Regulatory And Ethics Approval Of Clinical Trials In Australia
The regulatory framework for the approval of clinical trials of unapproved medicines in Australia is administered by the Therapeutic Goods Administration (TGA) via the Clinical Trials Notification (CTN) Scheme. Notification via the CTN Scheme removes the need for an Investigational New Drug (IND) application with clinical trials able to commence within 7 days of submission of the CTN form to the TGA following ethics approval. A single ethics review system, which allows for ethics approval by one ethics committee across multiple clinical trial centres, has been adopted throughout Australia.
It is a legal requirement that all clinical trials of unapproved medicines in Australia are conducted in accordance with the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
Trial data from clinical trials conducted in Australia is accepted by regulatory agencies worldwide including the US Food and Drug Administration, the European Medicines Agency and the China Food and Drug Administration.