인체세포ㆍ조직이용 의료제품 등의 규제에 관한 국내외 규정 비교 및 안전관리 개선방안 연구

• 영문명: Comparative studies on the regulations of human cellular and tissue-based medical products for improvement of safety management
• 발행기관: 대한약학회
• 저자명: 이지훈(Jihoon Lee) 최수경(Soo Kyung Choi) 김주희(Juhui Gim) 박미영(Miyoung Park) 박수현(Soo Hyun Park) 최진희(Jinhee Choi) 임화경(Hwakyung Lim) 노혜민(Hyemin Noh) 이윤희(Yun hee Lee) 윤재석(Jaesuk Yun)
• 간행물 정보: 『약학회지』제62권 제3호(2018년), 186~194쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2018.06.30

영문 초록

Over the past several decades, human-derived cells, tissues, and cell- and tissue-based therapies have contributed to essential body function regeneration in the absence of effective alternative medicine substitute. This study reviewed strength and weakness of the regulation related to human-derived cells, tissues based pharmaceutical products compared to the US regulation, and suggested points for improvement classified into three categories. First, it is necessary to supplement regulations and guidelines on donor eligibility for pharmaceutical products. Second, there is a need to integrate regulations related to classify pharmaceutical product into biologics, device, and combination products. Finally, there is a need to develop and supplement the traceability of biological traces and the regulations for biological monitoring systems of pharmaceutical products. Collectively, it would be necessary to revise the regulations and the guidelines for the approval, manufacture, management and tracking of human cell/tissue derived pharmaceutical products by collecting opinions from researchers, industry, and clinical health care workers with a systematic long-term goal.

목차

Abstract

서론(Introduction)

실험 방법(Experimental Methods)

결과 및 고찰(Results and Discussion)

결론(Conclusion)

References