Abstract

Genetically modified organisms (GMOs) are increasingly being used in clinical development. As a result, understanding the Australian regulatory framework governing their use has become progressively more important for regulatory affairs professionals. The Office of the Gene Technology Regulator (OGTR) is the primary authority responsible for regulating GMOs in Australia and its risk-based assessment framework helps ensure that their use remains safe, while enabling the efficient conduct of clinical trials involving GMOs. In the past years, the OGTR has modified its submission process to facilitate the use of investigational GMO products in Australian clinical trials.

This article provides a background to the OGTR’s role in overseeing the use of GMOs in clinical trials, the licence application process, different types of licences and conditions associated with each.