RegBase evidence report
Saveable record of the target entity, regulator disclosure, source status, and review notes for internal compliance files.
| Target entity | 医薬・生活衛生局 | Corporate Number | Not recorded |
|---|---|---|---|
| Enforcement record | 1 record | Other records for this company | 1 records |
| Action date | 27 August 2021 | 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 | Original-source archive or viewer URL 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.
| English display name | 医薬・生活衛生局 |
|---|---|
| Original Japanese name | 医薬・生活衛生局 |
| English-name source | Japanese original |
| Corporate Number | Not recorded |
| Company status | Active |
| Representative | Not recorded |
| Registered address | Not recorded |
| Industry / capital | Industry: Not recorded / Capital: - |
| Target name in disclosure | 医薬・生活衛生局 |
|---|---|
| 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: 27 August 2021 / Announcement: 10 April 2026 |
| English summary | Explanation of the holding of regular opinion exchange meetings regarding approval reviews and safety measures for medical devices and in vitro diagnostics, and efforts toward system improvements and enhancements. |
| Original Japanese text | 医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会の開催と、制度の改良・改善に向けた取組についての説明。 |
| Official source | https://www.mhlw.go.jp/stf/newpage_21919.html |
| Source archive | https://kiroku.today/a/2077ea6711ijow9q |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:20 / Evidence checked: 25 April 2026 at 09:20 / Archive captured: 10 April 2026 at 09:00 |
No additional structured business-location or permit fields are recorded for this disclosure.
| Company | 医薬・生活衛生局 |
|---|---|
| Law | 薬事規制に関する守秘取り決め |
| Summary | Entered into a confidentiality agreement with the United States Pharmacopeia regarding drug regulation to strengthen cooperation. |
| RegBase URL | https://regbase.jp/en/enforcement/other-yi-yao-sheng-huo-wei-sheng-ju-20170620 |
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
Evidence report
Includes target-entity identifiers, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.
You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.
Explanation of the holding of regular opinion exchange meetings regarding approval reviews and safety measures for medical devices and in vitro diagnostics, and efforts toward system improvements and enhancements.
医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会の開催と、制度の改良・改善に向けた取組についての説明。
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.
{
"record": {
"id": "6befaf78-8645-4eef-a963-3ecf3b182567",
"url": "https://regbase.jp/en/enforcement/yakkiho-yi-yao-sheng-huo-wei-sheng-ju-20210827",
"company_name_original": "医薬・生活衛生局",
"company_name_registry": "医薬・生活衛生局",
"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": "possible",
"confidence": 60,
"method": "extracted_japanese_name",
"method_label": "Company name extracted from the Japanese public disclosure",
"notes": null
},
"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-yi-yao-sheng-huo-wei-sheng-ju-20210827",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
"archiveUrl": "https://kiroku.today/view/2077ea6711ijow9q",
"archiveCapturedAt": "2026-04-10T00:00:45.913+00:00",
"extractedAt": "2026-04-25T00:20:37.241+00:00",
"translatedAt": "2026-05-01T07:08:50.142+00:00",
"evidenceCheckedAt": "2026-04-25T00:20:37.241+00:00",
"generatedAt": "2026-07-06T04:38:43.186Z"
},
"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.
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.