Australia is the most populous country in Oceania, and ranks 55^th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the country’s above-average wealth. Factors such as a skilled workforce, high-quality research infrastructure, government incentives and well developed regulatory and health technology assessment (HTA) frameworks encourage research and development (R&D) activities and continue to make Australia an attractive destination for therapeutic goods sponsors and manufacturers. Australia’s Therapeutic Goods Administration (TGA) sits at the centre of it all.