One-stop shop for clinical trials enters its second phase


The Australian Commission on Safety and Quality in Health Care’s (The Commission) clinical trials ‘National One-Stop Shop’ consultation has opened its second phase for health-related human research approvals.

In support of the work being undertaken by the federal government, AusBiotech continues to champion the industry’s voice as it works with its Clinical Trials Advisory Group and the R&D Taskforce throughout the consultation process. AusBiotech members are invited to unite and have their say as AusBiotech considers:

  • The proposed single national Site-Specific Assessment (SSA) core elements; and,
  • A high-level interactive prototype of the single and nationally-focused health and human research approvals platform, which will be demonstrated and further tested through the second phase of consultations.

The goal of the National One-Stop-Shop and National Clinical Trials Front Door will improve the coordination, and harmonisation across jurisdictions, and offer a single point of access to the sector. This will make it easier for industry, patients, and researchers, to find, conduct, participate, and invest in Australia’s high-quality research. This consultation presents an exciting opportunity to make changes across the entire clinical trials landscape.

AusBiotech has supported the concepts of a National One-Stop Shop and a National Clinical Trials Front Door since they were mooted more than two years ago, through national and international speaking opportunities, formal submissions, and its ongoing discussions with Ministers and departmental staff.

AusBiotech is dedicated to promoting Australia globally as a key destination to conduct clinical trials, and a well-designed National One-Stop Shop will be instrumental in supporting this mission. Its Biotechnology Blueprint outlines how ‘Australia has lots to boast about and our reputation is growing. From our reliable research sector to our world-leading hospital system, and reliable clinical trials sector, to our R&D capabilities and notable expertise, the success of Australian biotechnology is an important story to share when demonstrating the value of companies from across the globe establishing in Australia.’

Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy - demonstrating its value in supporting the country’s transition from a post-mining boom.

AusBiotech members are encouraged to submit their feedback to Karen Parr by Friday 24 June 2022.

For more information on The National One-Stop Shop consultation, click here.