{"id":33,"slug":"cell-processing-facility","name":"Cell Processing Facility","alternate_names":["세포처리시설"],"aliases":[],"locale":"en","available_locales":["en"],"localized":false,"type":"concept","description":"A cell processing facility is a licensed laboratory where human cells are collected, processed and stored under regulated conditions for clinical use.","overview":"A cell processing facility (세포처리시설) is a site licensed under South Korea's Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act, which took effect on 28 August 2020. It collects human cells, tests and processes them, and supplies them to institutions that carry out advanced regenerative medicine. Operators must meet facility, staffing and equipment standards set by presidential decree and obtain a licence from the Ministry of Food and Drug Safety (MFDS). Eligible operators include government bodies, hospitals, drug and device manufacturers, cord blood banks and corporations set up for cell processing. Facilities must keep processing records and report regularly. The Ministry of Health and Welfare separately designates the institutions that perform the procedures. Readers should check a facility's current licence on the KARM portal or with MFDS.","official_url":null,"image_url":null,"country":null,"region":null,"wikidata_id":null,"wikipedia_url":null,"verified":false,"scores":{"authority":52,"trust":0,"citation":0},"topic":{"slug":"regenerative-medicine","name":"Regenerative Medicine"},"url":"https://worldwiki.io/entity/cell-processing-facility","facts":[{"id":370,"predicate":"definition","label":"Definition","value":"A facility that collects human cells, inspects and processes them, and supplies them to institutions performing advanced regenerative medicine","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":371,"predicate":"legal_basis","label":"Legal basis","value":"Article 15, Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":372,"predicate":"effective_date","label":"Licensing regime in force since","value":"2020-08-28 (Law No. 16556, enacted 2019-08-27)","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":373,"predicate":"eligible_applicants","label":"Who may apply for a licence","value":"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 decree","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":374,"predicate":"alternative_route","label":"Deemed licence","value":"Holders of a human cell management business licence (Article 28) can notify MFDS and are then treated as licensed","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":375,"predicate":"record_keeping","label":"Record-keeping duty","value":"The facility head must keep cell processing records and report regularly to the Advanced Regenerative Medicine safety management agency","unit":null,"confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":376,"predicate":"closure_reporting","label":"Closure or suspension reporting","value":"Report within 7 days. No report is needed for a suspension of less than one month","unit":"days","confidence":80,"valid_from":null,"valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[88]},{"id":377,"predicate":"detailed_standards","label":"Detailed standards","value":"MFDS Notice No. 2020-81 (Regulation on Licensing and Safety of Human Cells and Advanced Biopharmaceuticals). Facility, equipment and staffing standards are in Annex 1","unit":null,"confidence":80,"valid_from":"2020-09-03","valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[90]},{"id":378,"predicate":"licensed_facility_count","label":"Licensed facilities listed on the KARM portal","value":"54 (most recent listed licence dated 2026-05-11)","unit":"facilities","confidence":80,"valid_from":"2026-09-18","valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[305]},{"id":379,"predicate":"institution_designation","label":"Designation of performing institutions","value":"The Minister of Health and Welfare designates advanced regenerative medicine institutions under Article 10 of the Act. Applications for 2025 ran from 2025-04-28 to 2025-12-12","unit":null,"confidence":80,"valid_from":"2025-04-25","valid_until":null,"verified_at":"2026-09-18 07:30:08","source_ids":[306]},{"id":58,"predicate":"authority_kr","label":"Permission authority (Korea)","value":"Ministry of Food and Drug Safety","unit":null,"confidence":100,"valid_from":null,"valid_until":null,"verified_at":"2026-09-15 01:35:59","source_ids":[3]}],"relations":[{"type":"related_to","confidence":100,"target":{"id":14,"slug":"regenerative-medicine","name":"Regenerative Medicine","type":"concept","description":"Regenerative medicine is a field that aims to repair, replace or regenerate damaged cells, tissues or organs, using approaches such as cell therapy, tissue engineering and biomaterials.","url":"https://worldwiki.io/entity/regenerative-medicine"}},{"type":"licensed_by","confidence":100,"target":{"id":48,"slug":"ministry-of-food-and-drug-safety","name":"식품의약품안전처 (Ministry of Food and Drug Safety)","type":"organization","description":"South Korea’s regulator for medicines, medical devices and cell-based products, and the authority that permits cell processing facilities under the Advanced Regenerative Bio Act.","url":"https://worldwiki.io/entity/ministry-of-food-and-drug-safety"}}],"questions":[{"slug":"세포처리시설-허가는-어디서-받나요","question":"세포처리시설 허가는 어디서 받나요?","intent":"provider","language":"ko","short_answer":"한국에서 첨단재생의료용 세포처리시설 허가는 식품의약품안전처가 합니다. 첨단재생바이오법 제15조에 따르면 인체세포등을 채취·검사·처리해 재생의료기관에 공급하려는 자는 시행령으로 정한 시설·장비·인력을 갖춰 식약처장의 허가를 받아야 합니다. 신청할 수 있는 자는 의료기관 개설자, 의약품·의료기기 제조업자, 제대혈은행, 세포처리 관련 법인 등입니다. 반면 첨단재생의료를 실시하는 의료기관은 보건복지부의 지정을 받습니다.","url":"https://worldwiki.io/ko/q/세포처리시설-허가는-어디서-받나요"},{"slug":"세포처리시설-허가-현황은-어디서-확인하나요","question":"세포처리시설 허가 현황은 어디서 확인하나요?","intent":"provider","language":"ko","short_answer":"보건복지부가 운영하는 첨단재생의료포털(k-arm.go.kr)에 세포처리시설 현황과 재생의료기관 정보 메뉴가 있습니다. 같은 포털에서 임상연구와 치료계획의 심의 상황도 볼 수 있습니다. 명단은 신규 허가, 갱신, 휴·폐업에 따라 바뀔 수 있습니다. 특정 시설의 허가 상태가 불분명하면 허가 기관인 식품의약품안전처에 직접 문의하는 방법이 확실합니다.","url":"https://worldwiki.io/ko/q/세포처리시설-허가-현황은-어디서-확인하나요"},{"slug":"첨단재생의료실시기관과-세포처리시설의-차이는-무엇인가요","question":"첨단재생의료실시기관과 세포처리시설의 차이는 무엇인가요?","intent":"informational","language":"ko","short_answer":"첨단재생의료실시기관(재생의료기관)은 첨단재생의료 임상연구와 치료를 실시하는 의료기관으로, 보건복지부장관의 지정을 받습니다. 세포처리시설은 그 기관에 쓰일 인체세포등을 채취·검사·처리해 공급하는 곳으로, 식품의약품안전처장의 허가를 받습니다. 재생의료기관은 원칙적으로 허가받은 세포처리시설에서 공급받은 세포로만 첨단재생의료를 해야 합니다. 법에 정한 일부 유형에서만 자체 처리한 세포를 쓸 수 있습니다.","url":"https://worldwiki.io/ko/q/첨단재생의료실시기관과-세포처리시설의-차이는-무엇인가요"},{"slug":"세포처리시설-허가는-몇-년마다-갱신하나요","question":"세포처리시설 허가는 몇 년마다 갱신하나요?","intent":"informational","language":"ko","short_answer":"첨단재생바이오법 제15조 제6항에 따라 세포처리시설은 3년마다 허가증을 갱신해야 합니다. 폐업하거나 휴업할 때, 또는 휴업했던 업무를 다시 시작할 때는 7일 이내에 식약처장에게 신고해야 합니다. 다만 휴업 기간이 1개월 미만이면 신고하지 않아도 됩니다. 식약처는 2026년 1월 갱신과 휴·폐업, 폐업 뒤 자료 이관 절차를 정리한 안내자료를 공개했습니다.","url":"https://worldwiki.io/ko/q/세포처리시설-허가는-몇-년마다-갱신하나요"},{"slug":"병원이-직접-세포를-처리해서-첨단재생의료를-할-수-있나요","question":"병원이 직접 세포를 처리해서 첨단재생의료를 할 수 있나요?","intent":"provider","language":"ko","short_answer":"원칙적으로는 할 수 없습니다. 재생의료기관은 식약처 허가를 받은 세포처리시설에서 공급받은 인체세포등을 써야 합니다. 다만 법 제2조 제3호 다목에 해당하는 임상연구나 제5호 다목에 해당하는 치료에서는 보건복지부령에 따라 기관이 직접 처리한 세포를 쓸 수 있습니다. 또 2024년 개정으로 환자 본인의 세포를 최소한으로 조작해 원료로 공급하는 경우 재생의료기관을 인체세포등 관리업 허가를 받은 것으로 보는 규정이 생겼습니다.","url":"https://worldwiki.io/ko/q/병원이-직접-세포를-처리해서-첨단재생의료를-할-수-있나요"}],"sources":[{"id":3,"title":"Ministry of Food and Drug Safety — English site","url":"https://www.mfds.go.kr/eng/","publisher":"MFDS, Republic of Korea","type":"government","publication_date":null,"accessed_at":"2026-09-21 18:00:06"},{"id":88,"title":"첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)","url":"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","publisher":"CaseNote (법령 원문)","type":"other","publication_date":null,"accessed_at":"2026-11-09 18:00:46"},{"id":90,"title":"인체세포등 및 첨단바이오의약품의 허가 및 안전 등에 관한 규정 전문","url":"https://www.bioin.or.kr/board/system/305422","publisher":"생명공학정책연구센터(BioIN)","type":"organization","publication_date":"2021-03-15","accessed_at":"2026-11-11 18:01:15"},{"id":305,"title":"세포처리시설 현황 — 첨단재생의료세포처리시설 허가 기관 목록","url":"https://www.k-arm.go.kr/sub.do?key=2109297512639","publisher":"첨단재생의료·첨단바이오의약품 포털 (보건복지부)","type":"government","publication_date":null,"accessed_at":"2026-11-09 18:01:04"},{"id":306,"title":"2025년도 첨단재생의료실시기관 지정 신청 공고","url":"https://www.mohw.go.kr/board.es?mid=a10501010100&bid=0003&act=view&list_no=1485494&tag=&nPage=1","publisher":"Ministry of Health and Welfare, Republic of Korea","type":"government","publication_date":"2025-04-25","accessed_at":"2026-11-09 18:00:45"}],"providers":[{"slug":"sc301","name":"SC301의원","verified_level":"verified","sponsored":false,"featured":false,"country":"KR","city":"Seoul","url":"https://worldwiki.io/provider/sc301"}],"published_at":"2026-09-14 13:42:07","updated_at":"2026-11-12 05:20:00","verified_at":null}