us, as the regulator, with scientific data to inform and support regulatory decisions and actions, ensuring the safety of therapeutic goods for Australian consumers.

Part 5 of the Regulations (Part 5) sets out procedures for testing of goods to be conducted under the Regulations. An internal review of Part 5 identified reform opportunities to ensure that the part is well designed for its purpose, can accommodate the latest and future innovations and testing methodology, is efficient to administer, and is transparent and flexible.

Public consultation

In alignment with our commitment to continuous improvement and consulting with stakeholders on changes to policy and legislation, a public consultation on proposed changes to Part 5 of the Regulations went live on 24 June 2024 and closed on 28 August 2024. Proposed changes were broadly supported by respondents. For an overview of the consultation see the public consultation Reforming Australia’s Therapeutic Goods Testing Regulations.

Summary of amendments

On 1 October 2025, the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025 will amend the Regulations to repeal and replace Part 5. The purpose of these amendments, broadly, is to improve the clarity and functionality of Part 5.

The new Part 5 authorises the Secretary to nominate APS employees as analysts who may select and test samples of goods under the part for the purpose of the administration of the Act or legislation made under the Act. The new part provides for testing to be conducted by an analyst, or by another appropriate person or body.

At the completion of testing under Part 5, an analyst must issue a certificate which documents the testing conducted and the results of the testing. The certificate may also contain other information relating to the sample tested or the testing conducted.

Transitional arrangements

Transitional arrangements ensure continuity of testing of goods, as certain goods obtained by the department prior to commencement of the amendments may still need to be tested under Part 5 as in force prior to these amendments.

Enquiries

For enquiries relating to the transition period or any questions relating to the new Part 5 amendments please email TGA.Laboratories@health.gov.au