The history of drug and substance control in Australia can be traced back to before 1938, and through an evolution of changes led to the establishment in 1990 of the national Therapeutics Goods Administration (TGA). This Federal Department of Health regulatory body was set up to “safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods”, overviewing quality, safety and efficacy of therapeutic goods as a regulator and watchdog for both premarket and post-market pharmacovigilance. [1]