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Therapeutic Goods Administration

TGA

1989 – present

Australia's regulator of therapeutic goods, part of the Commonwealth health department, which assesses, registers and monitors medicines, vaccines, medical devices and biologicals.

How it came into existence

Formed in 1989 within the Department of Community Services and Health by combining the National Biological Standards Laboratory with the department's therapeutic goods regulatory branches, to administer the national scheme created by the Therapeutic Goods Act 1989.

Legislation: Therapeutic Goods Act 1989

Changes during its life

  1. 15 February 1991The Therapeutic Goods Act 1989 came into force, replacing state-based controls with a national system of registration and listing on the Australian Register of Therapeutic Goods.

Main functions

  • Evaluation and registration of medicines and vaccines
  • Regulation of medical devices
  • Maintenance of the Australian Register of Therapeutic Goods
  • Post-market monitoring and safety alerts
  • Laboratory testing of therapeutic goods
  • Licensing of manufacturers

Where it sits

Lineage

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Sources

Primary sources

Government records and websites

Some dates or links for this organisation are not fully confirmed. Corrections are welcome.