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Health sciences and medicine : Therapeutic Goods Administration - Essay Example

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Therapeutic Goods Administration (TGA), a division of the department of Health and Ageing of the Australian government is medicines, medical devices, vaccines, blood and blood, implants and a range of other products, including sunscreens and every other product for which therapeutic claims are required…
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Health sciences and medicine Essay: Therapeutic Goods Administration
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"Health sciences and medicine : Therapeutic Goods Administration"

Download file to see previous pages Every product in this category must be listed, registered or included in the Australian Register of therapeutic Goods (ATGA) before they are allowed in the Australian market. This means that TGA first have to evaluate therapeutic products before they enter the market, and keep them under regulatory control once they are in the market, assessing their performance and suitability for export from Australia. The TGA also regulates the manufacturing of therapeutic goods, making certain manufacturers abide by set quality standard. With a team of experts, the TGA inspects and examines manufacturing facilities around the world to ensure products supplied to Australia meet required standard. The TGA operates in alliance with consumers, health professionals, industry and its foreign counterparts to be effective in its function, especially to regulate products, which have become increasing complex as a result of fast rapid development in science and technology. The regulatory activities of the TGA are guided by the Therapeutic Goods Acts of 1989. ...
for all types of therapeutic products v) Group Support Unit (GSU) provides planning coordination and administration service to all areas of the Group. The Monitoring and Compliance Group (MCG) is the office responsible for regulating how medicines and devices are manufactured, and is divided into four offices and unit. The offices and unit include: i) Office of Product Review (OPR) is responsible for ensuring that the quality, safety, and performance of all therapeutic goods remain at the proper level after entering the Australian marketplace, and also, for the administration of legislative request for advertizing of therapeutic goods in Australia, coordinating recalls where necessary. ii) Office of Labouratory and Scientific Service (OLSS) is in charge of testing, quality assessment, and test procedure development. iii) Office of Manufacturing Quality (OMQ) is in charge of making certain that manufacturers of medicines and medical devices meet set quality standard. iv) Group Support Unit (GSU) provides planning, coordination and administrative service to the group. Regulatory Support Group provides regulatory support service TGA needs to function well and is divided into five offices and units. Pharmaceutical Benefit Scheme Pharmaceutical Benefit Scheme (PBS) is a part of the wider National Medicine policy of the Australian government, and is the instrument through which the government subsidizes the cost of necessary medicines. While many of these medicines need to be dispensed at a pharmacy and administered at home, others require medical direction, making them accessible only at hospitals. Most of the subsidized medicines available to patients are displayed on the PBS schedule list, accessible on-line. PBS is administered by Medicare Australia and so is available ...Download file to see next pagesRead More
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