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Avoid an IND

In order to conduct a clinical trial in Australia, there are several different steps that need to occur:
New South Wales (NSW) is 5th in the world for biotech capabilities, in the top 10 destinations globally for clinical trials, and home to 55% of Australia’s medtech and biotech companies.

With Australia’s largest population, strongest economy, and innovative life sciences sector, NSW is home to an integrated, world-class health and medical research sector that is solving some of the world’s most complex and burdensome healthcare challenges.
  • There must be an entity which acts as the local representative (local sponsor).
  • That local sponsor, or their delegate, will submit the Protocol, Investigators Brochure, PICF, Pre Clinical Results and other clinical trial material to the Human Research Ethics Committee (HREC), which is equivalent to the IRB for review.
  • Once documentation has been submitted to the HREC, there are two main approval pathways to when engaging the TGA: the Clinical Trial Notification (CTN) or the Clinical Trial Exemption (CTA) schemes.
  • The CTN is by far the most common pathway and accounts for well over 95% of all clinical trial applications in Australia. In this pathway, the scientific and ethical review is conducted by the HREC committee, while the TGA is not involved in review of the nonclinical data. The TGAs is notified of a clinical trial approval, as opposed to providing the approval and is generally completed in as little as 4-8 weeks, depending on cycles of review.
  • The CTA pathway is used significantly less frequently and is involves the TGA conducting a scientific review of your study, and sponsors obtaining formal scientific approval from the TGA. This pathway is almost exclusively used for higher risk studies, often involving cellular or gene therapies and is mandatory for Class 4 biologicals. This pathway is longer and is generally 3-6 months, depending on cycles of review.
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임상 연구에 관심이 있는 한국 과목

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