Harman Patil (Editor)

Therapeutic Goods Administration

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Formed
  
1989

Parent department
  
Department of Health

Founded
  
1989

Annual budget
  
A$139 million (2015)

Website
  
www.tga.gov.au

Therapeutic Goods Administration httpswwwtgagovausitesallthemestgatheme

Jurisdiction
  
Commonwealth of Australia

Profiles

Snapshot 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 Australian Department of Health 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.

Contents

Ross noble nonsensory overload therapeutic goods administration


TGA Expert Advisory Committees

The TGA has nine statutory expert committees it may call upon to obtain independent advice on scientific and technical matters, including:

  • Advisory Committee on Biologicals (ACB)
  • Advisory Committee on Complementary Medicines (ACCM)
  • Advisory Committee on Medical Devices (ACMD)
  • Advisory Committee on Non-prescription Medicines (ACNM)
  • Advisory Committee on Prescription Medicines (ACPM)
  • Advisory Committee on the Safety of Medical Devices (ACSMD)
  • Advisory Committee on the Safety of Medicines (ACSOM)
  • Advisory Committee on the Safety of Vaccines (ACSOV)
  • Therapeutic Goods Committee (TGC) – advises the Minister on standards for therapeutic goods, including labelling and packaging, and on principles to be observed in the manufacture of therapeutic goods for use in humans.
  • 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.

    References

    Therapeutic Goods Administration Wikipedia