Australia – TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data

Australia’s Therapeutic Goods Administration (TGA) is planning to run a good clinical practice (GCP) inspection pilot program. TGA sees the pilot as a stepping stone to a permanent, routine inspection program designed to mitigate the risk that recognition of the quality and integrity of clinical trial data generated in Australia will decline internationally.

Clinical trials run in Australia are assessed and green lit by the approving Human Research Ethics Committee (HREC), not TGA. While Australia thinks the model has speed, cost and access benefits, it also recognizes that depriving TGA of powers possessed by its global peers limits the agency’s ability to identify risks over the duration of a study. To compound matters, TGA lacks a routine inspection program to check whether clinical trials comply with GCPs.

Now, with the Australian government working to attract more clinical research to the country, TGA is set to address its lack of a routine GCP inspection program. The planned voluntary pilot program will inspect investigator sites testing medicines over a 12-month period to obtain feedback and develop systems that support an ongoing GCP inspection program…