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Benefits versus risks approach to regulating therapeutic goods

All therapeutic goods have some level of risk. Our role is to ensure that, on balance, the benefits outweigh any known risks. Watch this video to find out:

  • how we weigh the potential benefits of a product against the risks
  • the different processes associated with lower risk and higher risk goods
  • what we do if a problem is identified after a product has been released to the market
  • how you can help us to monitor safety by reporting problems with therapeutic goods.


Benefits versus risks approach to regulating therapeutic goods

The benefits and risks of medicines and medical devices

Medicines and medical devices are used when you are sick, or to prevent illness.

To be effective, they must modify the way the body works. This means there are risks, as well as benefits, associated with their use.

Because of the risks, these products are regulated

The TGA assesses medicines and medical devices according to what type of product they are, and their associated level of risk.

Therapeutic goods cannot lawfully be supplied in Australia unless they have been authorised by the TGA, or are exempt.

The potential benefits of an individual product will determine what risks we are prepared to accept before authorising the product for supply.

A balancing act

The TGA's role is to ensure that, on balance, the benefits outweigh any known risks.

To do this, we have to know what the benefits and risks are.

How do we know about the benefits and risks of medicines?

Before a product is made available to the public, benefits can be determined through laboratory studies and clinical trials.

These scientific studies look at, for example:

  • Chemistry
  • Pharmacology
  • Toxicity
  • Physiology
  • Biochemistry
  • Anatomy
  • Epidemiology
  • Immunology
  • Genetics

Further information about clinical trials can be found at:

Some products are used by millions of people

When authorising a medicine we take into account the overall risk and benefit to the entire population.

There is huge diversity across the population, so it's not possible to consider the risk a medicine or medical device may pose to every individual patient.

What do we do for higher risk medicines?

We look at:

  • Extensive clinical trials in healthy and sick volunteers

We also look at:

  • Pharmacodynamics - how the medicine works in the body
  • Pharmacokinetics - how the body metabolises the medicine
  • Toxicity
What else do we do for higher risk medicines?

We also look at:

  • Pharmaceutical chemistry
  • Shelf life
  • Risk factors

What do we do for lower risk medicines?

We ensure they only contain:

  • permitted ingredients - those we already know are lower risk

The TGA requires companies to hold the necessary evidence to support the claims being made, including the therapeutic claims.

How do we know about the benefits and risks of medical devices?

We check there are no unacceptable risks for medical devices, including software design and engineering.

We look at all the information to determine if the benefits outweigh the risks.

What's the difference between higher and lower risk medical devices?

To make decisions about the level of risk we look at:

  • The intended use of the device
  • The risk to patients
  • The degree of invasiveness in the body
  • The duration of use

Medical devices can't be tested like medicines in traditional clinical trials. Most devices are improvements of older versions based on data collected from real life use.

For both higher risk and lower risk products we require that they are manufactured in accordance with internationally agreed standards.

No approved product is without risk

To be approved the benefits of a medicine or medical device must outweigh the known risks for the intended purpose.

Our work is ongoing

We regulate medicines and medical devices for as long as they are being used.

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

  • manufacturing
  • marketing
  • supply
  • hazards
  • adverse events

We're always on the lookout for potential problems

Once a product is authorised, it can be used in the general population.

This means it may be used in situations where the TGA has not assessed the risks and benefits.

These situations can lead to unknown problems that were not identified in the evaluation process.

This is why it is important that you report problems to us.

You can 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.

Adverse medicine events line: 1300 134 237

Problems with medical devices: 1800 809 361

What happens when you tell us about a problem?

We assess the new evidence and decide if any action needs to be taken.

This may include:

  • Issuing new safety advice and information
  • Monitoring the product over time to identify any further issues
  • Recalling the product
  • Restricting access

What happens if the rules are broken

  • If a sponsor breaks the conditions of the authorisation, the therapeutic good could be cancelled or suspended. 
  • It is important that suppliers know what is legal and illegal - we provide information and educational activities to assist them.

You can find out more:

1800 020 653

More information from the TGA

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


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.