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Regulatory Focus™ > News Articles > Analysis of the Orphan Drug Program in Australia

Analysis of the Orphan Drug Program in Australia

Posted 01 January 2011 | By Brian Creese 

Australia's Orphan Drug Program was introduced in 1998.1 The aim of the program is to encourage sponsors to develop and market medicines for the treatment, prevention and diagnosis of rare diseases. Australia's federal government recognizes that pharmaceutical companies are reluctant to develop such products because the financial return is small compared to the development and marketing costs. The Orphan Drug Program was designed to address this problem and to ensure that patients with rare diseases have access to drugs of the same quality, efficacy and safety as patients with common illnesses. The legislative basis for the program is Part 3B of the Therapeutic Goods Regulations of 1990.2 The program is administered by the Therapeutic Goods Administration (TGA).


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