Administrative Guidance against モデルナ・ジャパン株式会社

モデルナ・ジャパン株式会社 (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Ministry of Health, Labour and WelfareConfirmed entity match1 November 2022
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/api/v1/enforcements?corporate_number=4010401159678&limit=10

Action summary

Company
Original: モデルナ・ジャパン株式会社
Corporate Number: 4010401159678
Entity match
Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
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

Machine-translated summary — verify against original

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-medium

Administrative 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.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
Extracted at
2026-04-25T00:21:06.955+00:00
Evidence checked
2026-04-25T00:21:06.955+00:00
Archive captured
2026-04-10T00:01:55.953+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": "モデルナ・ジャパン株式会社",
    "corporate_number": "4010401159678",
    "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": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "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",
    "archiveUrl": "https://kiroku.today/view/b65dc91e50s55lf7",
    "archiveCapturedAt": "2026-04-10T00:01:55.953+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": "2026-06-28T16:49:27.322Z"
  },
  "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.

Company info

English name
モデルナ・ジャパン株式会社 Japanese original
Japanese name
モデルナ・ジャパン株式会社
Corporate Number
4010401159678
Registered address
東京都港区虎ノ門4丁目1番1号
See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.