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Encyclopedia > 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. The Department of Health and Ageing is an Australian Government department. ...

Contents

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)

The Office of the Gene Technology Regulator, supports the Gene Technology Regulator, and is a part of the part of the Therapeutic Goods Administration within the Australian Government Department of Health and Ageing. ...

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)

The Australian Drug Evaluation Committee or ADEC, is a committee that provides independent scientific advice to the Australian Government regarding therapeutic drugs. ... The Adverse Drug Reactions Advisory Committee or ADRAC is a subcommittee of the Australian Drug Evaluation Committee (ADEC) which monitors the safety of medicines in Australia. ...

Trans-Tasman harmonisation

The governments of Australia and New Zealand are currently 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. Trans-Tasman is an adjective used primarily in Australia and New Zealand, which signifies an interrelationship between both countries. ...


See also

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... The Standard for the Uniform Scheduling of Drugs and Poisons, abbreviated SUSDP, is a document used in the regulation of drugs and poisons in Australia. ... 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. ...

External links

  • TGA website

  Results from FactBites:
 
Medicines Evaluation Committee (MEC) (530 words)
The MEC became a Statutory Committee as a result of amendments to the Therapeutic Goods Regulations commencing 31 March 2000.
Therapeutic goods being considered for inclusion in Part 3 of Schedule 10 to the Therapeutic Goods Regulations
Therapeutic goods specified by the Minister or the Secretary
  More results at FactBites »

 
 

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