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MedTech industry welcomes clinical trials harmonisation

The Medical Technology Association of Australia (MTAA) has welcomed Health Minister Greg Hunt’s announcement at CEDA this week for a one-stop-shop for ethics approval for clinical trials.

“The medical technology industry has long advocated for national harmonisation of clinical trials and welcomes Minister Hunt’s announcement of a one-stop-shop for ethics approval,” said MTAA CEO Ian Burgess.

“Local clinical trials provide Australian patients with early access to innovative medical devices and treatments and place Australia at the forefront of global advancements of medical technology.

“An active medical device clinical trial environment in Australia will provide local expertise to support Australian start-ups and research groups, accelerating their growth and retaining capability and expertise within Australia,” Mr Burgess said.

For Australia to continue to attract the level of clinical trial activity that it has achieved over the past two decades, it is important that strategies are implemented to enhance the clinical trial environment in Australia including:

  • Reliable, predictable, unified and rapid Site Research Governance
  • A single streamlined ethical review for all studies, irrespective of whether they are conducted in private or public setting and irrespective of phase of study
  • Consistent approaches by States and Territories to support the efficient and cost-effective conduct of studies
  • Establishing an Australian Coordinating Body for Clinical Trials would provide an entity that has the mandate and resources to drive the change needed to improve Australia’s global competitiveness in attracting clinical trials.
  • Supportive and efficient regulatory pathway to transition to commercialisation and reimbursement.

“As we emerge from the COVID-19 crisis, it is more important than ever that we do everything we can to ensure the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community, and we welcome this announcement by Minister Hunt,” Mr Burgess concluded.

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