The Clinical Trial Exemption (CTX) scheme - one of the two avenues available for trials of unapproved therapeutic goods in Australia - has been renamed as the Clinical Trial Approval (CTA) scheme.
The TGA had recently made the change to more accurately reflect the scheme’s purpose. The accompanying Clinical Trial Notification (CTN) scheme remains unchanged.
The overall decision as to whether a CTA or CTN is required is the responsibility of the trial sponsor, and further guidance is available on the TGA’s website (https://www.tga.gov.au/resource/australian-clinical-trial-handbook). Consultation with a Human Research Ethics Committee that will approve the trial protocol may assist in this decision.
The TGA’s website, applications forms and the Australian clinical trial handbook have been updated with the name change.
AusBiotech is dedicated to promoting Australia as a key destination to conduct clinical trials. It is a globally-competitive location, and are worth around $1 billion to the Australian economy annually, including around $650 million of foreign investment, with Australia attracting trials from around the world. They are a critical component in the development process of bringing new therapies, devices and diagnostics to patients.