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Newsletters & articles
The TGA publishes a number of newsletters and articles.
Journals and newsletters
- Medicines Safety Update
Practical information and advice on drug safety and emerging safety issues - Medical Devices Safety Update
Medical device safety bulletin
Articles
2021
- TGA grants provisional determination to Moderna Australia for COVID-19 vaccine SPIKEVAX for proposed use in children – and booster dose under evaluation
10 November 2021: The TGA granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine SPIKEVAX for proposed use in children. The TGA is also evaluating SPIKEVAX for use as a booster dose. - TGA approves booster doses of the Pfizer COVID-19 vaccine, COMIRNATY
27 October 2021: The TGA granted provisional approval to Pfizer Australia Pty Ltd in relation to the booster dose of COVID-19 Vaccine, COMIRNATY, for use in individuals aged 18 years and over. - TGA grants provisional determination for the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in children aged 5 to 11 years
13 October 2021: The TGA granted provisional determination to Pfizer Australia Pty Ltd in relation to the COVID-19 Vaccine, COMIRNATY for use in children aged 5 to 11 years. - TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran
24 June 2021: The TGA granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran. - Have your say on the new TGA website
23 June 2021: Complete a short survey telling us about your experiences of using the existing site - Update to the Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System
22 April 2021: The TGA have made some changes to the SAS & AP Authorised Prescriber Online System - TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment - SOTROVIMAB
14 April 2021: The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods (ARTG). - Seeking volunteers: Good Clinical Practice Inspection Program
25 January 2021: Calling for volunteers to the TGA's GCP Inspection Program in 2021 - Batch release assessment of COVID-19 vaccines
25 January 2021: Information about the batch release assessment process for COVID-19 vaccines - ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
22 January 2021: Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients - COVID-19 vaccine provisional determinations
20 January 2021: The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines - TGA grants additional provisional determination for a COVID-19 vaccine
20 January 2021: The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373
2020
- Updates to the Database of TGA laboratory testing results
7 December 2020: New results have been published - TGA grants third provisional determination for a COVID-19 vaccine
18 November 2020: On 16 November 2020 the TGA granted a provisional determination to Janssen in relation to its COVID-19 vaccine, Ad26.COV2.S - Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020: The name change more accurately reflects the nature of the scheme - TGA grants second provisional determination for a COVID-19 vaccine
14 October 2020: The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA] - TGA grants provisional determination for COVID-19 vaccine
9 October 2020: The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant] - Information for medicine advertisers: Additional allergen warnings effective 1 September 2020
7 September 2020: Additional mandatory health warnings for medicines containing specific allergens are required in certain advertising from 1 September 2020 - TGA Laboratories: What we test and how to access the results
21 July 2020: The TGA Laboratories perform a range of activities to ensure therapeutic goods are of an acceptable standard - Critical medicines supply modelling supports return to elective surgery
3 June 2020: New modelling demonstrates that supply of critical medicines for ventilating patients supports a return to elective surgery - TGA to permit conditional substitution to ease serious shortages
24 April 2020: In response to the COVID-19 pandemic, the TGA is implementing Serious Shortage Medicine Substitution Notices - TGA to expand quality audits for medicinal cannabis
11 March 2020: In the coming months, the TGA will expand the number of quality audits of medicinal cannabis products imported or supplied under the Special Access Scheme (SAS) and other unapproved product access pathways - Brexit - Implications for therapeutic goods in Australia
25 February 2020: Updated advice on implications of Brexit for therapeutic goods supply in Australia - Application to reduce the deferral period for some blood donors under consideration
14 February 2020: The TGA is evaluating an application which proposes to reduce the deferral period for donors with a sexual activity-based risk factor - New science strategy prepares regulatory scientists for the future
20 January 2020: The Health Products Regulation Group has published a new regulatory science strategy
2019
- New Therapeutic Goods (Declared Goods) Order 2019
28 October 2019: The Order consolidates within a single instrument all declarations formerly made under section 7 of the Act - Tabling of Report on the Review into the 2016 Medicinal Cannabis amendments to the Narcotic Drugs Act 1967
5 September 2019: Professor McMillan's Final Report on the Review of the Act was tabled in Parliament on Thursday 5 September 2019 - The TGA launches new tool to help sponsors find information on registering prescription medicines
3 September 2019: This tool allows users to find guidance documents, forms and other resources relating to registering prescription medicines - Consumer fact sheet: recall of Allergan Biocell breast implants
3 September 2019: A fact sheet to support consumers following a recall of Allergan Biocell breast implants has been published - An Action Plan for Medical Devices
4 April 2019: An 'Action Plan for Medical Devices' was released on 4 April 2019. The Action Plan will further improve Australia's medical device regulatory system and place patient safety first.
2018
- 2018 survey results: TGA trusted but not yet a household name
20 December 2018: 2018 TGA stakeholder survey reports available - Therapeutic Goods (Microbiological Standards for Medicines)(TGO 100) Order 2018
12 December 2018: TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98 - Comparable Overseas Reports (COR-A) pathway - First registration decision
2 November 2018: Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway - Adverse event reporting made easier for GPs - Template forms now available
18 October 2018: These templates can be installed in GP's desktop software to make it easier and more convenient for them to report ADRs to the TGA - TGO 98 Microbiological Standards for Medicines (2018)
2 October 2018: TGO 98 has been registered on the Federal Register of Legislation. It commences on 1 October 2018, succeeding TGO 77 - Research: Software as a Medical Device and Cyber Security for Medical Devices
7 August 2018: Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance
Older, revoked and superseded articles are available in the TGA Internet site archive.