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KMID : 1011120190130010001
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Bioethics Policy Studies
2019 Volume.13 No. 1 p.1 ~ p.18
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A Study on the Regulatory framework for approval of Combination products in Korea
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Lee Mi-Young
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Abstract
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With the progress of technology, new medical products are being developed that have a combined composition and use that cannot be easily classified into existing medicines, medical devices, and quasi-drugs. Among these new medical products, drugs-medical devices, biologics-medical devices, drugs-biologics, or drugs-biologics, it is necessary to establish the legal basis for efficient and rational safety management for combination medical products, which are combined products of two or more different types. I would review the current status and problems of the definition and licensing process for combination medical products under domestic legislation comparing newly amended law in US, and suggest legislative tasks for improvement.
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KEYWORD
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drug,, device, combination products, advanced therapy combination products
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FullTexts / Linksout information
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Listed journal information
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