Clinical trial approvals in Australia can be easier or faster if the drug or therapy has already received FDA approval or has been cleared for clinical trials by the FDA. Our govt often pays to have Australian citizens treated in the US for CAR-T therapy at a cost of US$500k per patient. Aust also offers the highest tax rebates for R&D which includes clinical trials.
Australia's regulatory body, the Therapeutic Goods Administration (TGA), often recognizes the rigorous standards of the FDA, which can streamline the approval process for clinical trials. The TGA considers data from FDA-approved clinical trials or decisions, potentially reducing the amount of additional data required for Australian approval.
Australia has a streamlined process called the Clinical Trial Notification (CTN) scheme. Under this scheme, the responsibility for scientific and ethical review of the trial lies with the Human Research Ethics Committee (HREC). If a drug has already undergone FDA review, it may be viewed more favorably by the HREC.Reduced Redundancies.
Prior FDA approval or data can help reduce redundancies in the review process, making it quicker and more straightforward to get approval for clinical trials in Australia. While prior FDA approval can facilitate the process, each application is still reviewed on a case-by-case basis by the relevant Australian authorities, including ethical review committees and the TGA.
