Therapeutic Goods Administration
Encyclopedia
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 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.
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.
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
. It is a Division of the Australian Department of Health and Ageing
Department of Health and Ageing (Australia)
The Department of Health and Ageing is an Australian Government department. Its role is to oversee the running of Australia including supporting universal and affordable access to medical, pharmaceutical and hospital services, while helping people to stay healthy through health promotion and...
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 Expert Advisory Committees
The TGA is supported in its work by a number of external expert advisory committees, including:- Australian Drug Evaluation CommitteeAustralian Drug Evaluation CommitteeThe Australian Drug Evaluation Committee or ADEC, was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs. The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 as part of the...
(ADEC) - for prescription medicines - Adverse Drug Reactions Advisory CommitteeAdverse Drug Reactions Advisory CommitteeThe Adverse Drug Reactions Advisory Committee or ADRAC is a subcommittee of the Australian Drug Evaluation Committee which monitors the safety of medicines in Australia...
(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 ZealandNew Zealand
New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...
were working towards establishing a Trans-Tasman
Trans-Tasman
Trans-Tasman is an adjective used primarily in Australia and New Zealand, which signifies an interrelationship between both countries. Its name originates from the Tasman Sea which lies between the two countries...
joint agency for the regulation of drugs and therapeutic goods to replace the TGA and New Zealand's Medsafe
Medsafe
Medsafe is the medical regulatory body run by the New Zealand Ministry of Health, administering the Medicines Act 1981 and Medicines Regulations 1984. Medsafe employs approximately 60 staff members in two offices...
. 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
Australia New Zealand Therapeutic Products Authority
The Australia New Zealand Therapeutic Products Authority is a proposed authority which if adopted in both Australia and New Zealand will be the sole authority which regulates therapeutic goods in both countries...
(ANZTPA) website.
See also
- Australian Competition and Consumer CommissionAustralian Competition and Consumer CommissionThe Australian Competition and Consumer Commission is an independent authority of the Australia government. It was established in 1995 with the amalgamation of the Australian Trade Practices Commission and the Prices Surveillance Authority to administer the Trade Practices Act 1974...
- Australia New Zealand Therapeutic Products AuthorityAustralia New Zealand Therapeutic Products AuthorityThe Australia New Zealand Therapeutic Products Authority is a proposed authority which if adopted in both Australia and New Zealand will be the sole authority which regulates therapeutic goods in both countries...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- List of Australian Commonwealth Government entities
- Standard for the Uniform Scheduling of Drugs and PoisonsStandard for the Uniform Scheduling of Drugs and PoisonsThe Standard for the Uniform Scheduling of Medicines and Poisons, abbreviated SUSMP, is a document used in the regulation of drugs and poisons in Australia. It is produced by the National Drugs and Poisons Scheduling Committee , a committee of the Therapeutic Goods Administration...
- Therapeutic Goods Act 1989