Enforcement record
指定 disclosure naming 大日本住友製薬株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
指定
Law
Pharmaceutical Affairs Act
Authority
Ministry of Health, Labour and Welfare
Action date
28 February 2017
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-OTHER-DA-RI-BEN-Z-202608041732
- Generated at
- 5 August 2026 at 02:32
- Record URL
- https://regbase.jp/en/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20170228
1. Review Summary
| Disclosure name | 大日本住友製薬株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 28 February 2017 | Authority | Ministry of Health, Labour and Welfare |
| Law | Pharmaceutical Affairs Act | Action type | 指定 |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | 大日本住友製薬株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | 大日本住友製薬株式会社 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Pharmaceutical Affairs Act / 指定 |
| Action / announcement date | Action: 28 February 2017 / Announcement: 7 April 2026 |
| English summary | 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. |
| 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。 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000153128.html |
| Source archive | https://kiroku.today/a/60d0baf7afhg2xss |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:13 / Evidence checked: 25 April 2026 at 09:13 / Archive captured: 12 July 2026 at 16:04 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
Save the disclosure record naming 大日本住友製薬株式会社
Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.
Preserved evidence by Kiroku
Review the preserved source for 大日本住友製薬株式会社
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
For developers: JSON integration details
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Action summary
- Company
- 大日本住友製薬株式会社Japanese onlyOriginal: 大日本住友製薬株式会社
- Governing law
- Pharmaceutical Affairs Act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 Pharmaceutical Affairs Act.
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
- 2026-07-12T07:04:38.252332+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": null,
"corporate_number": null,
"law": {
"ja": "薬事法",
"en": "Pharmaceutical Affairs Act"
},
"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": "unresolved",
"confidence": 60,
"method": "extracted_japanese_name",
"method_label": "Company name extracted from the Japanese public disclosure",
"notes": "The linked company profile has not been verified under the current identity policy."
},
"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 Pharmaceutical Affairs Act."
},
"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",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/60d0baf7afhg2xss",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
"archiveCapturedAt": "2026-07-12T07:04:38.252332+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": "2026-08-04T17:32:49.679Z"
},
"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)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.