TGA approval for sale

Read about a medicine's journey from the lab to the public, including approval by the Therapeutic Goods Administration and assessment for a subsidy under the Pharmaceutical Benefits Scheme (PBS).

How are medicines approved?

In Australia, all medicines must be approved for sale by the Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health. Manufacturers of prescription medicines will usually also apply for the medicine to be subsidised under the Pharmaceutical Benefits Scheme (PBS). If a medicine is subsidised under the PBS, the Government pays a portion of the cost.

These are two separate processes:

  1. TGA approval — If the TGA is satisfied that the medicine meets its standards for manufacturing quality, safety and effectiveness in treating a particular illness, it will approve it for sale in Australia.
  2. PBS listing — If the Pharmaceutical Benefits Advisory Committee (PBAC) decides the medicine works as well or better than other medicines for treating a particular illness, and the price is acceptable, it will recommend that it be subsidised on the PBS. In most cases, the Government will accept this recommendation. See PBS listing.

TGA approval

The TGA approval process involves reviewing the evidence to assess a medicine's safety and efficacy as well as checking that the medicine meets manufacturing quality standards. When a medicine is approved by the TGA, a decision about how freely it will be available is also made (e.g prescription or non-prescription). Find out why some medicines are more freely available than others.

Prescription medicines

For prescription medicines, evidence about their benefits and risks must come from approved clinical trials.

The TGA must approve the clinical trial evidence of the medicine's stated benefits and agree that all the recognised side effects are acceptable. The TGA also checks to see that the information about the benefits and side effects in the product information for those prescribing the drug is accurate and clear.

Typically, it takes a long time for a medicine to be developed and to accumulate enough evidence to be approved for sale — perhaps around a decade. Many medicines don't make it through this long process because they don't do well enough in the early trials.

A medicine's journey from the lab to the public

A medicine's journey

A medicine must pass a series of experiments, trials, and approval processes before it is available for sale.

Non-prescription medicines

The rules for TGA approval of non-prescription medicines vary according to safety of the ingredients. These medicines are categorised as lower or higher risk according to their side effects and the seriousness of the illnesses they treat.

  • Listed medicines — These are lower risk products and show an 'AUST L' number on the label. The TGA assesses their quality and safety, but not efficacy. This means the TGA has not evaluated these medicines individually to see if they work. This category includes products with well-known established ingredients, such as vitamin and minerals, and many complementary medicines that have a long history of traditional use. (Most complementary medicines are listed products, but some are registered.) Read more about how the TGA assesses listed medicines.

  • Registered medicines — These are higher risk products and show an 'AUST R' number on the label. The TGA does a comprehensive assessment of their quality, safety, and efficacy. This category of medicines includes mild pain relievers, cough and cold preparations, and antifungal creams.

Useful links

For more information