TGA Finalises Australian Annotations to ICH E6(R3) Good Clinical Practice Guidelines Following Public Consultation

Background: What the TGA Has Finalised

The Therapeutic Goods Administration (TGA) has finalised its Australian-specific annotations to the International Council for Harmonisation (ICH) E6(R3) guideline for Good Clinical Practice (GCP) following a public consultation process.

The outcomes of the public consultation were finalised on 16 December 2025, delivering a clear and practical framework for clinical trials conducted in Australia.

The consultation received 51 submissions from stakeholders across the clinical research sector. Feedback showed strong support for a 12-month transition period, which the TGA has adopted. ICH E6(R3) takes effect on 13 January 2026, with compliance permitted under either the previous version or E6(R3) until 13 January 2027.

What the Annotations Mean for Sponsors

The annotations provide guidance on applying the international guideline within Australia’s regulatory environment. The annotations do not alter the core ICH text but ensure alignment with local requirements, including the Therapeutic Goods Act 1989 (Cth) and the National Statement on Ethical Conduct in Human Research. Key refinements made in response to consultation feedback include clearer introductory language, additional cross-references to supporting TGA materials, more precise citations to informed consent provisions in the National Statement, updated guidance on record retention periods, and strengthened requirements for trial registration and results dissemination.

These changes enhance usability while maintaining Australia’s rigorous standards for participant protection and scientific integrity.

Practical Implications for Clinical Trial Research Agreements and Indemnity Arrangements

For international pharmaceutical and biotechnology companies conducting trials in Australia, the finalised annotations have important contractual implications.

Note that TGA rules require the sponsor of a clinical trial to be an Australian entity. International companies commonly satisfy this by establishing an Australian-incorporated subsidiary (which can be wholly foreign-owned) or appointing a local organisation, such as a Contract Research Organisation (CRO), to act as the sponsor.

Implications for Contracting (CTRAs)

Clinical Trial Research Agreements (CTRAs), typically based on Medicines Australia standard forms, may require targeted updates. The annotations’ emphasis on informed consent processes and record retention obligations suggests that clauses addressing these areas should explicitly reference the National Statement and applicable retention periods (generally 15 years or longer although longer periods may apply depending on trial type (e.g. paediatric, gene therapy)). Such adjustments help ensure contracts remain compliant and reduce the risk of disputes between sponsors and Australian sites.

Indemnity & Record Retention Considerations

Indemnity arrangements also merit review. The clarified guidance on long-term record retention underscores the need for indemnity and insurance provisions that adequately cover extended liability periods. Sponsors should confirm that their arrangements satisfy both Australian expectations (including National Health and Medical Research Council (NHMRC) guidelines) and home-jurisdiction requirements, avoiding gaps that could delay site activation or expose parties to unnecessary risk.

Transition Period and Next Steps

The 12-month transition period offers a valuable opportunity for sponsors to audit existing Australian CTRAs and indemnity documentation against the new annotations. Early action supports smoother trial execution and reinforces Australia’s appeal as a preferred jurisdiction, bolstered by rapid ethics and governance approvals and the 43.5% R&D tax incentive.

Opportuna Legal provides services in regulatory compliance, contract drafting, and indemnity structuring for clinical trials in Australia. We deliver efficient, commercially sound solutions tailored to the needs of sponsors conducting research in this jurisdiction.

Contact Opportuna Legal for expert assistance with updating CTRAs, sponsor governance processes, and indemnity structures to reflect the Australian ICH E6(R3) annotations.

Anthony Jarvis

Director | Corporate

Opportuna Legal

Anthony Jarvis advises international pharmaceutical and biotechnology companies on Australian clinical trial regulation, Clinical Trial Research Agreements (CTRAs), indemnity arrangements, and sponsor compliance under TGA and NHMRC frameworks.

Contact

Email: reception@opportunalegal.com.au

Telephone: +61 8 6110 3748

Disclaimer: This article provides general information only and does not constitute legal advice. Readers should seek specific professional advice relevant to their circumstances.