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The role of the TGA

You have probably learned a bit about the TGA through your professional practice, but there are aspects of our work that you may not be aware of.

Watch this video to find out:

  • what we do and don't regulate
  • how we weigh the benefits of therapeutic goods against their risks for the population, just as you do for your individual patients
  • when we need you to report problems to us to help us monitor safety.

Transcript

Show transcript for this video

The role of the TGA - Information for health professionals

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.

What do we regulate?

Therapeutic goods are used for:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
  • influencing, inhibiting or modifying a physiological process
  • testing the susceptibility of people to a disease or ailment
  • influencing, controlling or preventing conception
  • testing for pregnancy

What do we regulate?

Therapeutic goods include:

  • prescription medicines, including vaccines
  • biologicals
  • blood and tissue products
  • over-the-counter medicines
  • complementary medicines
  • medical devices, including in vitro diagnostic devices

We also regulate the manufacturing and advertising of all these products.

For lecture materials on the different types of therapeutic goods see: www.tga.gov.au/educational-materials

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 

Did you know?

  • We review the manufacturing information for every batch of every vaccine
  • We test the first five batches of most biological medicines
  • We perform targeted investigations of medicines for suspected non-compliance
  • We seek advice from experts on our advisory committees
  • We test devices for sterility and when they have been involved in adverse events

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.

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 prescribing.

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

Before approving goods for supply we weigh the benefits and the risks involved with their use

Just as you consider the benefits and risks of the treatment you recommend
to an individual patient…

We assess the benefits and risks associated with particular goods for the population before authorising them for supply

Our work is ongoing

Our 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.

  • manufacturing
  • marketing
  • supply
  • hazards
  • adverse events

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 effectiveness or recommend one product over another
  • 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

We need you to report problems to us

You or your patient can report:

  • adverse events involving medicines (including vaccines) or medical devices
  • problems arising during manufacture, storage or handling
  • suspected counterfeit medicines or medical devices

www.tga.gov.au/reporting-problems

1800 044 114 - medicine adverse events

1800 809 361 - medical device problems

1800 020 653 - suspected counterfeit products

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 http://www.tga.gov.au/subscribe-updates

You can find out more:

www.tga.gov.au

1800 020 653

To report a problem with a medicine or medical device, go to:

www.tga.gov.au/reporting-problems

More information from the TGA

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

TGA basics

The TGA is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products.

What are 'therapeutic goods'?

Many of us use medicines or medical devices in our daily lives.

What the TGA regulates

The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods.

Australian Register of Therapeutic Goods

The ARTG contains therapeutic goods that can be lawfully supplied in Australia.

TGA structure

The TGA is a part of the Australian Government Department of Health.

The regulation of medical devices

Medical devices range from sticking plasters through to products such as pacemakers, artificial hips and contact lenses.

An overview of the regulation of complementary medicines in Australia

Also known as 'traditional' or 'alternative' medicines, these include vitamin, mineral, herbal and aromatherapy products.

Evaluation of a new medicine - The TGA's lifecycle approach to regulation

Before a prescription medicine can be marketed in Australia, the TGA assesses the risks and the benefits from the available evidence.

Laboratory testing program

Find out more about the TGA's laboratory testing program.

Useful links

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.