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KMID : 0941820060160020107
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Korean Journal of Clinical Pharmacy
2006 Volume.16 No. 2 p.107 ~ p.112
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Current Status and Expectations of Orphan Drug in Korea -In point of supplying medicines for the rare diseases
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Kim Hee-Eun
Gwak Hye-Sun
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Abstract
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This study was aimed to investigate the current status and expectations of orphan drugs in Korea. The Korea Orphan Drug Center was established to supply many medicines for the patients with rare diseases. Among the medicines supplied by the Center, the number desigenated as the orphan drugs by the KFDA is quite few. However, a few of medicines are not under circulation even if the items are designated as the orphan drugs. Neoplasm-realated medicines, infectious and parasitic disease-realated medicines, endocrine, nutritional and metabolic disease-related medicines are the ones circulated most. There are several unapproved drugs among the medicines supplied by the center. It’s because the director of the Center can import the goods without a process to getting an approval from the KFDA. The Korea Orphan Drug Center has contributed to the select of the medicines for treating the rare disease. On the contrary, some problems remain in the supply process. The safety and effictiveness of the medicines supplied by the Center are not guaranteed. So far, rare diseases have no specific legal definition, and therefore are only reffered to in terms of the population of patients, which prevent from establishing the range of medicines. The introduction of Special Access Program or Access to Unapproved Therapeutic Goods will be the solution of these problems. In additon, it is another solution to keep intimate relations with the Rare and Intractable Disease Center and the Medicine Safety Information Center which will be open soon.
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KEYWORD
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Orphan Drug, Korea Ophan Drug Center, Rare Disease
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