Enforcement record
Administrative Guidance disclosure naming モデルナ・ジャパン株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Administrative Guidance
Law
新型コロナウイルス感染症の予防に関する特例承認
Authority
Ministry of Health, Labour and Welfare
Action date
1 November 2022
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Completed archive verified
- Captured: Jul 12, 2026, 04:22 PM JST
“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.
Open the official source links in the section below to review the original disclosure.
Action summary
- Company
- モデルナ・ジャパン株式会社Japanese onlyOriginal: モデルナ・ジャパン株式会社
- Governing law
- 新型コロナウイルス感染症の予防に関する特例承認新型コロナウイルス感染症の予防に関する特例承認
- Action type
- Administrative Guidance行政指導
- Action date
- 1 November 2022
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Today, a special approval was granted for a partial change to the approval of Spikebacks intramuscular injection. The package insert is attached separately.
Show original Japanese text
本日、以下のとおり、スパイクバックス筋注の承認事項一部変更について、特例承認を行いました。なお、添付文書は別添のとおりです。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under 新型コロナウイルス感染症の予防に関する特例承認.
Use as a monitoring signal. Confirm details before treating it as a formal sanction.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive
- Extracted at
- 2026-04-25T00:21:06.955+00:00
- Evidence checked
- 2026-04-25T00:21:06.955+00:00
- Archive captured
- 2026-07-12T07:22:05.304099+00:00
Show audit JSON
{
"record": {
"id": "532f2e6a-a6e9-4564-9661-98101db9d765",
"url": "https://regbase.jp/en/enforcement/other-moderunaziyapan-20221101",
"company_name_original": "モデルナ・ジャパン株式会社",
"company_name_registry": null,
"corporate_number": null,
"law": {
"ja": "新型コロナウイルス感染症の予防に関する特例承認",
"en": "新型コロナウイルス感染症の予防に関する特例承認"
},
"action_type": {
"ja": "行政指導",
"en": "Administrative Guidance"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "unresolved",
"confidence": 85,
"method": "nta_strict_name_nationally_unique",
"method_label": "nta_strict_name_nationally_unique",
"notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (モデルナ・ジャパン株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Low-medium",
"actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
"practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
"lawContext": "Japanese regulatory disclosure under 新型コロナウイルス感染症の予防に関する特例承認."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-moderunaziyapan-20221101",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28919.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/b65dc91e50hgrkma",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28919.html",
"archiveCapturedAt": "2026-07-12T07:22:05.304099+00:00",
"extractedAt": "2026-04-25T00:21:06.955+00:00",
"translatedAt": "2026-05-01T07:09:31.859+00:00",
"evidenceCheckedAt": "2026-04-25T00:21:06.955+00:00",
"generatedAt": "2026-09-18T20:01:37.494Z"
},
"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.