National platform for health and medical research

The Commission is conducting national consultations on behalf of all jurisdictions to scope the requirements for a national health and medical research approvals platform – a National One-Stop-Shop.

 

The concept for the National One-Stop-Shop was developed by the Clinical Trials Project Reference Group and presents a significant opportunity to achieve a national, interconnected, rapid and streamlined approvals platform that will:

  • include a cross-jurisdictional ethics and governance approvals platform that incorporates key application, notification and approval systems
  • incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the Therapeutic Goods Administration 
  • include an embedded and automated next-generation national clinical trials registry
  • provide sophisticated monitoring and reporting functionality for different users.

Options for improving patient recruitment through a related National Clinical Trials Front Door, will also be considered.

The aim is to make it easier for patients, researchers, industry representatives and sponsors to find, conduct, participate and invest in research in Australia.

The consultations will also inform the concept for the related National Clinical Trials Front Door, which will have a strong focus on patient recruitment.

A project advisory group, chaired by Professor Ian Chubb, former Chief Scientist and clinical trial participant, will be established to guide the consultation process.

Consultations commence July 2021

The purpose of the consultations is to scope the national approach, and to gather the requirements for the National One-Stop-Shop and subsequently, the National Clinical Trials Front Door.

Register your interest

Click on the link and complete the required information to receive updates on how to be involved.

If you have any questions relating to this consultation, please contact HMR@safetyandquality.gov.au.