In 2022, the TGA implemented an ongoing risk-based Good Clinical Practice (GCP) Inspection Program. The findings of the inspection program provide confidence in the quality of Australian clinical trials and their compliance with GCP. The first report of the program, which covers the first six months of the program, has now been published. The report provides insights into inspection findings and compliance expectations.
About the Good Clinical Practice Inspection Program
Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program.
Good Clinical Practice (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.
The TGA publishes annual inspection program metrics reports containing de-identified information on the number of inspections held, the type of inspections, findings and outcomes from inspections. The report provides insights into inspection findings and compliance expectations.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.