Therapeutic Goods Administration

Therapeutic Goods Administration

The Therapeutic Goods Administration or 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 Australian Department of Health and Ageing established under the "Therapeutic Goods Act 1989 (Cth)". The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.

TGA Branches

The TGA is divided into a number of Branches, including:
*Drug Safety and Evaluation Branch (DSEB), responsible for regulating prescription medicines
*Non-prescription Medicines Branch (NPMB), responsible for regulating over-the-counter and complementary medicines
*Office of Devices, Blood and Tissues (ODBT)
*Office of the Gene Technology Regulator (OGTR)

TGA Expert Advisory Committees

The TGA is supported in its work by a number of external expert advisory committees, including:
* Australian Drug Evaluation Committee (ADEC) - for prescription medicines
* Adverse Drug Reactions Advisory Committee (ADRAC)
* Medicines Evaluation Committee (MEC) - for over-the-counter medicines
* Complementary Medicines Evaluation Committee (CMEC) - for complementary medicines
* Therapeutic Devices Evaluation Committee (TDEC) - for medical devices
* National Drugs and Poisons Scheduling Committee (NDPSC)
* Therapeutic Goods Committee (TGC)

Trans-Tasman harmonisation

The governments of Australia and New Zealand were working towards establishing a Trans-Tasman joint agency for the regulation of drugs and therapeutic goods to replace the TGA and New Zealand's Medsafe. However, on 16 July 2007, the New Zealand State Services Minister Annette King announced that "The Government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products." She further advised that "The [New Zealand] Government does not have the numbers in Parliament to put in place a sensible, acceptable compromise that would satisfy all parties at this time. The Australian Government has been informed of the situation and agrees that suspending negotiations on the joint authority is a sensible course of action." Further details are available at the Australia New Zealand Therapeutic Products Authority (ANZTPA) website.

See also

* Australian Competition and Consumer Commission
* Australia New Zealand Therapeutic Products Authority
* International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
* List of Australian Commonwealth Government entities
* Standard for the Uniform Scheduling of Drugs and Poisons

External links

* [ TGA website]

Wikimedia Foundation. 2010.

Look at other dictionaries:

  • Therapeutic Goods Administration — noun the Australian federal government agency responsible for regulating medical drugs, medical devices, and organic substances used in medical treatment, as blood, blood components, and tissue and cellular products. Abbrev.: TGA …   Australian English dictionary

  • Therapeutics Goods Administration — The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an… …   Wikipedia

  • Regulation of therapeutic goods — The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are… …   Wikipedia

  • Australia New Zealand Therapeutic Products Authority — The Australia New Zealand Therapeutic Products Authority (ANZTPA) is a proposed authority which if adopted in both Australia and New Zealand will be the sole authority which regulates therapeutic goods in both countries. The authority will… …   Wikipedia

  • Food and Drug Administration — FDA redirects here. For other uses, see FDA (disambiguation). Food and Drug Administration Agency overview Formed 1906 …   Wikipedia

  • Drug Enforcement Administration — DEA redirects here. For other uses, see DEA (disambiguation). Drug Enforcement Administration Abbreviation DEA …   Wikipedia

  • U.S. Food and Drug Administration — Infobox Government agency agency name = Food and Drug Administration parent agency = logo width = 200px logo caption = FDA Logo formed = 1906 [cite web|url=|title=FDA Centennial 1906 2006|accessdate=2008 09… …   Wikipedia

  • Federal administration of Switzerland — Switzerland This article is part of the series: Politics and government of Switzerland …   Wikipedia

  • Patient safety organization — A patient safety organization (PSO) is a group, institution or association that improves medical care by reducing medical errors. In the 1990s, reports in several countries revealed a staggering number of patient injuries and deaths each year due …   Wikipedia

  • Alternative medicine — Alternative medical systems …   Wikipedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”

We are using cookies for the best presentation of our site. Continuing to use this site, you agree with this.