Australia TGA Plans GCP Inspection Program


Australia’s Therapeutic Goods Administration (TGA) plans a GCP inspection program to support Australia’s position as a high quality worldwide hub for clinical research.  TGA is Australia’s regulatory body for therapeutic goods (medicines, medical devices, gene technology and blood products). A part of the Australian Department of Health established under the Therapeutic Goods Act 1989, it is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are an acceptable standard and that access to therapeutic advances occurs in a timely manner.

Seeking to run a GCP pilot program as a path toward a permanent systematized inspection program that ensures the highest quality research occurs in Australia. Presently, Australian clinical trials are approved by the approving Human Research Ethics Committee (HREC).  This differs from global peers where the regulatory agency also greenlights investigational research. So, in Australia there may be some speed, cost and access benefits with the current model but deprivation of TGA powers as compared to global peers poses risk as well.  TGA doesn’t have a routine GCP inspection program.

As the Australian government seeks more clinical research investment it seeks to address its lack of routine GCP inspection program. A voluntary pilot program, investigator sites will be inspected over a 12-month period with a goal to obtain feedback as well as develop systems that support an ongoing GCP inspection program.

Seeking greater position in the global research ecosystem, TGA thus far has designed its proposed pilot program on the European Medicines Agency’s GCP inspections. TGA seeks feedback on its proposals till February 22, 2019.