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KMID : 1142220060010020005
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Regulatory Research on Food, Drug & Cosmetic
2006 Volume.1 No. 2 p.5 ~ p.14
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The Review of Safety and Efficacy for Biological Products
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Hong Seung-Hwa
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Abstract
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Biological products, in contrast to drugs that are chemically synthesized, are derived from living sources such as humans, animals, and microorganisms. Most biologics are complex mixtures that are not easily identified or characterized. Therefore, biologics are quite different from conventional drugs in aspect of starting materials, manufacturing process and functions of products. Because of characteristics of biologics such as diverse sources, structure, immunogenicity, species specificity, etc., there are some cases to which we cannot apply “Regulation for evaluation of safety and efficacy of drugs”. Taking consideration of biological product specificity, review of products requires evaluating scientific and clinical data submitted by manufacturers to determine whether the product meets “Regulation for approval and review of biological products” for approval. KFDA(Korea Food and Drug Administration) is committed to advancing public health through innovative regulations that ensure the safety, effectiveness of new concept products including gene therapy products, cell and tissue engineering products, biochips and xenotransplantation products.
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KEYWORD
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biological products, safety, efficacy
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