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NTIS 바로가기韓國營養學會誌 = The Korean journal of nutrition., v.43 no.6, 2010년, pp.653 - 660
김주희 (이화여자대학교 식품영양학과) , 김지연 (이화여자대학교 식품영양학과) , 원혜숙 (이화여자대학교 식품영양학과) , 권혜진 (이화여자대학교 식품영양학과) , 권혜영 (이화여자대학교 식품영양학과) , 정혜인 (이화여자대학교 식품영양학과) , 권오란 (이화여자대학교 식품영양학과)
Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medic...
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핵심어 | 질문 | 논문에서 추출한 답변 |
---|---|---|
건강기능식품으로 인정받기 위해 인체적용시험의 최종보고서를 자료로 사용할 때에는 피험자의 인권보호와 시험결과의 신뢰확보를 위하여 무엇의 승인을 받아야 하는가? | ‘건강기능식품’으로 인정받기 위해서는 ‘건강기능식품 기능성원료 인정에 관한 규정’ (식품의약품안전청 고시 제 2010-76호)에 따라 반드시 인체적용시험 자료를 제출하도록 하고 있다. 인체적용시험 자료로는 국내·외 학술지에 발표된 자료 및 미발표된 최종보고서도 사용할 수 있으나, 인체적용시험의 최종보고서를 자료로 사용할 때에는 피험자의 인권보호와 시험결과의 신뢰확보를 위하여 국제 임상 시험 관리기준 (Guideline for Good Clinical Practice by International Conference on Harmonization; ICH GCP)에 따라 윤리위원회 (Institutional review board; IRB)의 승인을 받도록 규정하고 있다.3) | |
건강기능식품이란? | ‘건강기능식품’이란 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조한 식품을 말한다.1) 2004년부터 ‘건강기능식품에 관한 법률’이 시행된 이래로 건강기능식품의 개발은 꾸준히 증가하고 있으며 2008년부터는 법률 개정에 따른 제형 확대로 다양한 형태의 건강기능식품이 개발 됨에 따라 관련 시장은 더욱 성장할 것으로 예측된다. | |
건강기능식품으로 인정받기 위해서는 어떻게 해야하는가? | ‘건강기능식품’으로 인정받기 위해서는 ‘건강기능식품 기능성원료 인정에 관한 규정’ (식품의약품안전청 고시 제 2010-76호)에 따라 반드시 인체적용시험 자료를 제출하도록 하고 있다. 인체적용시험 자료로는 국내·외 학술지에 발표된 자료 및 미발표된 최종보고서도 사용할 수 있으나, 인체적용시험의 최종보고서를 자료로 사용할 때에는 피험자의 인권보호와 시험결과의 신뢰확보를 위하여 국제 임상 시험 관리기준 (Guideline for Good Clinical Practice by International Conference on Harmonization; ICH GCP)에 따라 윤리위원회 (Institutional review board; IRB)의 승인을 받도록 규정하고 있다. |
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Kim MK, Kwon OR, Chun HS, Won HS, Kim JY, Kang BC, Che JW, Han JG, Hong SW, Kim WS, Pee JH, Park HY, Kim HJ. Health Functional Food, Kyomunsa; 2010. p.39-40
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Korean Ministry of Education & National Research Foundation of Korea. Establishing and promoting research ethics: Cases of foreign universities; 2007. p.23-24
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UK. National Patient Safety Agency, National Research Ethics Service. About Research Ethics Commitee. Available from: http://www.nres.npsa.nhs.uk/
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Kim MK, Kwon OR, Chun HS, Won HS, Kim JY, Kang BC, Che JW, Han JG, Hong SW, Kim WS, Pee JH, Park HY, Kim HJ. Health Functional Food, Kyomunsa; 2010, p.33-34
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