444:
504:
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29:
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142:, 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
405:, 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.
458:
8 March. On 5 March 2021, Italy stopped the export of AstraZeneca vaccine to
Australia due to their slower rollout of that vaccine in the EU. 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.
1146:
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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
428:
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
500:, 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.
329:
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.
457:
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. Two weeks later, on 28 February, the first shipment of the vaccine, around 300,000 doses, arrived at Sydney for rollout from
408:
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
1086:
1138:
420:
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.
523:
472:
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.
173:(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.
409:
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.
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1236:
1021:
424:
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.
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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
342:
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
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897:
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1013:
1349:
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1379:
1139:"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"
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1443:
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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.
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170:
857:
1438:
927:
858:"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"
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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
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465:(ATAGI), the vaccine was no longer recommended for people aged under 60 years. This advice came after new cases of blood clotting,
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346:, the national regulator in New Zealand. In June 2011, eight years after the original treaty, Australian Prime Minister
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to cooperate on medicine regulation and that the New Zealand Government would still participate in the now defunct,
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On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19 vaccine access for five to 11-year-olds.
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vaccine was approved by the TGA (still pending ATAGI approval) as booster vaccines for individuals – joining
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603:
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169:
In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, by the
443:
432:
On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for teenagers between 12 and 15 years old.
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The ODC is entirely under the Office of Drug Control branch within the Health Products Regulation Group.
729:
144:
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
497:
381:
339:
135:
59:
955:
1169:"Australian children aged five to 11 set to receive Pfizer Covid vaccine from mid-January"
8:
1316:"Federal government projects little need for AstraZeneca COVID-19 vaccine after October"
28:
477:
1285:"Australian drug regulator releases first batches of locally made AstraZeneca vaccine"
389:
1014:"Second shipment of Pfizer COVID-19 arrives in Australia, boosting national supply"
888:"TGA provisionally approves Pfizer/BioNTech COVID-19 vaccine for use in Australia"
416:
actually took place on 21 February 2021 with the Pfizer–BioNTech vaccine at
161:
before they can be imported, supplied, exported or manufactured in Australia.
1422:
347:
1045:"Australia secures additional Pfizer vaccine following AstraZeneca concerns"
699:
1346:"TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose"
849:
164:
789:
91:
Professor Tony Lawler, Deputy Secretary, Health Products Regulation Group
984:"COVID-19 vaccines begin as Prime Minister receives Pfizer immunisation"
354:
signed a letter of intent, reaffirming plans to create such an agency.
16:
Medicine and therapeutic regulatory agency of the Australian Government
1079:"AstraZeneca COVID-19 vaccine not recommended to Australians under-60"
951:"When will I get the coronavirus vaccine? Who gets the vaccine first?"
573:
385:
Wordmark of the Australian Government's COVID-19 vaccination program.
1372:"TGA grants third provisional approval to COVID-19 vaccine: Janssen"
759:
669:
1307:
639:
351:
496:
On 25 June 2021, provisional approval was given by the TGA to the
517:
485:
343:
920:"COVID-19 vaccine: Pfizer Australia – COMIRNATY BNT162b2 (mRNA)"
397:
On 25 January 2021, the TGA provisionally approved the two-dose
481:
333:
1109:"TGA approves Pfizer COVID-19 vaccine for 12 to 15-year-olds"
1072:
1070:
365:
1199:"AstraZeneca COVID-19 vaccine approved for use in Australia"
820:"Australia New Zealand Therapeutic Products Agency (ANZTPA)"
529:
Standard for the Uniform Scheduling of Medicines and Poisons
507:
Johnson & Johnson COVID-19 vaccine developed by Janssen
134:) is the medicine and therapeutic regulatory agency of the
1229:"First shipment of AstraZeneca vaccine lands in Australia"
1067:
1259:"EU, Italy stop AstraZeneca vaccine exports to Australia"
469:(TTS), in those under 60 after AstraZeneca vaccinations.
1036:
604:"Therapeutic Goods Administration Business Plan 2020–21"
165:
Structure of the TGA and medical regulation in Australia
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booster vaccines for individuals approved months ago.
1413:
1406:
1101:
159:
Therapeutic Goods (Medical Devices) Regulations 2002
113:
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Medical and health organisations based in Australia
1407:
Official website – Therapeutic Goods Administration
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Australian Technical Advisory Group on Immunisation
177:Structure of the Health Products Regulation Group
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1364:
1439:Commonwealth Government agencies of Australia
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438:
304:Vaping Implementation and Enforcement Branch
218:Complementary and Over-the-counter Medicines
982:Dye, Josh; Clun, Rachel (21 February 2021).
632:
1042:
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334:Proposed regulation agency with New Zealand
447:Oxford AstraZeneca COVID-19 vaccine (2021)
376:
366:COVID-19 vaccine approval and distribution
27:
1414:Official website - Office of Drug Control
467:thrombosis with thrombocytopenia syndrome
1076:
520:, New Zealand's health regulation agency
502:
476:On 9 February 2022 within Australia the
442:
388:
380:
1429:Government agencies established in 1989
1322:. Australian Broadcasting Corporation.
1051:. Australian Broadcasting Corporation.
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1421:
1313:
740:from the original on 16 September 2022
338:In September 2003, the Australian and
1449:National agencies for drug regulation
1352:from the original on 12 February 2022
1024:from the original on 24 February 2021
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800:from the original on 28 February 2021
584:from the original on 28 February 2021
210:Prescription Medicines Authorisation
1382:from the original on 14 October 2021
1179:from the original on 8 December 2021
1149:from the original on 7 December 2021
868:from the original on 29 January 2021
830:from the original on 1 February 2021
770:from the original on 16 January 2021
710:from the original on 24 January 2021
680:from the original on 25 January 2021
650:from the original on 15 January 2021
620:from the original on 1 February 2021
250:Medical Devices and Product Quality
1464:Regulatory authorities of Australia
1043:Worthington, Brett (9 April 2021).
453:Oxford–AstraZeneca COVID-19 vaccine
13:
1295:from the original on 28 March 2021
155:Therapeutic Goods Regulations 1990
140:Department of Health and Aged Care
103:Department of Health and Aged Care
14:
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1326:from the original on 23 June 2021
1239:from the original on 7 March 2021
1119:from the original on 23 July 2021
1089:from the original on 24 June 2021
963:from the original on 11 June 2021
949:Hitch, Georgia (7 January 2021).
900:from the original on 11 June 2021
644:Therapeutics Goods Administration
534:COVID-19 vaccination in Australia
414:COVID-19 vaccination in Australia
372:COVID-19 vaccination in Australia
360:Council of Australian Governments
1434:1989 establishments in Australia
1209:from the original on 5 June 2021
1055:from the original on 2 June 2021
994:from the original on 25 May 2021
930:from the original on 9 June 2021
924:Therapeutic Goods Administration
824:Therapeutic Goods Administration
794:Therapeutic Goods Administration
764:Therapeutic Goods Administration
734:Therapeutic Goods Administration
704:Therapeutic Goods Administration
674:Therapeutic Goods Administration
611:Therapeutic Goods Administration
578:Therapeutic Goods Administration
399:Pfizer–BioNTech COVID-19 vaccine
285:Regulatory Practice and Support
128:Therapeutic Goods Administration
22:Therapeutic Goods Administration
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1077:Coughlan, Matt (17 June 2021).
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350:and New Zealand Prime Minister
862:New Zealand Government Beehive
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393:Pfizer–BioNTech vaccine (2021)
253:Medical Devices Authorisation
1:
1454:Regulation of medical devices
1314:Haydar, Nour (24 June 2021).
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261:Medical Devices Surveillance
7:
511:
10:
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450:
439:Oxford–AstraZeneca vaccine
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199:Regulatory Legal Services
196:Regulatory Legal Services
151:Therapeutic Goods Act 1989
145:Therapeutic Goods Act 1989
988:The Sydney Morning Herald
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242:International Regulatory
206:
108:
98:
84:
73:
65:
55:
40:
35:
26:
700:"What the TGA regulates"
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498:Janssen COVID-19 vaccine
492:Janssen COVID-19 vaccine
202:Dr Bridget Gilmour-Wals
377:Pfizer–BioNTech vaccine
296:Digital Transformation
288:Office of Drug Control
1459:Life sciences industry
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448:
394:
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340:New Zealand Government
320:Regulatory Engagement
312:Regulatory Compliance
277:Manufacturing Quality
226:Scientific Evaluation
171:Office of Drug Control
574:"Working for the TGA"
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446:
392:
384:
237:Dr Claire Larter A/g
207:Medicines Regulation
136:Australian Government
60:Australian Government
1235:. 28 February 2021.
1205:. 16 February 2021.
1143:Department of Health
1113:Department of Health
1020:. 23 February 2021.
893:Department of Health
856:(21 November 2014).
613:. 2020. p. 10.
1348:. 9 February 2022.
1145:. 5 December 2021.
926:. 25 January 2021.
896:. 25 January 2021.
646:. 16 October 2020.
245:Dr Michael Wiseman
181:
23:
790:"Other committees"
736:. 29 August 2024.
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478:Oxford-AstraZeneca
449:
395:
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315:Tracey Lutton A/g
234:Pharmacovigilance
229:Dr George Vukovic
176:
21:
1291:. 23 March 2021.
854:Coleman, Jonathan
580:. 15 April 2016.
412:The first public
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280:Jennifer Burnett
264:Dr Marcelle Noja
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138:. As part of the
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1384:. Retrieved
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1289:The Guardian
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1173:The Guardian
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1083:7NEWS.com.au
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763:
760:"Committees"
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