Australia: Updated Clinical Trial Handbook

On March 15, Australia’s Therapeutic Goods Administration (TGA) published a revised version of their Clinical Trial Handbook[i]. The updated handbook provides guidance on the legal framework for conducting clinical trials of unapproved therapeutic products in Australia.

While the handbook does not describe all of the requirements for conducting clinical trials, it is a valuable resource that outlines the steps of the Australian drug approval process. The guidance document also provides links to a wealth of supporting regulatory publications and relevant regulations.

One significant improvement to the handbook is the expanded section on importing and exporting unapproved therapeutic products for clinical trial. The section includes a summary of the rules for: 

  • Import and supply of investigational drugs
  • Export of therapeutic products
  • Retrieval, destruction, and export of unused clinical trial material

The updated Clinical Trial Handbook is a welcome addition to the already plentiful amount of regulatory guidance documents available on the TGA website. It will certainly be a useful reference tool for companies interested in conducting clinical trials in Australia and for those already involved in approved trials.

Reynaldo Roman

Director Regulatory Compliance


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