Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

On 1 October 2025, the Therapeutic Goods Administration (TGA) introduced significant amendments to the Therapeutic Goods Regulations 1990, specifically through the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025. These changes primarily focus on enhancing the clarity and functionality of Part 5, which governs the testing of therapeutic goods in Australia. As specialists in Good Manufacturing Practice (GMP) and regulatory compliance, Quality Systems Now recognises the importance of these amendments for therapeutic goods manufacturers, testing laboratories, and biotechnology companies.

Key Amendments to Part 5

1. Authorisation of Analysts

The revised Part 5 empowers the Secretary to nominate Australian Public Service (APS) employees as analysts. These analysts are authorised to select and test samples of therapeutic goods to ensure compliance with the Therapeutic Goods Act 1989 and associated legislation. This change aims to streamline the testing process and ensure that qualified personnel are responsible for conducting tests.

2. Testing by Appropriate Entities

Under the new regulations, testing can be conducted not only by nominated analysts but also by other appropriate persons or bodies. This flexibility allows for a broader range of qualified entities to perform testing, potentially reducing bottlenecks and expediting the regulatory process.

3. Issuance of Testing Certificates

Upon completion of testing, analysts are required to issue a certificate documenting the testing conducted and the results obtained. This certificate may also include additional information relevant to the sample tested or the testing process. The introduction of this formal documentation enhances transparency and provides a clear record of compliance.

4. Transitional Arrangements

To ensure continuity and minimise disruption, transitional arrangements have been put in place. Certain goods obtained by the department prior to the commencement of the amendments may still need to be tested under the previous version of Part 5. These arrangements are designed to accommodate ongoing testing requirements during the transition period.

Implications for Industry Stakeholders

Manufacturers and Sponsors

For manufacturers and sponsors of therapeutic goods, these amendments necessitate a review and potential update of internal quality systems and testing protocols. Ensuring that testing procedures align with the new regulations will be crucial for maintaining compliance and avoiding delays in product approvals.

Testing Laboratories

Testing laboratories must familiarise themselves with the revised Part 5 to understand their roles and responsibilities under the new framework. This includes recognising the expanded scope of entities authorised to conduct testing and the requirements for issuing testing certificates.

Biotechnology Companies

Biotechnology companies developing new therapeutic goods should consider the impact of these regulatory changes on their product development timelines. Early engagement with the TGA and alignment of testing practices with the new regulations can facilitate smoother regulatory interactions and faster time-to-market.

Conclusion

The amendments to Part 5 of the Therapeutic Goods Regulations 1990 represent a significant step towards modernising and streamlining the regulatory framework for therapeutic goods testing in Australia. By enhancing clarity, flexibility, and transparency, these changes aim to support innovation while ensuring the safety and efficacy of therapeutic products.

For companies navigating these changes, Quality Systems Now offers expert guidance in GMP and regulatory compliance. Our team can assist in aligning your quality systems with the new regulations, ensuring that your products meet the required standards for safety and efficacy.

For more detailed information on the amendments, please refer to the official TGA announcement: Therapeutic Goods Legislation Amendment effective from 1 October 2025.