The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government.[4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods). Therapeutic goods include goods that are represented to have a therapeutic effect, are included in a class of goods the sole or principal use of which is (or ordinarily is) a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the Therapeutic Goods Act 1989.[5] Goods that are therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG), or otherwise be the subject of an exemption, approval or authority by the TGA under the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 or Therapeutic Goods (Medical Devices) Regulations 2002 before they can be imported, supplied, exported or manufactured in Australia.
 | |
| Agency overview | |
|---|---|
| Formed | 1989 |
| Jurisdiction | Australian Government |
| Employees | 750 (2016)[1] |
| Annual budget | A$170 million (2020–21)[2] |
| Agency executive |
|
| Parent department | Department of Health and Aged Care |
| Website | tga |
Structure of the TGA and medical regulation in Australia
editIn Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, by 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 14 regulatory branches and one legal branch, organised into four divisions.
| Division name | Branch name | Head |
|---|---|---|
| Regulatory Legal Services | Regulatory Legal Services | Dr Bridget Gilmour-Wals |
| Medicines Regulation | Prescription Medicines Authorisation | Andrew Simpson |
| Complementary and Over-the-counter Medicines | Dr Cheryl McRae | |
| Scientific Evaluation | Dr George Vukovic | |
| Pharmacovigilance | Dr Claire Larter A/g | |
| International Regulatory | Dr Michael Wiseman | |
| Medical Devices and Product Quality | Medical Devices Authorisation | John Jamieson |
| Medical Devices Surveillance | Dr Marcelle Noja | |
| Laboratories | Dr Lisa Ker | |
| Manufacturing Quality | Jennifer Burnett | |
| Regulatory Practice and Support | Office of Drug Control[a] | Avi Rebera |
| Digital Transformation | Terri Dreyer | |
| Vaping Implementation and Enforcement Branch | Nicole McLay | |
| Regulatory Compliance | Tracey Lutton A/g | |
| Regulatory Engagement | Sarah Syme |
The TGA also includes seven specialised statutory committees, which the agency can call upon for assistance on technical or scientific issues.[7] Four other committees also exist to give guidance on annual influenza vaccines, industry consultation matters, and the Therapeutic Goods Advertising Code.[8]
Proposed regulation agency with New Zealand
editIn 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.[9]
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.[10]
COVID-19 vaccine approval and distribution
editPfizer–BioNTech vaccine
edit
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).[11] Additionally, every batch of vaccines have their composition and documentation verified by TGA laboratories before being distributed to medical providers.[12]
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.[13]
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.[14]
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.[15]
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.[16][17]
On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old.[18]
On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19 vaccine access for five to 11-year-olds.[19][20]
Oxford–AstraZeneca vaccine
edit_I_(cropped).jpg)
On 16 February 2021, the Oxford–AstraZeneca vaccine was approved by the TGA for use in Australia. The administration of this vaccine was scheduled to start in March.[21] Two weeks later, on 28 February, the first shipment of the vaccine, around 300,000 doses, arrived at Sydney for rollout from 8 March.[22] On 5 March 2021, Italy stopped the export of AstraZeneca vaccine to Australia due to their slower rollout of that vaccine in the EU.[23] On 23 March, TGA approved the first batch of locally manufactured AstraZeneca vaccine by CSL-Seqirus in Melbourne, and 832,200 doses were ready for rollout in the following weeks.[24]
On 17 June 2021, Federal Health minister Greg Hunt announced a rise in the age limit for administration of the AstraZeneca vaccine. After new advice from the Australian Technical Advisory Group on Immunisation (ATAGI), the vaccine was no longer recommended for people aged under 60 years. This advice came after new cases of blood clotting, thrombosis with thrombocytopenia syndrome (TTS), in those under 60 after AstraZeneca vaccinations.[17]
On 23 June 2021, the Federal government released vaccine allocation projections and forecast that the Oxford-AstraZeneca vaccine would be in "little need" past October 2021 when all Australians over 60 years were expected to be fully vaccinated.[25]
On 9 February 2022 within Australia the Oxford-AstraZeneca vaccine was approved by the TGA (still pending ATAGI approval) as booster vaccines for individuals – joining Pfizer and Moderna booster vaccines for individuals approved months ago.[26]
Janssen COVID-19 vaccine
editOn 25 June 2021, provisional approval was given by the TGA to the Janssen COVID-19 vaccine, the third vaccine for potential use in Australia. Strict conditions were imposed on Janssen which includes further investigation documents related to the efficacy, long term effects and safety concerns that must be provided regularly to TGA. It is still[when?] not included in the vaccination programme.[27]
See also
editNotes
edit- ^ The ODC is entirely under the Office of Drug Control branch within the Health Products Regulation Group.
References
edit- ^ "Working for the TGA". Therapeutic Goods Administration. 15 April 2016. Archived from the original on 28 February 2021. Retrieved 25 January 2021.
- ^ "Therapeutic Goods Administration Business Plan 2020–21" (PDF). Therapeutic Goods Administration. 2020. p. 10. Archived (PDF) from the original on 1 February 2021. Retrieved 25 January 2021.
- ^ "Structure". Therapeutics Goods Administration. 16 October 2020. Archived from the original on 15 January 2021. Retrieved 25 January 2021.
- ^ "TGA basics". Therapeutic Goods Administration. Archived from the original on 25 January 2021. Retrieved 25 January 2021.
- ^ "What the TGA regulates". Therapeutic Goods Administration. Archived from the original on 24 January 2021. Retrieved 25 January 2021.
- ^ "TGA structure". Therapeutic Goods Administration. 29 August 2024. Archived from the original on 16 September 2022. Retrieved 23 September 2024.
- ^ "Committees". Therapeutic Goods Administration. Archived from the original on 16 January 2021. Retrieved 25 January 2021.
- ^ "Other committees". Therapeutic Goods Administration. Archived from the original on 28 February 2021. Retrieved 25 January 2021.
- ^ "Australia New Zealand Therapeutic Products Agency (ANZTPA)". Therapeutic Goods Administration. Archived from the original on 1 February 2021. Retrieved 25 January 2021.
- ^ Dutton, Peter; Coleman, Jonathan (21 November 2014). "Joint statement by Hon Peter Dutton MP, Minister for Health for Australia, and Hon Dr Jonathan Coleman, Minister of Health for New Zealand, regarding ANZTPA". New Zealand Government Beehive. Archived from the original on 29 January 2021. Retrieved 25 January 2021.
- ^ "TGA provisionally approves Pfizer/BioNTech COVID-19 vaccine for use in Australia". Department of Health. 25 January 2021. Archived from the original on 11 June 2021. Retrieved 26 January 2021.
- ^ "COVID-19 vaccine: Pfizer Australia – COMIRNATY BNT162b2 (mRNA)". Therapeutic Goods Administration. 25 January 2021. Archived from the original on 9 June 2021. Retrieved 26 January 2021.
- ^ Hitch, Georgia (7 January 2021). "When will I get the coronavirus vaccine? Who gets the vaccine first?". ABC News. Archived from the original on 11 June 2021. Retrieved 26 January 2021.
- ^ Dye, Josh; Clun, Rachel (21 February 2021). "COVID-19 vaccines begin as Prime Minister receives Pfizer immunisation". The Sydney Morning Herald. Archived from the original on 25 May 2021. Retrieved 21 February 2021.
- ^ "Second shipment of Pfizer COVID-19 arrives in Australia, boosting national supply". 9News. 23 February 2021. Archived from the original on 24 February 2021. Retrieved 28 February 2021.
- ^ Worthington, Brett (9 April 2021). "Australia secures additional Pfizer vaccine following AstraZeneca concerns". ABC News. Australian Broadcasting Corporation. Archived from the original on 2 June 2021. Retrieved 24 June 2021.
- ^ a b Coughlan, Matt (17 June 2021). "AstraZeneca COVID-19 vaccine not recommended to Australians under-60". 7NEWS.com.au. AAP. Archived from the original on 24 June 2021. Retrieved 24 June 2021.
- ^ "TGA approves Pfizer COVID-19 vaccine for 12 to 15-year-olds". Department of Health. 23 July 2021. Archived from the original on 23 July 2021. Retrieved 23 July 2021.
- ^ "Melbourne Press Conference with Minister Hunt and Professor John Skerritt, on 5 December 2021, on the TGA provisionally approving Pfizer COVID-19 vaccine for 5 to 11-year-olds". Department of Health. 5 December 2021. Archived from the original on 7 December 2021. Retrieved 5 December 2021.
- ^ "Australian children aged five to 11 set to receive Pfizer Covid vaccine from mid-January". The Guardian. Archived from the original on 8 December 2021. Retrieved 7 December 2021.
- ^ "AstraZeneca COVID-19 vaccine approved for use in Australia". abc.net.au. 16 February 2021. Archived from the original on 5 June 2021. Retrieved 17 February 2021.
- ^ "First shipment of AstraZeneca vaccine lands in Australia". 9NEWS. 28 February 2021. Archived from the original on 7 March 2021. Retrieved 28 February 2021.
- ^ "EU, Italy stop AstraZeneca vaccine exports to Australia". 9NEWS. 5 March 2021. Retrieved 5 March 2021.
- ^ "Australian drug regulator releases first batches of locally made AstraZeneca vaccine". The Guardian. 23 March 2021. Archived from the original on 28 March 2021. Retrieved 23 March 2021.
- ^ Haydar, Nour (24 June 2021). "Federal government projects little need for AstraZeneca COVID-19 vaccine after October". ABC News. Australian Broadcasting Corporation. Archived from the original on 23 June 2021. Retrieved 24 June 2021.
- ^ "TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose". 9 February 2022. Archived from the original on 12 February 2022. Retrieved 12 February 2022.
- ^ "TGA grants third provisional approval to COVID-19 vaccine: Janssen". tga.gov.au. 25 June 2021. Archived from the original on 14 October 2021. Retrieved 6 July 2021.