Find out answers to the common types of questions you may have about how the TGA assesses and monitors a treatment for safety, quality and effectiveness.

What COVID-19 treatment options are under development?

A diverse portfolio of COVID-19 treatments are at various stages of developmentin Australia and internationally, with some in advanced clinical trials and some subject to emergency use authorisation overseas.

Treatments are being developed for a variety of clinical scenarios including:

• early and late stages of COVID-19, including prevention of disease progression
• prophylaxis (prevention) of disease
• hospitalised and non-hospitalised patients
• oral and injectable treatments
• single and multi-dose regimens

One particular focus is on therapies that potentially reduce the risk of disease progression in ‘high-risk’ patients who currently have mild-moderate disease and are currently not hospitalised. Those at higher risk of complications from COVID-19 include elderly and immunosuppressed patients and those with co-morbidities including diabetes, obesity, kidney disease, heart disease or liver disease.

Potential COVID-19 treatments fall into broad categories:

• Antiviral treatments (similar to those used in hepatitis and HIV) which act to stop the SARS-CoV-2 virus multiplying and causing more severe disease.
• Immune modulators which help the immune system to fight COVID-19 and stop it progressing to more serious disease.
• Monoclonal antibody treatments which can prevent the coronavirus entering cells and causing more serious disease.

How is the TGA working with international regulators?

The Therapeutic Goods Administration (TGA) is proactively engaging with local and overseas pharmaceutical companies who have COVID-19 treatments in their development pipeline.

In Australia, COVID-19 treatments that demonstrate promising clinical results are eligible to be fast-tracked through the provisional registration pathway. This mechanism enables early access while ensuring treatments are rigorously evaluated for safety, quality and efficacy subject to confirmatory trials.

The TGA will treat any application for a COVID-19 treatment with the greatest priority.

The TGA is also working very closely with international regulators to harmonise regulatory approaches, share information and where it speeds up evaluation, collaboratively review new treatments.

This includes through the International Coalition of Medicines Regulatory Authorities (ICMRA, of which TGA is vice-chair), the European Medicines Agency OPEN initiative and the ACCESS work-sharing arrangements with Canada, Singapore, Switzerland and the United Kingdom.

How is a COVID-19 treatment approved?

The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 treatments before they can be used in Australia. There are a number of stages in the regulatory process, including:

• pre-application
• application
• evaluation
• decision
• registration
• monitoring.

Applications for COVID-19 treatments can be submitted via the:

• standard registration process (see: Prescription medicines registration process and Australian Regulatory Guidelines for Prescription Medicines (ARGPM)); or
• provisional approval process (similar to that available for COVID-19 vaccines, see: Provisional registration process).

How does the TGA evaluate a treatment?

The Therapeutics Goods Administration (TGA) rigorously assesses therapeutic treatments for safety, quality and efficacy before they can be approved for use and supply in Australia.

A large team of clinical and scientific experts at the TGA undertake a comprehensive review of clinical trial data, non-clinical and toxicological studies, chemistry, manufacturing, quality, risk management and other information. Advice is then sought from an independent expert committee, the Advisory Committee on Medicines, before a regulatory decision is made.

The TGA will only approve a therapeutic treatment once this thorough assessment is complete and it has established that  the benefits greatly outweigh any potential risks.

What treatments have been provisionally registered?

Information about provisionall registered treatments is available on the COVID-19 treatment: provisional registrations webpage. The TGA’s assessment process and how the regulatory decision was made for each COVID-19 treatment is available by clicking on the treatment name in the table.

Can Ivermectin be used to prevent or treat COVID-19?

Ivermectin has not received regulatory approval in Australia or by other comparable countries for use as an anti-viral treatment. Although there are some studies published either on unreferenced websites or in lower-tier medical journals, the consensus view of major regulators and in top-tier international medical journals is that the evidence for the clinical efficacy and safety of ivermectin for the treatment or prevention of COVID-19 is not strong at this stage. More evidence is required before it could be considered a safe and effective treatment option.

A very recent analysis of all published ivermectin trials by the Cochrane Collaboration, the main independent group globally responsible for looking at evidence on the effectiveness of medicines or other medical therapies, also concluded that ivermectin could not be recommended for COVID-19 treatment or prevention. This report is titled ‘Ivermectin for preventing and treating COVID‐19’ and can be found on the Cochrane Library website.

In addition, the National COVID-19 Clinical Evidence Taskforce, consisting of a large group of independent Australian clinical experts, is continuously updating treatment recommendations based on the best available evidence. They are not recommending the use of ivermectin for COVID-19 treatment outside of clinical trials with appropriate ethical approval.

Can hydroxychloroquine be used to prevent or treat COVID-19?

Hydroxychloroquine has not received regulatory approval in Australia or other comparable countries for the treatment or prevention of COVID-19.

The TGA strongly discourages the use of hydroxychloroquine to treat COVID-19 (including in hospitalised patients) or prevent COVID-19, unless the patient is enrolled in a clinical trial, which will have safety monitoring protocols and oversight by a Human Research Ethics Committee.

The use of hydroxychloroquine for the treatment or prevention of COVID-19 is not recommended by the National COVID-19 Clinical Evidence Taskforce.

For further information about this recommendation, refer to: Amendments to the new restrictions on prescribing hydroxychloroquine for COVID-19