Therapeutic Goods Administration

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The Therapeutic Goods Administration (TGA) [1] is part of the Australian Government Department of Health and is responsible for regulating therapeutic goods in Australia, including medicines, medical devices and biologicals (cell and tissue therapy products).

The TGA administers the Therapeutic Goods Act 1989 (Cth)[2][3] and applies a risk management approach [4] designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.

Therapeutic goods are evaluated before they are released to the market and monitored after they are available on the market. The TGA also assesses the suitability of medicines and medical devices for export from Australia, and regulates manufacturers to ensure they meet acceptable standards of manufacturing quality.

The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.

Reporting problems[edit]

The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices[5]. The TGA investigates reports received to determine any necessary regulatory action.

Australian consumers and health professionals are encouraged to report:

  • adverse events to medicines and vaccines
  • problems with a medical devices
  • medicine deficiencies or defects
  • suspected counterfeit medicines or medical devices.

These reports can be made online at the TGA website [6].

The TGA cannot give advice about an individual's medical condition. Anyone concerned about a possible adverse event associated with a medicine, vaccine or medical device is encouraged to speak with a health professional.

TGA Expert Advisory Committees[edit]

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[edit]

The Australian and New Zealand governments are working together to implement a joint scheme for the regulation of therapeutic products in both countries. As a result of this, a new agency—the Australia New Zealand Therapeutic Products Agency (ANZTPA)—will replace the TGA and the New Zealand Medicines and Medical Devices Safety Authority,Medsafe.

The Australian and New Zealand Governments originally agreed to the joint scheme in 2003. Although the initial stages of work were ceased in 2007, this commitment was reaffirmed in 2011 and a new phase of work commenced. Development of the joint regulatory scheme is underway with implementation occurring in stages over the five years to 2016.

Australia and New Zealand have already begun to share resources, expertise and information; building the regulatory capacity in both countries.

Further information is available on the ANZTPA website.

References[edit]

  1. ^ "About the TGA". Therapeutic Goods Administration. 
  2. ^ "About the Australina therapeutic goods legislation". Department of Health Therapeutic Goods Administration. 
  3. ^ Therapeutic Goods Act 1999 (Cth)
  4. ^ "Product regulation according to risk". Therapeutic Goods Administration. Retrieved 16 April 2014. 
  5. ^ "Reporting problems". Therapeutic Goods Administration. Retrieved 16 April 2014. 
  6. ^ "Reporting problems". Therapeutic Goods Administration. Retrieved 16 April 2014. 

External links[edit]

Further reading[edit]