Market Regulation - Therapeutic Goods Administration
Market regulation aims to ensure that new therapeutic goods are safe, perform as intended and are produced using appropriate standards before market approval for use in Australia is granted. Market regulation also ensures that goods that are found to be unsafe are removed from the market. This function is established under the Therapeutic Goods Act 1989 and is currently the responsibility of the Therapeutic Goods Administration (TGA), which is part of the Australian Government’s health portfolio. Approved therapeutic goods are entered on the Australian Register of Therapeutic Goods (ARTG). Where a therapeutic good is considered for reimbursement, the TGA approval process must be completed before the reimbursement decision is finalised.
Therapeutic Goods Act 1989
Therapeutic Goods Administration
Australian Register of Therapeutic Goods (ARTG)
Advisory Committee on Medical Devices (ACMD)
Advisory Committee on Prescription Medicines (ACPM)
Therapeutic Goods Act 1989The Therapeutic Goods Act 1989 came into effect in February 1991 and provides 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.
Therapeutic Goods AdministrationThe Therapeutic Goods Administration (TGA) is Australia’s independent national regulator of therapeutic goods and is responsible for ensuring that only safe and effective health technologies are marketed for supply in Australia. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. The TGA also aims to ensure that the Australian community has timely access to therapeutic advances.
The TGA regulates therapeutic goods through:
- pre-market assessment;
- post-market monitoring and enforcement of compliance with standards; and
- licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts.
- identifying, assessing and evaluating the risks posed by therapeutic goods;
- applying any measures necessary for treating the risks posed; and
- monitoring and reviewing risks over time.
Australian Register of Therapeutic GoodsThe Australian Register of Therapeutic Goods (ARTG) was established under the Therapeutic Goods Act 1989. The Act requires that medical products to be imported into, supplied in, or exported from Australia be entered on the ARTG. For a product to be entered on the ARTG, a sponsoring company must make an application which usually consists of a form accompanied by data to support the quality, safety and efficacy of the product for its intended use.
The Therapeutic Goods Act 1989, Regulations and Orders set out the requirements for inclusion of therapeutic goods on the ARTG, including advertising, labelling, product appearance and appeal guidelines. The ARTG is updated in real time.
Listing, registration or inclusion on the ARTG is generally a requirement for any health technology to enable it to be listed for reimbursement under an Australian Government funding program.
Advisory Committee on Medical Devices (ACMD)The Advisory Committee on Medical Devices (ACMD) provides independent medical and scientific advice to the Minister and the TGA on the safety, quality and performance of medical devices supplied in Australia including issues relating to pre-market conformity assessment and post-market monitoring.
The Committee is established under Regulation 38 of the Therapeutic Goods Regulations 1990 and the members are appointed by the Minister for Health and Ageing.
On 1 January 2010, changes were made to the Therapeutic Goods Regulations 1990, which established the ACMD in place of the previous Committee, the Medical Devices Evaluation Committee.
Further information on ACMD
Further information about ACMD outcomes
Advisory Committee on Prescription Medicines (ACPM)The Advisory Committee on Prescription Medicines (ACPM) was formed in January 2010. The ACPM advises and makes recommendations to the TGA on prescription medicines. This includes:
- inclusion of a prescription medicine on the ARTG;
- changes to an entry of a prescription medicine on the ARTG; and
- removal or retention of a prescription medicine on the ARTG
The ACPM is the successor of the Australian Drug Evaluation Committee (ADEC), which was formed in 1963.
Further information on ACPM
The TGA prepares and publishes Australian Public Assessment Reports (AusPAR) for prescription medicines assessed by the TGA. The AusPAR provides information about the evaluation of a prescription medicine and the consideration that led the TGA to approve or not approve an application.
Further information about AusPARs
Advisory Committee on BiologicalsThe Advisory Committee on Biologicals (ACB) will advise and make recommendations to the Health Minister or the Secretary of the Department of Health and Ageing on:
- which biologicals can be included on the ARTG
- variations to entries on the ARTG
- removal or continued inclusion of biologicals on the ARTG
- any other matters concerning a biological, or other matters referred to the ACB by the Minister or Secretary.
The ACB can provide advice on issues other than biologicals, if necessary, and all recommendations must be published.
This committee will be established in 2012.
Further informationFurther information about the TGA or how to make an application for listing, registration or inclusion on the ARTG is available from
|Phone||1800 020 653 (free call within Australia)
|Post||Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
|Street address||136 Narrabundah Lane, Symonston ACT 2609, Australia|
Page currency, Latest update: 04 November, 2011