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COVID-19 treatments: Provisional determinations

6 May 2022

The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted provisional determinations in relation to COVID-19 treatments.

The granting of a provisional determination means that the TGA has made a decision that relevant sponsors are now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods (ARTG).

Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the treatment will be provisionally approved for inclusion in the ARTG. Provisional determinations are effective for 6 months.

Normally for a treatment to be registered in Australia, a sponsor (usually a pharmaceutical company) is required to submit a complete and comprehensive package of data to the TGA. A formal evaluation is then carried out in multiple stages by technical experts prior to a decision being made.

The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new treatments with preliminary clinical data. To apply for provisional registration, the sponsor must first apply for a provisional determination. Further information on eligibility criteria can be found at: Provisional determination: A step-by-step guide for prescription medicines.

In making its decision to grant these provisional determinations, the TGA considered eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.

Effective date Sponsor Name Regulatory status
4 November 2021 AstraZeneca Pty Ltd tixagevimab and cilgavimab (EVUSHELD) Provisionally approved on 24 February 2022 for pre-exposure prophylaxis only
5 October 2021 Pfizer Australia nirmatrelvir + ritonavir (PAXLOVID) Provisionally approved on 18 January 2022
27 September 2021 Roche Products Pty Ltd tocilizumab (ACTEMRA) Provisionally approved on 1 December 2021
20 August 2021 Celltrion Healthcare Australia Pty Ltd regdanvimab (REGKIRONA) Provisionally approved on 6 December 2021
20 August 2021 Roche Products Pty Ltd casirivimab + imdevimab (RONAPREVE) Provisionally approved on 15 October 2021
9 August 2021 Merck Sharp and Dohme (Australia) Pty Ltd molnupiravir (LAGEVRIO) Provisionally approved on 18 January 2022
13 April 2021 GlaxoSmithKline Australia Pty Ltd sotrovimab (XEVUDY) Provisionally approved on 20 August 2021

a. 6 July 2020

b. 6 May 2022

Gilead Sciences Pty Ltd remdesivir (VEKLURY)

a. Provisionally approved on 10 July 2020 for treatment of individuals over 12 years of age (weighing at least 40 kg) with severe COVID-19 symptoms who have been hospitalised

b. Provisionally approved on 6May 2022 for

  • adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen
  • adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19