Therapeutic Goods Administration Explained

Jurisdiction:Australian Government
Employees:750 (2016)[1]
Budget: (202021)[2]
Chief1 Name:Professor Tony Lawler
Chief1 Position:Deputy Secretary, Health Products Regulation Group[3]
Parent Department:Department of Health and Aged Care

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 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.[5]

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.

Structure of the Health Products Regulation Group (October 2020)!Division name!Branch name!Head
Not in a divisionRegulatory Legal ServicesJenny Francis
Medicines RegulationPrescription Medicines AuthorisationGrant Pegg
Complementary and Over-the-counter MedicinesCheryl McRae
Scientific EvaluationMichael Wiseman
Pharmacovigilance and Special AccessElspeth Kay
Medical Devices and Product QualityMedical Devices AuthorisationMeryl Clarke
Medical Devices SurveillanceKate McCauley
LaboratoriesLisa Ker
Manufacturing QualityBen Noyen
Regulatory Practice and SupportRegulatory Services and Drug ControlGeorge Masri
Regulatory ComplianceNicole McLay
Regulatory Engagement, Education and PlanningAvi Rebera
The TGA also includes seven specialised statutory committees, which the agency can call upon for assistance on technical or scientific issues.[6] Four other committees also exist to give guidance on annual influenza vaccines, industry consultation matters, and the Therapeutic Goods Advertising Code.[7]

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.[8]

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.[9]

COVID-19 vaccine approval and distribution

See also: COVID-19 vaccination in Australia.

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).[10] Additionally, every batch of vaccines have their composition and documentation verified by TGA laboratories before being distributed to medical providers.[11]

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.[12]

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.[13]

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.[14]

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.[15]

On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old.[16]

On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19 vaccine access for five to 11-year-olds.[17] [18]

Oxford–AstraZeneca vaccine

See main article: Oxford–AstraZeneca COVID-19 vaccine. 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.[19] Two weeks later, on 28 February, the first shipment of the vaccine, around 300,000 doses, arrived at Sydney for rollout from 8 March.[20] On 5 March 2021, Italy stopped the export of AstraZeneca vaccine to Australia due to their slower rollout of that vaccine in the EU.[21] 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.[22]

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.[23]

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.[24]

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.[25]

Janssen COVID-19 vaccine

On 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 not included in the vaccination programme.[26]

See also

External links

Notes and References

  1. Web site: 15 April 2016 . Working for the TGA . live . 25 January 2021 . Therapeutic Goods Administration . 28 February 2021 . https://web.archive.org/web/20210228044126/https://www.tga.gov.au/working-tga .
  2. Web site: 2020. Therapeutic Goods Administration Business Plan 202021. live. 25 January 2021. Therapeutic Goods Administration. 10. 1 February 2021. https://web.archive.org/web/20210201133521/https://www.tga.gov.au/sites/default/files/tga-business-plan-2020-21.pdf.
  3. Web site: 16 October 2020 . Structure . live . 25 January 2021 . Therapeutics Goods Administration . 15 January 2021 . https://web.archive.org/web/20210115214602/https://www.tga.gov.au/structure .
  4. Web site: TGA basics. live. 25 January 2021. Therapeutic Goods Administration. 25 January 2021. https://web.archive.org/web/20210125020147/https://www.tga.gov.au/tga-basics.
  5. Web site: What the TGA regulates. live. 25 January 2021. Therapeutic Goods Administration. 24 January 2021. https://web.archive.org/web/20210124031722/https://www.tga.gov.au/what-tga-regulates.
  6. Web site: Committees. live. 25 January 2021. Therapeutic Goods Administration. 16 January 2021. https://web.archive.org/web/20210116185951/https://www.tga.gov.au/committees.
  7. Web site: Other committees. live. 25 January 2021. Therapeutic Goods Administration. 28 February 2021. https://web.archive.org/web/20210228035822/https://www.tga.gov.au/other-committees.
  8. Web site: Australia New Zealand Therapeutic Products Agency (ANZTPA). live. 25 January 2021. Therapeutic Goods Administration. 1 February 2021. https://web.archive.org/web/20210201223008/https://www.tga.gov.au/publication/australia-new-zealand-therapeutic-products-agency-anztpa.
  9. Web site: Dutton . Peter . Peter Dutton . Coleman . Jonathan . Jonathan Coleman (politician) . 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 . live . 25 January 2021 . New Zealand Government Beehive . 29 January 2021 . https://web.archive.org/web/20210129183834/https://www.beehive.govt.nz/release/joint-statement-hon-peter-dutton-mp-minister-health-australia-and-hon-dr-jonathan-coleman .
  10. Web site: 25 January 2021 . TGA provisionally approves Pfizer/BioNTech COVID-19 vaccine for use in Australia . live . 26 January 2021 . . 11 June 2021 . https://web.archive.org/web/20210611171457/https://www.health.gov.au/news/tga-provisionally-approves-pfizerbiontech-covid-19-vaccine-for-use-in-australia .
  11. Web site: 25 January 2021 . COVID-19 vaccine: Pfizer Australia – COMIRNATY BNT162b2 (mRNA) . live . 26 January 2021 . Therapeutic Goods Administration . 9 June 2021 . https://web.archive.org/web/20210609120309/https://www.tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-bnt162b2-mrna .
  12. News: Hitch . Georgia . 7 January 2021 . When will I get the coronavirus vaccine? Who gets the vaccine first? . . live . 26 January 2021 . 11 June 2021 . https://web.archive.org/web/20210611143453/https://www.abc.net.au/news/2021-01-07/when-will-i-get-coronavirus-vaccine-australia-rollout/13039598 .
  13. News: Dye . Josh . Clun . Rachel . COVID-19 vaccines begin as Prime Minister receives Pfizer immunisation . 21 February 2021 . The Sydney Morning Herald . 21 February 2021 . en-AU . 25 May 2021 . https://web.archive.org/web/20210525075159/https://www.smh.com.au/politics/federal/covid-19-vaccines-begin-as-prime-minister-receives-pfizer-immunisation-20210221-p574cw.html . live .
  14. News: Second shipment of Pfizer COVID-19 arrives in Australia, boosting national supply . 28 February 2021 . 9News . 23 February 2021 . en-AU . 24 February 2021 . https://web.archive.org/web/20210224220756/https://www.9news.com.au/national/coronavirus-vaccine-second-pfizer-shipment-arrives-in-australia-boosting-rollout/b9f60f8e-7eed-4e1d-ae70-b96478fc7352 . live .
  15. News: Worthington . Brett . Australia secures additional Pfizer vaccine following AstraZeneca concerns . 24 June 2021 . ABC News . Australian Broadcasting Corporation . 9 April 2021 . en-AU . 2 June 2021 . https://web.archive.org/web/20210602213237/https://www.abc.net.au/news/2021-04-09/national-cabinet-astrazeneca-covid-vaccine-clots-rollout/100058440 . live .
  16. Web site: TGA approves Pfizer COVID-19 vaccine for 12 to 15-year-olds . 23 July 2021 . Department of Health . 23 July 2021 . en-AU . 23 July 2021 . https://web.archive.org/web/20210723002052/https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/tga-approves-pfizer-covid-19-vaccine-for-12-to-15-year-olds . live .
  17. Web site: 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. 5 December 2021. Department of Health. 5 December 2021. en-AU. 7 December 2021. https://web.archive.org/web/20211207214737/https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/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. live.
  18. News: Australian children aged five to 11 set to receive Pfizer Covid vaccine from mid-January. The Guardian. 7 December 2021. 8 December 2021. https://web.archive.org/web/20211208100913/https://www.theguardian.com/society/2021/dec/05/australian-children-aged-five-to-11-set-to-receive-pfizer-covid-vaccine-from-mid-january. live.
  19. Web site: 16 February 2021 . AstraZeneca COVID-19 vaccine approved for use in Australia . 17 February 2021 . abc.net.au . en-AU . 5 June 2021 . https://web.archive.org/web/20210605233638/https://www.abc.net.au/news/2021-02-16/coronavirus-astrazeneca-vaccine-approved-for-use-in-australia/13115784 . live .
  20. News: First shipment of AstraZeneca vaccine lands in Australia . 28 February 2021 . 9NEWS . 28 February 2021 . en-AU . 7 March 2021 . https://web.archive.org/web/20210307222325/https://www.9news.com.au/national/coronavirus-astrazeneca-vaccine-first-shipment-lands-in-australia-what-you-need-to-know/c636d9fe-6e50-481b-b335-1f563891ea51 . live .
  21. News: EU, Italy stop AstraZeneca vaccine exports to Australia . 5 March 2021 . 9NEWS . 5 March 2021 . en-AU.
  22. News: Australian drug regulator releases first batches of locally made AstraZeneca vaccine . 23 March 2021 . The Guardian . 23 March 2021 . en-AU . 28 March 2021 . https://web.archive.org/web/20210328105416/https://www.theguardian.com/australia-news/2021/mar/23/australian-drug-regulator-releases-first-batches-of-locally-made-astrazeneca-vaccine . live .
  23. News: Coughlan . Matt . AstraZeneca COVID-19 vaccine not recommended to Australians under-60 . 24 June 2021 . 7NEWS.com.au . AAP . 17 June 2021 . en-AU . 24 June 2021 . https://web.archive.org/web/20210624201050/https://7news.com.au/lifestyle/health-wellbeing/astrazeneca-covid-19-vaccine-set-to-be-recommended-to-australians-over-the-age-of-60-only-making-the-pfizer-jab-more-accessible-for-young-aussies-c-3136916 . live .
  24. News: Haydar . Nour . Federal government projects little need for AstraZeneca COVID-19 vaccine after October . 24 June 2021 . ABC News . Australian Broadcasting Corporation . 24 June 2021 . en-AU . 23 June 2021 . https://web.archive.org/web/20210623233827/https://www.abc.net.au/news/2021-06-23/gov-projects-little-need-for-astrazeneca-after-october-covid19/100239442 . live .
  25. Web site: TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose. 9 February 2022. 12 February 2022. 12 February 2022. https://web.archive.org/web/20220212023321/https://www.tga.gov.au/media-release/tga-provisionally-approves-astrazenecas-covid-19-vaccine-booster-dose. live.
  26. Web site: TGA grants third provisional approval to COVID-19 vaccine: Janssen. 6 July 2021. tga.gov.au. 25 June 2021. 14 October 2021. https://web.archive.org/web/20211014181217/https://www.tga.gov.au/media-release/tga-grants-third-provisional-approval-covid-19-vaccine-janssen. live.

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