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ICH GCP E6(R3): Stay informed on the latest updates to the TGA adoption of ICH E6 (R3) Guideline for Good Clinical Practice at ICH Guideline for Good Clinical Practice.
In 2022, we implemented an ongoing risk-based Good Clinical Practice (GCP) Inspection Program.
Clinical trials of medicines, biologicals and devices, regulated under the Clinical Trial Notification (CTN) scheme or Clinical Trial Approval (CTA) schemes, are within scope of our GCP Inspection Program.
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are reliable.
All clinical trials carried out under the CTN or CTA schemes must be in accordance with the relevant GCP guideline(s). We recognise the following internationally accepted GCP guidelines:
You should refer to the current version of the ICH GCP E6.
We recognise ISO 14155:2026 as the current version. Sites will need to obtain their own copy of ISO 14155 which may incur a cost. We cannot provide a copy of this standard.
ISO 14155:2026 was published in March 2026. To allow stakeholders time to consider the updated requirements, a 12-month transition period applies from the date of publication (31 March 2026 – 31 March 2027).
For device trials conducted in alignment with ISO 14155, sites should review the updated standard to understand the changes introduced in the 2026 version. A summary of the key changes is publicly available within the foreward of ISO 14155:2026.
Where gaps are identified, sites should develop an implementation plan and document how the review was conducted. We do not require the implementation plan to be submitted to the TGA or Human Research Ethics Committee (HREC). However, if the review identifies changes to HREC-approved study documentation, the standard amendment process should be followed prior to implementation. This may include providing sufficient justification and supporting information for the proposed changes to the HREC.
Our expectation is that sites have a plan for implementing the updated requirements and maintain records describing how the review was conducted, the decisions made, and the rationale for those decisions, including any risk-proportionate approaches adopted. These records should be retained in the site file and be available for review during inspection.
We have published Preparing for Good Clinical Practice (GCP) inspections Guidance which describes:
We publish annual GCP metrics reports on inspection findings and compliance expectations. Use the metrics report to help ensure your trial is compliant and ready for an inspection. You can self-assess if similar compliance issues may need to be addressed at your site.
The information published does not identify individual clinical trial sponsor or investigator or investigator site names.
We have developed a series of online learning modules for people who are new to therapeutic goods regulation or who would like to refresh their knowledge of key principles.
Getting Started: TGA's Good Clinical Practice (GCP) Inspection Program provides an overview of the TGA's inspection program, including why inspections are conducted, our scope, and what clinical trial sites can expect during an inspection.
For any GCP-related enquiries, please email GCP.Inspection@health.gov.au.
ISO 14155:2026 and eLearning update
Publication of Good Clinical Practice Inspection Program Metrics Report 2025
Added callout box to link to the ICH Guideline for Good Clinical Practice page.
Publication of Good Clinical Practice Inspection Program Metrics Report 2023 - 2024
ISO 14155:2026 and eLearning update
Publication of Good Clinical Practice Inspection Program Metrics Report 2025
Added callout box to link to the ICH Guideline for Good Clinical Practice page.
Publication of Good Clinical Practice Inspection Program Metrics Report 2023 - 2024
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