Following a successful pilot program, the TGA is implementing the ongoing risk-based Good Clinical Practice (GCP) Inspection Program. Presentations and Frequently Asked Questions (FAQs) were published following webinars in May and June 2022.
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 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.