The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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 credible.
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:
Medicines and biologicals
You should refer to the current version of the ICH GCP E6.
Medical devices
- International Organisation for Standardisation (ISO) 14155 – Clinical Investigation of Medical Devices for Human Subjects – Good Clinical practice (ISO 14155).
You should refer to the current version of ISO 14155. Sites will need to obtain their own copy of ISO 14155 which may incur a cost. We cannot provide a copy of this standard.
GCP Inspection Guidance
We have published Preparing for Good Clinical Practice (GCP) inspections Guidance which describes:
- the type of inspections we may conduct
- who we inspect
- how we prioritise and schedule GCP inspections
- how to prepare for an inspection
- the inspection process, and
- how we report and follow-up on inspection.