COVID-19 treatment information for consumers and health professionals

Potential COVID-19 treatments fall into broad categories:

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

Working with international regulators

Through the pandemic we proactively engaged with local and overseas pharmaceutical companies.

Clinically promising COVID-19 treatments were fast-tracked through provisional registration in Australia. 

As a result, treatments were rigorously evaluated for safety, quality, and efficacy.

We worked closely with international regulators to: 

• harmonise regulatory approaches,
• share information and
• where it speeds up evaluation, collaboratively review new treatments.

How we approve a treatment

We are responsible for assessing all COVID-19 treatments before being used in Australia. 

There are several stages in the regulatory process, including:

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

Applications for COVID-19 treatments are submitted through:

• standard registration process
• provisional approval process 

How we evaluate a treatment

Australia rigorously assesses therapeutic treatments for safety, quality, and efficacy before approving them.

A large team of clinical and scientific experts at the TGA undertake a 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.

Whenever we approve a therapeutic treatment, it's because the benefits outweigh any risks.

Provisionally registered

Information about provisional registered treatments is available. 

The assessment process and regulatory decision for each COVID-19 treatment are available by clicking on the name.

Ivermectin

The National COVID-19 Clinical Evidence Taskforce are not recommending the use of ivermectin for COVID-19 treatment.

Hydroxychloroquine 

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