Therapeutic Goods Administration

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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.

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)

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)

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.

See also

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Standard for the Uniform Scheduling of Drugs and Poisons
• Australia New Zealand Therapeutic Products Authority

External links

• TGA website