Recently last week (30 October, 2024) the TGA released an updated reference material about the "Good Clinical Practice (GCP) Inspection Program". The Good Clinical Practice (GCP) Inspection Program is an initiative by the Therapeutic Goods Administration (TGA) of Australia to ensure that clinical trials conducted in Australia adhere to international standards for Good Clinical Practice (GCP). This program is part of the TGA's commitment to maintaining the highest standards in clinical research, safeguarding participant safety, and ensuring that clinical trial data is reliable and of high quality.
GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Compliance with GCP assures that clinical trial participants' rights, safety, and well-being are protected and that the trial data generated are credible.
In 2022, TGA implemented an ongoing risk-based Good Clinical Practice (GCP) Inspection Program. Clinical trials of medicines, biologicals, and devices regulated under the CTN or CTA schemes are subject to our GCP Inspection Program. All clinical trials carried out under the CTN or CTA schemes must be in accordance with the relevant GCP guideline(s).
The GCP Inspection Program was established to assess and verify compliance with Good Clinical Practice guidelines, which are based on the principles outlined by the International Council for Harmonisation (ICH). The program's goal is to provide confidence in the quality and integrity of clinical trials conducted in Australia by ensuring they meet globally recognized ethical and scientific standards.
The GCP Inspection Program for clinical trials involving medicines, biologicals and devices, describes:
the type of inspections we may conduct
who we inspect
how TGA prioritize and schedule GCP inspections
how to prepare for an inspection
the inspection process, and
how we report and follow-up on inspection.
The TGA conducts inspections across various aspects of clinical trials, including:
Trial Sites: Inspection of trial sites to evaluate compliance with protocol requirements, GCP, and regulatory standards.
Sponsor and Contract Research Organizations (CROs): Inspections may also extend to sponsors and CROs to assess their role in trial oversight and data management.
Documentation: Evaluation of essential documents such as informed consent forms, trial protocols, and monitoring reports to ensure compliance with GCP documentation standards.
For more information, refer to the full guidance document on the TGA’s official website: TGA GCP Inspection Program. Download the GCP inspection guidance: Good Clinical Practice (GCP) inspection program (pdf,247kb)
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