Australia: TGA plans GCP inspection program to ensure global recognition of Australian data

17-01-2019

Australia: TGA plans GCP inspection program to ensure global recognition of Australian data

(Source: RAPS 2019-01-17)

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.

GCP inspections are typically seen as a way to enforce compliance. That is one goal of the planned TGA program, too, but the Australian authorities also have a broader, more commercial objective.

“A domestic regulatory GCP inspections program will strengthen Australia as an attractive clinical trial research destination for both the local medical technologies, biotechnology and pharmaceuticals sector ... and in attracting internationally sponsored clinical trials.” TGA wrote. “It will address the potential risk of a decline in international recognition of Australian clinical trial data quality and integrity, and underpin creation of a highly productive commercialization environment.”

TGA has based the design of its proposed pilot program on the European Medicines Agency’s GCP inspections. During the inspections, TGA staff will review clinical trial data, informed consent procedures and other site activities related to GCP compliance.

Inspectors will categorize any deficiencies they identify during their visits as minor, major or critical and recommend remedial actions. TGA plans to share details of serious issues identified during GCP inspections with the HREC or authorizing institution. Compliance powers may be considered if the issues pose a risk to the safety of participants.

Despite that, TGA is framing the pilot program as a collaborative exercise, in part because it recognizes that many of the sites it visits will never have undergone a GCP inspection. TGA therefore wants to use the pilot to educate the sector while refining its processes. TGA will inform sites of the dates of its inspections and will hold open meetings to discuss its plan for each assessment.

If TGA receives positive feedback on the pilot, it plans to start the program in the coming months. Participants in the voluntary program will not pay a fee, with the funding instead coming from TGA’s general charges revenue. In the longer term, TGA notes that most comparable overseas agencies do not charge a fee for GCP inspections, but that expenses for its other services are recovered by fees and charges.

TGA is accepting feedback on the proposals until 22 February.

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