Enforcement record

Administrative Guidance disclosure naming サノフィ株式会社

サノフィ株式会社 (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 disclosure21 April 2017

Action type

Administrative Guidance

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

21 April 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-SANOHUI-2-202608041527
Generated at: 5 August 2026 at 00:27
Record URL: https://regbase.jp/en/enforcement/yakkiho-sanohui-20170421

1. Review Summary

Disclosure name	サノフィ株式会社	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	21 April 2017	Authority	Ministry of Health, Labour and Welfare
Law	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	Action type	Administrative Guidance
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	サノフィ株式会社

3. Enforcement Record

Target name in disclosure	サノフィ株式会社
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 / Administrative Guidance
Action / announcement date	Action: 21 April 2017 / Announcement: 1 April 2026
English summary	Designated as an item subject to the 'Pioneering Review Designation System'.
Original Japanese text	「先駆け審査指定制度」の対象品目として指定しました
Official source	https://www.mhlw.go.jp/stf/houdou/0000162665.html
Source archive	https://kiroku.today/a/27f0c6af56hf0ind
Extraction / evidence timestamps	Extracted: 25 April 2026 at 08:37 / Evidence checked: 25 April 2026 at 08:37 / Archive captured: 12 July 2026 at 15:34

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 サノフィ株式会社

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 サノフィ株式会社

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%82%B5%E3%83%8E%E3%83%95%E3%82%A3%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: サノフィ株式会社Japanese only
Original: サノフィ株式会社
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Administrative Guidance
行政指導
Action date: 21 April 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

Designated as an item subject to the 'Pioneering Review Designation System'.

Show original Japanese text

「先駆け審査指定制度」の対象品目として指定しました

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

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

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 source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-24T23:37:10.501+00:00
Evidence checked: 2026-04-24T23:37:10.501+00:00
Archive captured: 2026-07-12T06:34:06.420845+00:00

Show audit JSON

{
  "record": {
    "id": "5c605eeb-5c81-42cd-999a-a83b9f3a061d",
    "url": "https://regbase.jp/en/enforcement/yakkiho-sanohui-20170421",
    "company_name_original": "サノフィ株式会社",
    "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": "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 (サノフィ株式会社). 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": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-sanohui-20170421",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000162665.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/27f0c6af56hf0ind",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000162665.html",
    "archiveCapturedAt": "2026-07-12T06:34:06.420845+00:00",
    "extractedAt": "2026-04-24T23:37:10.501+00:00",
    "translatedAt": "2026-05-01T06:51:31.885+00:00",
    "evidenceCheckedAt": "2026-04-24T23:37:10.501+00:00",
    "generatedAt": "2026-08-04T15:27:18.160Z"
  },
  "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.