Regulatory changes for medical device clinical trials not needed


Based on flimsy rationale and opposition from medical devices developers, AusBiotech is urging the federal government not to push ahead with the proposed regulatory changes that will see a more onerous approval process for numerous implantable medical device clinical trials - which will cause delays and red tape, but may not enhance patient safety.

Industry united last year through the Research and Development Taskforce (RDTF) to respond to the Therapeutic Goods Administration’s (TGA) consultation on proposed changes for clinical trials of medical devices and make a joint submission on maintaining regulation commensurate with risk.

Patient safety is at the heart of Australia’s existing regulatory processes, and the industry is supportive of the sound patient protection provided through Australia’s existing scientific and ethical review system in place for high-risk devices, along with the TGA’s mandatory safety reporting requirements.

While the industry agrees with the TGA that 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, it contends that these developments do not infer that the risk has increased – as indicated, without evidence, in the consultation paper.

Australia has a thorough process and world-class regulation in place to assess risk and best protect patients, and the RDTF suggested in its submission that implementing the proposed changes will not better protect patients’ health, and equally, it will also disadvantage public health activities.

Overall, the industry supported the TGA’s proposal to include all medical device clinical trials in Australia’s Good Clinical Practice (GCP) Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary for its members and the Australian life science sector.

The RDTF is a multi-sector collaboration between AusBiotech, the Medical Technology Association of Australia and Medicines Australia to thoroughly review the current design of clinical trials oversight, and highlighted in its submission that there is evidence demonstrating that Australia’s current process is safe and efficient for participants in first in human studies.

Together with the RDTF, the response was also developed with AusBiotech’s Clinical Trials Advisory Group, AusMedtech Advisory Group, and AusMedtech Regulatory Affairs Advisory Group, each providing guidance and advice on operational and policy-related regulatory matters.

Read the full submission.