About the work of the TGA - a risk management approach

15 August 2011

Whether applying a bandage, relieving a headache with items from the supermarket or undertaking a prescribed course of treatment to manage a serious illness, Australians can expect the medicines and medical devices they use to meet an acceptable level of safety and quality.

No therapeutic good is risk free. The work of the TGA is based on applying scientific and clinical expertise to decision making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines, medical devices and other therapeutic goods. For example, some blood pressure medications may include side effects, such as a tickle in the throat or persistent cough, but this risk is outweighed by the benefits of reducing the risk of a heart attack or stroke. The risk - benefit approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to health needs.

Risk information is used by the TGA when deciding whether to approve a medication for supply and the conditions that might be imposed on that approval. The level of TGA regulatory control increases with the level of risk the medicine or device can pose and determines how consumers can access these goods. For example a low-risk product may be safely sold through the supermarket, while higher-risk products may only be supplied with a prescription.

A product's 'risk' is determined by a number of factors, including whether:

  • the product contains a substance scheduled in the Poisons Standard
  • the product's use can result in significant adverse effects
  • the product is used to treat life-threatening or very serious illnesses
  • there may be any adverse effects from prolonged use or inappropriate self-medication

Risk is not an absolute concept. It is an assessment of the potential of a product to do harm to those it is intended to help, or to others (such as children) who may come in contact with it regardless of whether the harm results from following or disregarding the directions for use.