Therapeutic Goods Administration
Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. It is a division of the Department of Health and is responsible for regulating therapeutic goods to ensure they meet acceptable standards of safety, quality, and efficacy.
Pronunciation
Therapeutic Goods Administration: /θɛrəˈpjuːtɪk ɡʊdz ˌædmɪnɪˈstreɪʃən/
Etymology
The term "Therapeutic Goods Administration" is derived from its function. "Therapeutic" refers to the healing of disease, "Goods" refers to the products it regulates, and "Administration" refers to the act of managing or supervising.
Related Terms
- Therapeutic Goods Act 1989
- Australian Register of Therapeutic Goods
- Pharmaceutical Benefits Scheme
- National Health and Medical Research Council
Functions
The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
History
The TGA was established in 1991 following the enactment of the Therapeutic Goods Act 1989. The Act provides for the establishment of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia, or exported from Australia.
See Also
- Food and Drug Administration
- European Medicines Agency
- Medicines and Healthcare products Regulatory Agency
This WikiMD.org article is a stub. You can help make it a full article.