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첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)

CaseNote (법령 원문)

accessed Sep 18, 2026Updated Sep 19, 2026
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https://casenote.kr/%EB%B2%95%EB%A0%B9/%EC%B2%A8%EB%8B%A8%EC%9E%AC%EC%83%9D%EC%9D%98%EB%A3%8C_%EB%B0%8F_%EC%B2%A8%EB%8B%A8%EB%B0%94%EC%9D%B4%EC%98%A4%EC%9D%98%EC%95%BD%ED%92%88_%EC%95%88%EC%A0%84_%EB%B0%8F_%EC%A7%80%EC%9B%90%EC%97%90_%EA%B4%80%ED%95%9C_%EB%B2%95%EB%A5%A0/%EC%A0%9C15%EC%A1%B0

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Cited by (16)

FactCell Banking: Korea: cell processing facility approval = Cell processing requires MFDS approval as an advanced regenerative medicine cell processing facility, and the licence must be renewed every 3 years (Advanced Regenerative Bio Act, Art. 15).FactCell Processing Facility: Definition = A facility that collects human cells, inspects and processes them, and supplies them to institutions performing advanced regenerative medicineFactCell Processing Facility: Legal basis = Article 15, Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced BiopharmaceuticalsFactCell Processing Facility: Licensing regime in force since = 2020-08-28 (Law No. 16556, enacted 2019-08-27)FactCell Processing Facility: Who may apply for a licence = National or local governments, medical institutions, drug manufacturers, medical device manufacturers, cord blood banks, corporations set up mainly for cell processing, and others named by presidential decreeFactCell Processing Facility: Deemed licence = Holders of a human cell management business licence (Article 28) can notify MFDS and are then treated as licensedFactCell Processing Facility: Record-keeping duty = The facility head must keep cell processing records and report regularly to the Advanced Regenerative Medicine safety management agencyFactCell Processing Facility: Closure or suspension reporting = Report within 7 days. No report is needed for a suspension of less than one month daysAnswer세포처리시설 허가는 어디서 받나요?Answer세포처리시설 허가 현황은 어디서 확인하나요?Answer첨단재생의료실시기관과 세포처리시설의 차이는 무엇인가요?Answer세포처리시설 허가는 몇 년마다 갱신하나요?Answer병원이 직접 세포를 처리해서 첨단재생의료를 할 수 있나요?Answer첨단재생의료란 무엇이며 국내에서는 어떻게 관리되나요?Answer재생의료 시술은 어디에서 받아야 안전한가?Article세포처리시설(Cell Processing Facility): 정의·허가 요건·재생의료기관과의 관계·허가 확인 방법