Enforcement record

先駆け審査指定制度対象品目の募集 disclosure naming ニプロ株式会社

ニプロ株式会社 (Pharmaceutical Affairs Act)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Pharmaceutical Affairs ActMinistry of Health, Labour and WelfareGovernment disclosure5 October 2017

Action type

先駆け審査指定制度対象品目の募集

Law

Pharmaceutical Affairs Act

Authority

Ministry of Health, Labour and Welfare

Action date

5 October 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-NIPURO-2017-202608041642
Generated at: 5 August 2026 at 01:42
Record URL: https://regbase.jp/en/enforcement/other-nipuro-20171005

1. Review Summary

Disclosure name	ニプロ株式会社	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	5 October 2017	Authority	Ministry of Health, Labour and Welfare
Law	Pharmaceutical Affairs Act	Action type	先駆け審査指定制度対象品目の募集
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	ニプロ株式会社

3. Enforcement Record

Target name in disclosure	ニプロ株式会社
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Pharmaceutical Affairs Act / 先駆け審査指定制度対象品目の募集
Action / announcement date	Action: 5 October 2017 / Announcement: 3 April 2026
English summary	STR01 (Autologous Bone Marrow Mesenchymal Stem Cells) for improvement of neurological symptoms and functional impairments associated with spinal cord injury
Original Japanese text	STR01（自家骨髄間葉系幹細胞）脊髄損傷に伴う神経症候や機能障害の改善
Official source	https://www.mhlw.go.jp/stf/houdou/0000179802.html
Source archive	https://kiroku.today/a/ceb343f564hf0jc8
Extraction / evidence timestamps	Extracted: 25 April 2026 at 08:38 / Evidence checked: 25 April 2026 at 08:38 / Archive captured: 12 July 2026 at 15:35

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 ニプロ株式会社

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 ニプロ株式会社

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E3%83%8B%E3%83%97%E3%83%AD%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: ニプロ株式会社Japanese only
Original: ニプロ株式会社
Governing law: Pharmaceutical Affairs Act
薬事法
Action type: 先駆け審査指定制度対象品目の募集
先駆け審査指定制度対象品目の募集
Action date: 5 October 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

STR01 (Autologous Bone Marrow Mesenchymal Stem Cells) for improvement of neurological symptoms and functional impairments associated with spinal cord injury

Show original Japanese text

STR01（自家骨髄間葉系幹細胞）脊髄損傷に伴う神経症候や機能障害の改善

Compliance context

Context needed

This 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

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-24T23:38:30.309+00:00
Evidence checked: 2026-04-24T23:38:30.309+00:00
Archive captured: 2026-07-12T06:35:06.810541+00:00

Show audit JSON

{
  "record": {
    "id": "9c446986-a668-4f10-968d-37844dec80c8",
    "url": "https://regbase.jp/en/enforcement/other-nipuro-20171005",
    "company_name_original": "ニプロ株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "action_type": {
      "ja": "先駆け審査指定制度対象品目の募集",
      "en": "先駆け審査指定制度対象品目の募集"
    },
    "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 (ニプロ株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "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-nipuro-20171005",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/ceb343f564hf0jc8",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "archiveCapturedAt": "2026-07-12T06:35:06.810541+00:00",
    "extractedAt": "2026-04-24T23:38:30.309+00:00",
    "translatedAt": "2026-05-01T06:52:22.984+00:00",
    "evidenceCheckedAt": "2026-04-24T23:38:30.309+00:00",
    "generatedAt": "2026-08-04T16:42:26.136Z"
  },
  "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.