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KMID : 1142220060010020025
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Regulatory Research on Food, Drug & Cosmetic
2006 Volume.1 No. 2 p.25 ~ p.27
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Approval Process of Biopharmaceuticals
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Yoo Moo-Young
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Abstract
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Development of new biopharmaceuticals using the cutting-edge of biotechnology widens the possibility to cure the rare and/or intractable diseases. International competitiveness in this promising, so-called “BT” industry is determined by various factors: the fundamental science and technology, the capital strength for research and development, the social infrastructure necessary for industrializing process, the assessment competency for safety and efficacy of the products, etc. This paper explains the general challenges on the hereafter industrialization of biotechnological products and the related initiatives of KFDA (Korea Food and Drug Administration).
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KEYWORD
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biopharmaceuticals, biotechnological products, biotechnological medicines, approval process, KFDA(Korea Food and Drug Administration)
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