Enforcement record

先駆け審査指定制度対象品目の募集 disclosure naming 小野薬品工業株式会社

小野薬品工業株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

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

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry 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

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

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-YAKKIHO-XIAO-YE-Y-202608041530
Generated at: 5 August 2026 at 00:30
Record URL: https://regbase.jp/en/enforcement/yakkiho-xiao-ye-yao-pin-gong-ye-20171005

1. Review Summary

Disclosure name	小野薬品工業株式会社	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	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	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	小野薬品工業株式会社

3. Enforcement Record

Target name in disclosure	小野薬品工業株式会社
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / 先駆け審査指定制度対象品目の募集
Action / announcement date	Action: 5 October 2017 / Announcement: 27 April 2026
English summary	The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, aiming for early practical application in Japan.
Original Japanese text	厚生労働省は、革新的医薬品・医療機器・再生医療等製品を日本で早期に実用化することを目的として、その開発を促進するために、平成27年４月１日に「先駆け審査指定制度」を創設しました。
Official source	https://www.mhlw.go.jp/stf/houdou/0000179802.html
Source archive	https://kiroku.today/a/ceb343f564hi8gdl
Extraction / evidence timestamps	Extracted: 28 April 2026 at 03:02 / Evidence checked: 28 April 2026 at 03:02 / Archive captured: 28 April 2026 at 03:03

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 小野薬品工業株式会社

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 小野薬品工業株式会社

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

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/api/v1/enforcements?company=%E5%B0%8F%E9%87%8E%E8%96%AC%E5%93%81%E5%B7%A5%E6%A5%AD%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: 小野薬品工業株式会社Japanese only
Original: 小野薬品工業株式会社
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
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
Industry context: 医薬品

Violation

Machine-translated summary — verify against original

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, aiming for early practical application in Japan.

Show original Japanese text

厚生労働省は、革新的医薬品・医療機器・再生医療等製品を日本で早期に実用化することを目的として、その開発を促進するために、平成27年４月１日に「先駆け審査指定制度」を創設しました。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

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: 2026-04-27T18:02:31.308+00:00
Evidence checked: 2026-04-27T18:02:31.308+00:00
Archive captured: 2026-04-27T18:03:15.938947+00:00

Show audit JSON

{
  "record": {
    "id": "df96ae0a-9bd7-4e2f-9c0d-235dc16b1c7b",
    "url": "https://regbase.jp/en/enforcement/yakkiho-xiao-ye-yao-pin-gong-ye-20171005",
    "company_name_original": "小野薬品工業株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "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 (小野薬品工業株式会社). 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": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-xiao-ye-yao-pin-gong-ye-20171005",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/ceb343f564hi8gdl",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "archiveCapturedAt": "2026-04-27T18:03:15.938947+00:00",
    "extractedAt": "2026-04-27T18:02:31.308+00:00",
    "translatedAt": "2026-05-01T09:43:33.726+00:00",
    "evidenceCheckedAt": "2026-04-27T18:02:31.308+00:00",
    "generatedAt": "2026-08-04T15:30:25.418Z"
  },
  "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.