The role of the TGA

Information for consumers

Making sure you have access to therapeutic goods that are good quality - meaning that they have been properly formulated and manufactured to certain standards - is an important and complex job. Watch this video to find out:

  • who we are and where the regulatory system originated
  • how the regulatory system operates
  • what products we regulate, and the different processes applied to lower and higher risk products
  • how you can help us to improve public health and safety.

Transcript

Information for consumers

What is the TGA?

We regulate therapeutic goods in Australia, including how they are manufactured and advertised.

We are part of the Australian Government Department of Health.

We regulate:

  • imports
  • supply
  • exports
  • manufacturing
  • advertising.

What are therapeutic goods?

The term therapeutic goods includes products such as medicines and medical devices.

What are medicines?

A wide variety of products are classed as medicines, including prescription and over-the-counter medicines, vaccines, complementary medicines, and blood and plasma products.

What are medical devices?

Medical devices include a wide variety of products, ranging from lower risk items like adhesive bandages through to higher risk devices like pacemakers.

Where did the TGA come from?

In 1961, the medicine thalidomide was found to have devastating unforeseen effects on unborn babies.

Governments realised they had an important role to play in assessing therapeutic goods to determine if the balance of benefits to risks is acceptable.

We employ highly qualified people...

who make sure Australia's therapeutic goods meet quality and safety requirements.

These include doctors, scientists and biomedical engineers, as well as many other specialists. We also consult with experts from our advisory committees when required. Find out more about us on our website.

How complex is our work?

Assessing and balancing benefits and risks of therapeutic goods is incredibly complex.

For example, highly qualified TGA staff must read, analyse, question and evaluate thousands of pages of documentation to assess the quality, safety and efficacy of new, higher risk prescription medicines.

Why is regulation important?

All therapeutic goods carry some level of risk. We try to make sure that the benefits to the population outweigh the risks.

What kinds of benefits and risks do we consider?

For higher risk products, we weigh up whether the product will improve the quality of life and health of the population against factors such as adverse effects and toxicity.

Look at the benefits versus risk approach information on our website.

How do we regulate?

We have systems in place to:

  • ensure manufacturers meet standards for producing goods
  • authorise supply
  • monitor products once they are on the market and take action if there are problems
  • identify illegal activities like counterfeiting and take action to stop these occurring.

We regulate throughout the lifecycle of every product

The TGA's work doesn't stop when a product reaches the market. It continues over the lifecycle of every therapeutic good.

We regulate therapeutic goods throughout their lifecycle in a number of ways:

  • assess evidence
  • authorise
  • monitor
  • recalls, safety alerts, changes to product information
  • enforce compliance.

We don't need to test every product

We can't test everything. There are too many medicines and medical devices available or in development.

We usually test for a particular reason, such as for medicines that are harder to manufacture consistently, or that are suspected to be counterfeit or to contain extra, unnamed ingredients.

We also have stringent systems in place to make sure products are manufactured to the highest quality.

How can I tell if a medicine is regulated by the TGA?

Lower risk medicines, such as vitamins or herbal supplements, have an AUST L number on the label.

Higher risk medicines, such as prescription medicines or painkillers, have an AUST R number on the label. These medicines are tested for efficacy.

You can look on the package to see the AUST L and AUST R numbers issued by us.

Look for the AUST L or AUST R number on the package or on our website

Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia, unless there is an exemption.

Search the AUST L, AUST R or product name on the ARTG on our website to find out more about the products you're using.

Australian Register of Therapeutic Goods - www.tga.gov.au.

We only regulate therapeutic goods

Other government agencies regulate:

  • Veterinary medicines
    • Australian Pesticides and Veterinary Medicines Authority
  • Health professionals
    • Australian Health Practitioner Regulation Agency
  • Health insurance
    • Private Health Insurance Administration Council
  • Food regulation
    • States and Territories and Food Standards Australia New Zealand
  • Cosmetic and chemical standards
    • National Industrial Chemicals Notification and Assessment Scheme

We don't:

  • Research and develop new therapeutic goods
  • Provide clinical advice to individuals
  • Consider cost or compare one product with another when making our decisions
  • Make decisions about subsidy of therapeutic goods. The PBS and other areas of government have this responsibility.

Visit the Department of Health's website to find out more: www.health.gov.au.

You can help improve public health and safety

  • If you experience an unexpected side effect from a therapeutic good, first seek advice from a health professional.
  • Then contact us to tell us what happened. You can also ask your health professional to do this for you.
  • These reports help us monitor therapeutic goods and we use this information as one of the triggers for taking action.

www.tga.gov.au/reporting-problems

Adverse medicine events line: 1300 134 237

Problems with medical devices: 1800 809 361

How can you stay up-to-date with TGA information?

We provide email subscription services to notify subscribers when new information is published on our website.

  • Alerts
  • Recalls
  • Safety information

To subscribe to TGA email lists, go to www.tga.gov.au/subscribe-updates.

You can find out more

www.tga.gov.au

1800 020 653

More information from the TGA

Explore the TGA website and find information related to this presentation with the links below.

Disclaimer

These educational materials are provided by the TGA (a part of the Department of Health) solely for the purpose of providing general education on the TGA regulatory scheme. The materials should not be taken to be a detailed description of the scheme, or advice on the application of the therapeutic goods legislation in particular cases. Nor should they be taken to be statements of policy.

People requiring information or advice on the application of the therapeutic goods legislation in particular cases should make their own enquiries.

Whilst due care has been taken in their preparation, the Department of Health cannot guarantee, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information contained in these materials. These materials are based on the scheme as it is in February 2014.