The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods.
Structure of the TGA and medical regulation in Australia
In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care. The Health Products Regulation Group comprises 11 regulatory branches and one legal branch, organised into three divisions. The Regulatory Services and Drug Control branch is the only one to not be part of the TGA.
The TGA also includes seven specialised statutory committees, which the agency can call upon for assistance on technical or scientific issues. Four other committees also exist to give guidance on annual influenza vaccines, industry consultation matters, and the Therapeutic Goods Advertising Code.
Proposed regulation agency with New Zealand
In September 2003, the Australian and New Zealand Government signed a treaty to establish a common therapeutic regulatory agency for the two countries. Australia New Zealand Therapeutic Products Agency, as it was to be called, would replace the TGA and Medsafe, the national regulator in New Zealand. In June 2011, eight years after the original treaty, Australian Prime Minister Julia Gillard and New Zealand Prime Minister John Key signed a letter of intent, reaffirming plans to create such an agency.
In November 2014, both Australia and New Zealand agreed to cease plans to create a shared regulator, citing "a comprehensive review of progress and assessment of the costs and benefits to each country". The joint statement announcing the cessation outlines that both the TGA and Medsafe would continue to cooperate on medicine regulation and that the New Zealand Government would still participate in the now defunct, Council of Australian Governments Health Council.
COVID-19 vaccine approval and distribution
Pfizer–BioNTech vaccine
On 25 January 2021, the TGA provisionally approved the two-dose Pfizer–BioNTech COVID-19 vaccine, named COMIRNATY, for use within Australia. The provisional approval only recommends the vaccine for patients over the age of 16, pending ongoing submission of clinical data from the vaccine sponsors (the manufacturers, Pfizer and BioNTech). Additionally, every batch of vaccines have their composition and documentation verified by TGA laboratories before being distributed to medical providers.
The Department of Health and Aged Care planned the administration of COVID-19 vaccinations in five phases, organised by the risk of exposure. Border, quarantine, and front-line health and aged care workers were vaccinated first, followed by over 70 year-olds, other health care workers, and essential emergency service members. Following the provisional approval of COMIRNATY, Prime Minister Scott Morrison said that it was planned for the first group to begin vaccinations by February 2021, six weeks earlier than originally planned.
The first public COVID-19 vaccination in Australia actually took place on 21 February 2021 with the Pfizer–BioNTech vaccine at Castle Hill in Sydney. An 84-year-old aged care resident was the first Australian to receive the vaccine. To show confidence in the national immunisation vaccine rollout, Prime Minister Morrison and Chief Medical Officer Professor Paul Kelly also received vaccinations.
On 23 February 2021, Australia's second shipment of the Pfizer vaccine arrived at Sydney airport. Health Minister Hunt confirmed the arrival of 166,000 doses, and 120,000 more doses expected to arrive in the following week.
On 9 April 2021, Prime Minister Morrison announced that Australia had secured another 20 million doses of Pfizer vaccine on top of 20 million already on order, meaning 40 million doses should be available to Australians in 2021. This was amid concerns about the AstraZeneca vaccine, in rare cases, causing blood clots; see section Oxford–AstraZeneca vaccine below. The additional doses of Pfizer were expected to arrive in Australia in the last quarter of 2021.
