대한의용생체공학회:의공학회지 (Journal of Biomedical Engineering Research)

  • 제44권6호
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  • Pages.414-427
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  • 2023
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  • 1229-0807(pISSN)
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  • 2288-9396(eISSN)
대한의용생체공학회 (The Korean Society of Medical and Biological Engineering)
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이식형 흡수성 융복합 의료제품 규제 비교 연구 -미국, 유럽, 한국을 중심으로-

A Comparative Study on the Regulations on Implantable Bioabsorbable Combination Products -Focusing on the U.S., Europe and Korea-

  • 이현정 (아주대학교 융복합의료제품 촉진지원센터) ;
  • 김미혜 (아주대학교 융복합의료제품 촉진지원센터) ;
  • 설주은 (아주대학교 융복합의료제품 촉진지원센터) ;
  • 김수동 (아주대학교 산학협력단) ;
  • 김주희 (아주대학교 융복합의료제품 촉진지원센터)
  • Hyeon Jeong Lee (Regulatory Strategy center for Combination Product (RSCP)) ;
  • Mi Hye Kim (Regulatory Strategy center for Combination Product (RSCP)) ;
  • Ju Eun Seol (Regulatory Strategy center for Combination Product (RSCP)) ;
  • Su Dong Kim (Industry-Academic Cooperation Foundation, Ajou University) ;
  • Joo Hee Kim (Regulatory Strategy center for Combination Product (RSCP))
  • 투고 : 2023.11.10
  • 심사 : 2023.12.05
  • 발행 : 2023.12.31
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초록

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

키워드

과제정보

본 연구는 식품의약품안전처의 「융복합 의료제품 안전기술 촉진지원 연구(식약처_21153 인프라431)」 연구 개발비로 수행되었으며 이에 감사드립니다.

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