Cell Processing Facility
يعرف أيضا باسم: 세포처리시설
A cell processing facility is a licensed laboratory where human cells are collected, processed and stored under regulated conditions for clinical use.
첨단재생의료실시기관과 세포처리시설의 차이는 무엇인가요?
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.
حقائق أساسية
| المحمول | القيمة | المصدر |
|---|---|---|
| Definition | A facility that collects human cells, inspects and processes them, and supplies them to institutions performing advanced regenerative medicine | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| Legal basis | Article 15, Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| Licensing regime in force since | 2020-08-28 (Law No. 16556, enacted 2019-08-27) | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| 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 decree | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| Deemed licence | Holders of a human cell management business licence (Article 28) can notify MFDS and are then treated as licensed | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| Record-keeping duty | The facility head must keep cell processing records and report regularly to the Advanced Regenerative Medicine safety management agency | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| Closure or suspension reporting | Report within 7 days. No report is needed for a suspension of less than one month days | [2]other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)CaseNote (법령 원문) |
| Detailed standards | MFDS Notice No. 2020-81 (Regulation on Licensing and Safety of Human Cells and Advanced Biopharmaceuticals). Facility, equipment and staffing standards are in Annex 1حتى تاريخ 3 سبتمبر 2020 | [3]organization인체세포등 및 첨단바이오의약품의 허가 및 안전 등에 관한 규정 전문생명공학정책연구센터(BioIN) |
| Licensed facilities listed on the KARM portal | 54 (most recent listed licence dated 2026-05-11) facilitiesحتى تاريخ 18 سبتمبر 2026 | [4]government세포처리시설 현황 — 첨단재생의료세포처리시설 허가 기관 목록첨단재생의료·첨단바이오의약품 포털 (보건복지부) |
| Designation of performing institutions | 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 2025-12-12حتى تاريخ 25 أبريل 2025 | [5]government2025년도 첨단재생의료실시기관 지정 신청 공고Ministry of Health and Welfare, Republic of Korea |
| Permission authority (Korea) | Ministry of Food and Drug Safety | [1]governmentMinistry of Food and Drug Safety — English siteMFDS, Republic of Korea |
نظرة عامة
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.
مزودون موثقون
القوائم المدفوعة موسومة بوضوح. التحقق مستقل عن الدفع.SC301의원
SC301의원 (SC301 Clinic) is a plastic surgery clinic in Gangnam, Seoul, South Korea whose official site presents SVF (stromal vascular fraction) fat grafting for the breast and face, liposuction, lifting and cell banking as its main services.
عرض المزودالمراجع
نسبة المصادر المستقلة 100% (5/5)- المستوى A · governmentMinistry of Food and Drug Safety — English site — MFDS, Republic of Korea · تاريخ الاطلاع 22 سبتمبر 2026 · صفحة الدليل
- المستوى C · other첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설) — CaseNote (법령 원문) · تاريخ الاطلاع 10 نوفمبر 2026 · صفحة الدليل
- المستوى A · organization인체세포등 및 첨단바이오의약품의 허가 및 안전 등에 관한 규정 전문 — 생명공학정책연구센터(BioIN) · تاريخ الاطلاع 12 نوفمبر 2026 · صفحة الدليل
- المستوى A · government세포처리시설 현황 — 첨단재생의료세포처리시설 허가 기관 목록 — 첨단재생의료·첨단바이오의약품 포털 (보건복지부) · تاريخ الاطلاع 10 نوفمبر 2026 · صفحة الدليل
- المستوى A · government2025년도 첨단재생의료실시기관 지정 신청 공고 — Ministry of Health and Welfare, Republic of Korea · تاريخ الاطلاع 10 نوفمبر 2026 · صفحة الدليل