Articles

On 1 December 2021, the TGA granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19.

On 15 October 2021 the TGA granted provisional approval to Roche Products Pty Ltd for its COVID-19 treatment - casirivimab + imdevimab (RONAPREVE) - making it the third COVID-19 treatment to receive regulatory approval in Australia.

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.

Questions to ask the overseas website before prescribing or purchasing a nicotine vaping product.

On 28 March 2018, the Senate Community Affairs References Committee reported on its inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters - external site.

Changes enhance transparency

The TGA is inviting consumers, health professionals, industry and other stakeholders to share their views in our annual stakeholder survey by 27 August 2021.

Information about how sunscreens are approved for supply in Australia and what you will see on sunscreen labels.

The TGA has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (COMIRNATY) in individuals 12 years and older.

We are improving the Medicine Shortages IT System.

Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components

Updated storage conditions for the Pfizer COVID-19 vaccine

The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021

The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.

The TGA is warning consumers about the risks of buying medicinal cannabis products online

The TGA is reminding businesses involved with medicinal cannabis products of their regulatory obligations under the Therapeutic Goods Act 1989

The TGA have made some changes to the SAS & AP Authorised Prescriber Online System.

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.

Updated storage conditions for the Pfizer COVID-19 vaccine

The Scheduling Delegate has decided to seek further advice in relation to psilocybin and MDMA

Sunscreen SPF testing by AMA Laboratories - Regulatory update. Possible fraudulent testing of sunscreens and TGA efforts to mitigate effect on Australian consumers.

A new standard, TGO 106, commences in January 2023 to provide clarity to sponsors serialising medicines or using data matrix codes.