AusBiotech welcomes the Therapeutic Goods Administration's (TGA) confirmation that the Clinical Trials Notification (CTN) and Clinical Trials Approval (CTA) pathways remain unchanged, following consultation on 'proposed changes for clinical trials of medical devices'.
"Inclusion of medical device clinical trials in the existing GCP inspection programme is supported by industry, and furthers strengthens trust in Australia's medical device clinical trials ecosystem domestically and globally."
Australia's bio-medical technology industry is supportive of the TGA's risk-based regulatory approach where regulation is commensurate with the risks posed by the therapeutic good to best protect and advance public health.
A thorough process is already in place for assessing risk, with Australia's world-class regulation in place to best protect patients. Whilst, over time, medical devices have increased in their complexity with advances in technology such as the materials used (including 3D printed materials), and the interaction with software, patient safety remains at the heart of the existing processes and is provided for through Australia's existing scientific and ethical review system, along with the mandatory safety reporting requirements of the TGA.
Under the CTN scheme, scientific and ethical review is delegated to and provided by a human research ethics committee (HREC), with subsequent notification to the TGA. Under the CTA scheme, the TGA has a direct role in the review of trial scientific data and must give an 'approval' for the proposed trial programme to go ahead; however, HREC review is still required.
The TGA also recommended that medical devices be included in the current GCP Inspection Program, 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. Historically only medicines and biologicals had been regulated under the GCP programme in Australia.
AusBiotech thanks its Clinical Trial Advisory Group, AusMedtech Advisory Group and AusMedtech Regulatory Affairs Advisory Group for contributing to its advocacy activities during this period.
Read AusBiotech's joint submission here.
