Regulation of therapeutic goods in Western Australia

If you are a person or business that imports, exports, manufactures or supplies goods intended for therapeutic use, you are likely to be affected by requirements of Australian therapeutic goods legislation.

Therapeutic goods

Therapeutic goods are broadly defined as products for human use in connection with:

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

Therapeutic goods also include ingredients or components used in the manufacture of therapeutic goods, and items used to replace or modify parts of the body.

Types of regulated therapeutic goods

• Medicines
  prescription medicines, over-the-counter medicines and complementary medicines
• Medical devices
  products that work in a physical or mechanical way on the human body, or are used to measure or monitor the body. This includes a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, X-ray equipment, and so on.
• Biological and blood products
  tissue-based products (skin, bone, ocular, cardiovascular, amnion), cell-based products, immunotherapy products containing human cells, products that comprise or contain live animal cells or tissues, autologous human cells and tissue products, faecal microbiota transplant, whole blood, blood components (red cells, white cells, platelets, plasma),  plasma derived products, recombinant products, haematopoietic progenitor cells, gene therapies, gene modified cell therapies.
• Other products
  disinfectants and sterilants, tampons and menstrual cups, e-cigarettes and vapes.

Regulation of therapeutic goods

Western Australia is part of a National cooperative scheme that regulates therapeutic goods consistently across Australia.

In Australia, therapeutic goods are regulated with regard to:

• import
• export
• manufacture
• supply
• advertising.

The objective of this regulation is to ensure that therapeutic goods in the marketplace for use by Australian community are safe, of high quality and of a standard at equal to that of comparable countries.

The Therapeutic Goods Administration (TGA) is the National body responsible for regulating therapeutic goods.

The TGA regulates therapeutic goods through:

• pre-market assessments
• post-market monitoring and enforcement of standards
• licensing of Australian manufacturers
• verifying overseas manufacturers comply with standards to equivalent Australia.

All therapeutic goods carry some potential risks, which can range from minor to serious. Scientific and clinical expertise is applied to consider whether benefits of a product outweigh the risks. Factors such as side effects, harm from prolonged use, toxicity, and the seriousness of the medical condition for which the product is intended are all considered when assessing risks.

The level of regulatory control exerted over different categories of products changes with the level of risk posed by the medicine or device.

Commonwealth legislation

The National legislation, regulations, standards and controls for therapeutic goods are laid out in Commonwealth laws, under the Therapeutic Goods Act 1989, and associated regulations and legislative instruments.

Western Australian legislation

Each state and territory of Australia has enacted corresponding legislation that adopts or applies the Commonwealth law as a law of that jurisdiction.

In Western Australia the relevant legislation is the Therapeutic Goods Law Application Act 2024, which was proclaimed on 30 August 2024.

This means that the Commonwealth laws on therapeutic goods apply to persons conducting business in Western Australia, whether operating as a corporate entity or as a sole trader.  

More information

Public Health Regulation Directorate
Address: PO Box 8172, Perth Business Centre, WA 6849
Phone: 9222 2277