Therapeutic Goods Administration
From Wikipedia, the free encyclopedia
The Therapeutic Goods Administration or TGA is the regulatory body for drugs and therapeutic goods in Australia. It is a unit 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.
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[edit] TGA units
The TGA consists of units including the:
- Adverse Drug Reactions Advisory Committee (ADRAC) and Adverse Drug Reactions Unit
- Australian Drug Evaluation Committee (ADEC)
- National Drugs and Poisons Scheduling Committee (NDPSC)
- Office of the Gene Technology Regulator (OGTR)
- Therapeutic Goods Committee (TGC) and Therapeutic Devices Evaluation Committee (TDEC)
[edit] 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.
[edit] See also
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Food and Drug Administration (FDA, USA)
- European Medicines Agency (EMEA, EU)
- Ministry of Health, Labour and Welfare (Japan)
