{"id":1130,"slug":"赴韩之前-怎么核实这家医院和这支细胞产品是不是合规的","question":"赴韩之前，怎么核实这家医院和这支细胞产品是不是合规的？","intent":"transactional","language":"zh","url":"https://worldwiki.io/q/赴韩之前-怎么核实这家医院和这支细胞产品是不是合规的","entity":{"slug":"regenerative-medicine","name":"Regenerative Medicine","url":"https://worldwiki.io/entity/regenerative-medicine"},"answer":{"short_answer":"韩国的监管分工是：保健福祉部负责医疗机构的指定，食品医药品安全处（MFDS）负责产品与细胞处理设施。[1] 因此要分别核实「机构是否被指定」和「这支产品是否获批或已进入合规的临床研究」，两者缺一不可。美国 FDA 提醒，产品在 ClinicalTrials.gov 登记或在监管机构备案，都不等于获得批准，这个判断原则同样适用于阅读韩国机构的宣传材料。[2][6]","detailed_answer":"<p>出发前建议索取并保留的书面材料：</p><ul><li>机构名称与指定/许可编号，可向保健福祉部与 MFDS 对照查询；[1]</li><li>所用产品的名称、细胞来源、处理方式，以及批准文号或临床研究编号；</li><li>如属临床研究，应有知情同意书与伦理审查信息；</li><li>不良反应处理与随访安排。</li></ul><p>资料中<strong>未公布</strong>：是否提供中文病历、中文知情同意书或中文陪同翻译，这些需直接向机构书面确认。FDA 的患者与消费者信息页面列出了在接受此类治疗前应向医生提出的问题，可作为提问清单参考。[6]</p>","format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"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","accessed_at":"2026-09-18 18:00:01"},{"id":2,"title":"FDA Warns About Stem Cell Therapies","url":"https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-15 01:35:59"},{"id":96,"title":"Important Patient and Consumer Information About Regenerative Medicine Therapies","url":"https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:38"}],"published_at":"2026-09-20 08:11:10"}