How the TGA regulates

Overview

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The TGA regulates therapeutic goods through:

• pre-market assessment;
• post-market monitoring and enforcement of standards; and
• licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.

Therapeutic goods are divided broadly into two classes: medicines and medical devices. Medicines must be entered as either 'registered' or 'listed' medicines and medical devices must be 'included' on the Australian Register of Therapeutic Goods (ARTG) before they may be supplied in or exported from Australia, unless exempted.

If a problem is discovered with a medicine, device or manufacturer, the TGA is able to take action. Possible regulatory actions vary from continued monitoring to withdrawing the product from the market.

Risk management

The TGA approves and regulates products based on an assessment of risks against benefits.

All therapeutic goods carry potential risks, some of which are minor, some potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk.

In assessing the level of risk, factors such as side effects, potential harm through prolonged use, toxicity and the seriousness of the medical condition for which the product is intended to be used, are all taken into account. 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 proven benefits of reducing the risk of a heart attack or stroke.

The level of TGA regulatory control increases with the level of risk the medicine or device can pose. Risk information is used by the TGA when deciding how to approve a medication for supply. For example, a low-risk product may be safely sold through supermarkets, while higher-risk products may only be supplied with a prescription.

The TGA's approach to risk management involves:

• identifying, assessing and evaluating the risks posed by therapeutic products
• applying any measures necessary for treating the risks posed; and
• monitoring and reviewing risks over time.

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 their health needs.