1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in Australia in relation to Decentralized Clinical Trials (“DCTs”). Australia abides by the regulations set forth by the Therapeutic Goods Administration (TGA) and also aligns itself closely with certain regulations of the European Medicines Agency (EMA). Fully DCTs have not yet been conducted in Australia, however hybrid studies have been conducted with an increasing acceptance of decentralized aspects of study design following the COVID-19 pandemic.

The National Health and Medical Research Council (NHMRC) Guidance has aligned with the European Union’s Clinical Trial Regulations: Regulation EU No 536/2014.