Australias Therapeutics Goods Administration

The number of staff working in these laboratories varies greatly, ranging from as few as four full-time posts (actually two full-time and four part-time staff) in the mini-lab in Uganda, to as many as 131.5 full-time posts (actually 129 full-time and five part-time staff) working for the Therapeutic Goods Administration Laboratory (TGAL) in Australia. 

TGAL Therapeutic Goods Administration Laboratory (Australia)... 

Australia s Therapeutic Goods Administration (TGA) has perhaps one of the most progressive and comprehensive regulatory systems in the world. Under the Therapeutic Goods Act, the TGA regulates prescription medicines, OTC... 

Australia s Therapeutic Goods Administration website, http //www.tga.gov.au/ [accessed July 29,2007]. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

Therapeutic Goods Administration Laboratories of Australia (TGAL) (1990), Guidelines for Assessing the Results of Microbiological Tests on Nonsterile Pharmaceuticals for Human Use, TGAL, Canberra, Australia. 

The importation and manufacture of new chemicals in Australia is regulated under Industrial Chemicals (Notification and Assessment) Act 1989 [1] which is administered by National Industrial Notification and Assessment Scheme (NICNAS) [2 ]. NICNAS was operated within the National Occupational Health and Safety Commission until November 2001, when it was transferred to the Therapeutic Goods Administration (TGA). 

Khat has been recognized as a substance of abuse with increasing popularity. It is estimated that 10 million people chew khat worldwide, and it is used by up to 80% of adults in Somalia and Yemen. It now extends to immigrant African communities in the UK and USA. It is banned in Saudi Arabia, Egypt, Morocco, Sudan, and Kuwait. It is also banned in the USA and European countries. However, in Australia, its importation is controlled by a licence issued by the Therapeutic Goods Administration, which allows up to 5 kg of khat per month per individual for personal use. 

TGA (1990), Australian Code of Good Manufacturing for Therapeutic Goods, Medicinal Products — Part 1, Therapeutic Goods Administration, Wooden, Australia. 

Australia s Therapeutic Goods Administration initiated a voluntary recall of all complementary medicines containing kava after the death of a woman who used a medicine containing kava (13). Sponsors and retailers were asked to remove all products containing kava from the market immediately. Consumers were advised to discard kava-containing products in their possession. 

Discussions on Trans-Tasman Mutual Recognition are continuing between Medsafe and the Therapeutic Goods Administration (TGA) of the Commonwealth Department of Human Services and Hesilth in Australia. A formal consultation process will extend to industry groups, consumers and other interested parties in due course. 

General Clinical trials of products approved for registration are not covered by the above categories and are considered to be subject to the Therapeutic Goods Administration s Guidelines for Good Clinical Research Practice (GCRP) in Australia.55... 

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Annotated with TGA comments. Therapeutic Goods Administration [TGA] (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted CPMP/ICH/ 135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of local regulatory requirements , July 2000. http //www.health.gov.au/tga/docs/html/ ichl3595.htm. 

In Australia, the most commonly utilized and accessible information sources about prescription drugs are based on a drug s Product Information, the document approved by Australia s drug regulation authority, the Therapeutic Goods Administration (TGA). 

Two separate branches of the Department of Health and Family Services determine which medicines are approved for use in Australia and which will be subsidized via the PBS. The Therapeutic Goods Administration is responsible for assessing medicines for quality, safety, and... 

Australian code of good wholesaling practice for therapeutic goods for human use. Woden, Australia, Therapeutic Goods Administration, 1991. 

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