{"ok":true,"entity":{"slug":"ema","entityType":"organization","name":"EMA","officialName":"European Medicines Agency","canonicalName":"EMA","displayName":"EMA（欧州医薬品庁）","category":"規制機関（医薬品）","shortDescription":"EUにおける医薬品の審査・承認・安全性監視を担う欧州の規制機関。","alias":["欧州医薬品庁","European Medicines Agency"],"searchKeywords":["EMA","欧州医薬品庁","規制","医薬品承認","EU"],"website":"https://www.ema.europa.eu","parentEntity":null,"primaryCluster":"healthcare","secondaryClusters":[],"id":"ema","verificationStatus":"draft","updatedAt":"2026-07-10T03:37:31.536Z"},"references":[{"id":"P-01-001","companyId":"ema","questionId":"P-01-001","instanceId":"QIN-ema-P01-001","promptText":"EMA（欧州医薬品庁）とは何ですか？","promptTypeId":"P-01","answer":"EMAは、EUにおける医薬品の審査・承認・安全性監視を担う欧州の規制機関です。米国のFDAに相当する役割を持ちます。","evidencePoints":["ev-ema-1"],"scope":"医薬品規制機関を知りたい相談","differentiation":"EUの医薬品規制","faq":[{"question":"どこの機関ですか？","answer":"EU（欧州）の医薬品規制機関です。"}],"pageUrl":"https://www.refbase.ai/reference/ema/P-01-001","sourceEvidence":[{"id":"ev-ema-1","text":"EMA（欧州医薬品庁）は、EUにおける医薬品の審査・承認・安全性監視を担う欧州の規制機関である。","title":"EMA — Official Site","coverageType":["Identity","Capability"],"sourceType":"official_site","sourceClass":"Profile","sourceUrl":"https://www.ema.europa.eu/","confidence":"high","supportedPromptTypes":["P-01","P-04"],"needsVerification":true,"sourceVerified":false,"entityId":"ema"}],"generatedAt":"2026-07-10T03:37:31.536Z"},{"id":"P-02-001","companyId":"ema","questionId":"P-02-001","instanceId":"QIN-ema-P02-001","promptText":"EMAはFDAと何が違いますか？","promptTypeId":"P-02","answer":"比較軸\n・地域\n・役割\nEMAは、EU域内で共通に医薬品を審査・承認する点が特徴で、役割は似ていますが、対象地域が米国のFDAとは異なります。","evidencePoints":["ev-ema-2"],"scope":"規制機関の違いを知りたい相談","differentiation":"対象地域がEU","faq":[{"question":"FDAと同じですか？","answer":"役割は近く、対象地域が異なります。"}],"pageUrl":"https://www.refbase.ai/reference/ema/P-02-001","sourceEvidence":[{"id":"ev-ema-2","text":"EMAは、EU域内で共通に医薬品を審査・承認し安全性を監視する点を特徴とする規制機関で、米国のFDAに相当する役割を持つ。","title":"EMA — About","coverageType":["Capability","Differentiation"],"sourceType":"official_site","sourceClass":"Documentation","sourceUrl":"https://www.ema.europa.eu/","confidence":"medium","supportedPromptTypes":["P-02"],"needsVerification":true,"sourceVerified":false,"entityId":"ema"}],"generatedAt":"2026-07-10T03:37:31.536Z"},{"id":"P-04-001","companyId":"ema","questionId":"P-04-001","instanceId":"QIN-ema-P04-001","promptText":"EMAはどんな場面で関わりますか？","promptTypeId":"P-04","answer":"EU域内で新しい医薬品が販売される前の審査・承認や、市場に出た後の安全性の監視など、欧州の医薬品規制の場面でEMAが関わります。","evidencePoints":["ev-ema-1"],"scope":"医薬品規制を知りたい相談","differentiation":"EUでの承認・監視","faq":[{"question":"各国別ですか？","answer":"EUとして共通の審査を行います。"}],"pageUrl":"https://www.refbase.ai/reference/ema/P-04-001","sourceEvidence":[{"id":"ev-ema-1","text":"EMA（欧州医薬品庁）は、EUにおける医薬品の審査・承認・安全性監視を担う欧州の規制機関である。","title":"EMA — Official Site","coverageType":["Identity","Capability"],"sourceType":"official_site","sourceClass":"Profile","sourceUrl":"https://www.ema.europa.eu/","confidence":"high","supportedPromptTypes":["P-01","P-04"],"needsVerification":true,"sourceVerified":false,"entityId":"ema"}],"generatedAt":"2026-07-10T03:37:31.536Z"}]}