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KMID : 1142220090040010039
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.39 ~ p.43
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Ensuring the Quality of Narcotic Drugs
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Park Eun-Hye
Yun Mi-Ok
Jung Ju-Yeon
Song Yun-Kyoung
Lee Ji-Hyun
Um Jung-Yoon
Nam Seung-Yeon
Woo Sun-Wook
Kim Dae-Byoung
Kim In-Kyu
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Abstract
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Narcotics, despite of its danger on abuse, are known as effective drugs that contribute in the treatment of many diseases. Therefore Korea Food and Drug Administration enforces a strict system on approval procedures and quality assurance of narcotic drugs. In this study, definition on narcotics, approval procedures, quality assurance, manufacture and distribution of narcotic reference standards, and recent status of cooperation among Korean government agencies on nacrotics were discussed and summarized.
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KEYWORD
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Narcotic drugs, Approval and review, Narcotic reference standard, Korea Food and Drug Administration (KFDA)
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