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The Therapeutic Goods Administration (TGA) has robust and flexible regulatory processes designed to support acceptable standards of safety, quality and efficacy for products included in the Australian Register of Therapeutic Goods (ARTG).
While we are making every effort to expedite the availability of one or more vaccines to protect against COVID-19, these standards will not be compromised.
On this page you will find links to information and guidance about the relevant regulatory requirements and processes for sponsors and prospective sponsors of COVID-19 vaccines.
The provisional registration pathway
Provisional registration is a special pathway that provides a formal and transparent mechanism for speeding up entering a therapeutic good on the ARTG under certain circumstances. The first step in this process is obtaining a provisional determination from the TGA. Further information on the eligibility criteria can be found at: Provisional determination: A step-by-step guide for prescription medicines.
General information about regulation of prescription medicines
General information about the regulation of prescription medicines in Australia for sponsors is available at: Industry: Prescription medicines. This includes information about standards and regulatory requirements, as well as links to online services and forms, legislation and other resources.
Information about COVID-19 vaccine strain updates
General information describing how the TGA intends to review applications for registration of mRNA vaccines which are variations on existing mRNA vaccines designed to confer protection from newly identified variants of concern is available on the COVID-19 strain updates guidance page.
Information and resources relating to COVID-19
Information and resources relating to COVID-19 have been published on our COVID-19 hub.