Water-Jel Burn Treatment Receives TGA Listing

ARTG Number : 93458
ARTG Product Number and Name : 164091 Dressing, hydrogel

ARTG Number : 93343
ARTG Product Number and Name: 163975 Dressing, burn

Regulation of Therapeutic Goods in Australia

Overview

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 and ensure their quality, safety and efficacy.

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, any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before the product 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.

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.

For the purposes of evaluation and assessment, a therapeutic good is a product for use in humans that is used 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.

The role of the Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is a Division of the Federal Department of Health and Ageing and is responsible for administering the provisions of the Therapeutic Goods Act.

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.

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

  • pre-market assessment
  • licensing of manufacturers
  • post-market vigilance

Pre-market assessment

Products assessed as having a higher level of risk (prescription medicines, some non-prescription medicines and medical devices) are evaluated for quality, safety and efficacy. Once approved for marketing in Australia these products are included in the ARTG as 'registered' products and are identified by an AUST R number.

Products assessed as being lower risk (many non-prescription medicines including most complementary medicines and low risk medical devices) are assessed for quality and safety. Once approved for marketing in Australia, these products are included in the ARTG as 'listed' products and are identified by an AUST L number.

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.

Further information can be obtained from:

The Information Office
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Telephone: 1800 020 653
Fax: 02 6232 8605
TTY: 1800 500 236
Email: tga-information-officer@health.gov.au