2001
DOI: 10.1177/009286150103500101
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Orphan Drug Programs/Policies in Australia, Japan, and Canada

Abstract: and Japan have evaluated how their governments can facilitate the development of medical products to treat rare disorders. Each has established programs andor policies to support the development of products to address unmet medical needs in small populations and to ensure their citizens access to such essential medicines.Japan implemented an Orphan Product Program in 1993. Australia 's program, initiated in 1998, was developed in collaboration with the United States Food and Drug Administration to facilitate t… Show more

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Cited by 9 publications
(11 citation statements)
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“…The number of orphan drugs increased from 38 in 1983 to over 500 in 2018. Therefore, similar acts have been established in many other countries and districts, including Japan, European Union, Singapore, South Korea, and Australia [28,29]. Also, patient organizations in China were generally not active in academic research.…”
Section: Discussionmentioning
confidence: 99%
“…The number of orphan drugs increased from 38 in 1983 to over 500 in 2018. Therefore, similar acts have been established in many other countries and districts, including Japan, European Union, Singapore, South Korea, and Australia [28,29]. Also, patient organizations in China were generally not active in academic research.…”
Section: Discussionmentioning
confidence: 99%
“…Most of Japan's orphan drugs are used to treat "infectious diseases (including HIV), haematological diseases, neuromuscular diseases, cancer, diseases of the immune system, and infant-common diseases." Table 3 gives the details about the differences on the Australia and Japan regulatory overview (Scott et al, 2001).…”
Section: Japanmentioning
confidence: 99%
“…3 At the federal level, the former Emergency Drug Release Program (initiated in 1993) approved and released essential drugs, provided no other treatments were available for a condition. 4 A physician could request in writing that, with the approval of Health Canada, a pharmaceutical company be authorized to sell or give a precise amount of a drug that had yet to be approved for marketing or sale.…”
Section: Current Statementioning
confidence: 99%
“…They can also be applied to more direct financial policy, such as tax incentives for drug development or deductions on personal income tax. 3 Canada would be well served to develop a population threshold or prevalence criterion to determine rarity, just as other nations with frameworks have adopted strict operational definitions (Table 1). A proportionate measure with consistent nomenclature (incidence or prevalence) eliminates ambiguity in establishing rarity and allows more strict classification of diseases and their treatments.…”
Section: Key Pointsmentioning
confidence: 99%