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KMID : 1142220070020010001
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Regulatory Research on Food, Drug & Cosmetic
2007 Volume.2 No. 1 p.1 ~ p.12
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Benchmarking of FDA on Drug Evaluation
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Lee Sun-Hee
Lee Su-Jung
Kang Ju-Hye
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Abstract
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The implementation of advanced approval process in Korea would be effectively accomplished by understanding the regulatory pathway of US FDA that is internationally good example of drug apporoving authority. In this study, the organization and personnel, approval system and related guidelines, submission fee, and review period of KFDA were compared with FDA CDER. In addition, the procedures in disclosure of information and training programs were introduced, and the method of benchmarking and possible strategies to improve the review process in KFDA were proposed. In conclusion, this paper reveals the current review process and possible future plans for establishing the advanced review process in Korea.
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KEYWORD
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FDA, CDER, Benchmarking, GRMP(Good Review Management Practice), SOP, FDA, CDER, benchmarking, GRMP (Good Review Management Practice), submission fee, SOP, disclosure of information, training
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FullTexts / Linksout information
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Listed journal information
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