This audit would examine the efficiency and effectiveness of the Therapeutic Goods Administration’s (TGA’s) activities to approve and regulate medicines and medical devices, including the making of representations in advertising.

The emergence of the COVID-19 pandemic resulted in increases in demand for information on, and approval of, therapeutic products including COVID-19 tests, disinfectants, personal protective equipment and medicines. During the first six months of 2020, TGA fielded an increase of more than 200 per cent in general enquiries regarding new medical products. This period also saw an increase in regulated representations being included on goods sold in Australia.