{"id":1132,"slug":"中介说这款疗法-获得美国fda的rmat认定-是不是等于已经批准上市","question":"中介说这款疗法「获得美国FDA的RMAT认定」，是不是等于已经批准上市？","intent":"commercial","language":"zh","url":"https://worldwiki.io/q/中介说这款疗法-获得美国fda的rmat认定-是不是等于已经批准上市","entity":{"slug":"regenerative-medicine","name":"Regenerative Medicine","url":"https://worldwiki.io/entity/regenerative-medicine"},"answer":{"short_answer":"不是。RMAT（再生医学先进疗法认定）依据《21 世纪治愈法案》第 3033 条设立，条件是该再生医学疗法针对严重或危及生命的疾病，并具备可满足未被满足医疗需求的初步临床证据。[5] 它是一种加快沟通与审评的认定资格，不是上市批准。FDA 同时明确指出，在 ClinicalTrials.gov 登记或在 FDA 备案都不代表产品已获批准。[2][6]","detailed_answer":"<p>按《联邦食品、药品和化妆品法》第 506(g) 条，可获 RMAT 认定的范围包括：细胞治疗、治疗性组织工程产品、人体细胞与组织产品或其组合；某些人类基因治疗和异种细胞产品也可能符合条件。[5]</p><p>阅读宣传时建议区分三件事：<strong>认定（designation）</strong>、<strong>临床试验登记</strong>、<strong>上市批准</strong>。前两者都不能推出第三者。[2][5][6] 若对方无法提供产品名称与批准文号，应视为未获批准的产品。</p>","format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"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":250,"title":"Regenerative Medicine Advanced Therapy Designation","url":"https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-19 18:00:20"},{"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"}