Possible 指定 against 大日本住友製薬 株式会社
For developers: integration details
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/api/v1/enforcements?company=%E5%A4%A7%E6%97%A5%E6%9C%AC%E4%BD%8F%E5%8F%8B%E8%A3%BD%E8%96%AC%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10Action summary
- Company
- 大日本住友製薬 株式会社Japanese originalOriginal: 大日本住友製薬株式会社
- Entity match
- Possible entity match60/100Machine extractedCompany name extracted from the Japanese public disclosure
- Governing law
- 薬事法薬事法
- Action type
- 指定指定
- Action date
- 28 February 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
This concerns Parkinson's disease treatment using non-autologous iPS cell-derived dopamine neural precursor cells, which have a different mechanism of action from conventional treatments. Although there is no clinical experience, non-clinical efficacy evaluations have reported significant symptom improvement (more than 40% in motor symptom scores) from six months after transplantation, as well as dopamine synthesis and reuptake activity (PET imaging) at the transplantation site in the brain.
Show original Japanese text
非自己iPS細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療であり、従来の治療法とは異なる作用機序を有する。臨床使用経験はないが、非臨床有効性評価により、移植6か月後から症状の有意な改善(運動症状スコア40%以上)と脳内移植部位でドパミン合成及びドパミン再取込み活性(PET画像)が認められたとの報告がある。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under 薬事法.
Review the original Japanese source and determine relevance to your counterparty-risk workflow.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-25T00:13:59.624+00:00
- Evidence checked
- 2026-04-25T00:13:59.624+00:00
- Archive captured
- 2026-04-07T12:02:10.874+00:00
Show audit JSON
{
"record": {
"id": "3a33e33b-7d77-4993-a812-cb180f702ae2",
"url": "https://regbase.jp/en/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20170228",
"company_name_original": "大日本住友製薬株式会社",
"company_name_registry": "大日本住友製薬 株式会社",
"corporate_number": null,
"law": {
"ja": "薬事法",
"en": "薬事法"
},
"action_type": {
"ja": "指定",
"en": "指定"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "possible",
"confidence": 60,
"method": "extracted_japanese_name",
"method_label": "Company name extracted from the Japanese public disclosure",
"notes": null
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Context needed",
"actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
"practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
"lawContext": "Japanese regulatory disclosure under 薬事法."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20170228",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
"archiveUrl": "https://kiroku.today/view/60d0baf7afokk4is",
"archiveCapturedAt": "2026-04-07T12:02:10.874+00:00",
"extractedAt": "2026-04-25T00:13:59.624+00:00",
"translatedAt": "2026-05-01T07:03:45.884+00:00",
"evidenceCheckedAt": "2026-04-25T00:13:59.624+00:00",
"generatedAt": "2026-06-19T10:32:17.744Z"
},
"limitations": [
"RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
"English summaries are provided for reference. The original Japanese source is authoritative.",
"Possible or unresolved entity matches should be manually verified before use in a decision."
]
}The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.
Language
日本語版を見る (Japanese)Company info
- English name
- 大日本住友製薬 株式会社 Japanese original
- Japanese name
- 大日本住友製薬 株式会社
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.