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Regulation of therapeutic goods in Australia

April 2005

Overview

The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries. The objective of the Therapeutic Goods Act 1989, which came into effect on 15 February 1991, is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices.

The regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

Essentially therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) <http://www.tga.gov.au/docs/html/artg.htm> before they can be supplied in Australia. The ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or exported from, Australia.

The Therapeutic Goods Act 1989, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the ARTG, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation.

The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing and is responsible for administering the provisions of the legislation.

The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. At the same time the TGA aims to ensure that the Australian community has access, within a reasonable time, to therapeutic advances.

What is a therapeutic good?

A 'therapeutic good' is broadly defined as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use (unless specifically excluded or included under Section 7 of the Therapeutic Goods Act 1989).

Therapeutic use means use in or 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; or
  • replacement or modification of parts of the anatomy.

Overall control of the supply of therapeutic goods is exercised through three main processes:

  • Auditing and assessment of the quality of their manufacture.
  • Pre-market assessment of the goods
  • Post market monitoring of compliance with standards once the goods are supplied on the market.

Regulating medicines

Australian manufacturers of all medicines must be licensed under Part 4 of the Therapeutic Goods Act 1989 and their manufacturing processes must comply with the principles of GMP (Good Manufacturing Practice).

Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines having a lower risk (consumer medicines purchased over the counter such as complementary medicines including vitamins) are assessed for quality and safety. In assessing the level of risk, factors such as the strength of a product, 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.

Once approved for marketing in Australia, medicines are included in the ARTG and can be identified by the AUST R number (for registered medicines) or an AUST L number (listed medicines) that appears on the packaging of the medicine.

Also see:

Regulating medical devices

The regulation of medical devices includes the following features:

  • classifying the medical device based on different levels of risk;
  • assessing compliance with a set of essential principles for their quality, safety and performance;
  • implementing appropriate regulatory controls for the manufacturing processes of medical devices;
  • including the medical device in the ARTG; and
  • implementing a comprehensive post market vigilance and adverse incident reporting program.

Also see: Overview of the medical device regulatory process <http://www.tga.gov.au/devices/process.htm>

Post marketing vigilance

Post marketing activities include investigating reports of problems, laboratory testing of products on the market and monitoring to ensure compliance with the legislation.

Further information can be obtained from:

  • Mail: TGA Communications Section, PO Box 100, Woden ACT 2606, Australia
  • Phone:
    • 1800 020 653 (freecall within Australia)
    • 02 6232 8610 (for publications enquiries)
    • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
      • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
      • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
  • Fax: 02 6232 8605
  • Email:

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