Enforcement record

Administrative Guidance disclosure naming フィリピン共和国食品医薬品局(FDA PH)

フィリピン共和国食品医薬品局(FDA PH) (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 disclosure30 June 2022

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

30 June 2022

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

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Preserved evidence by Kiroku

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Open preserved source and evidence pack
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Action summary

Company
フィリピン共和国食品医薬品局(FDA PH)Japanese only
Original: フィリピン共和国食品医薬品局(FDA PH)
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
30 June 2022
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
医薬品規制

Violation

Machine-translated summary — verify against original

On June 30, 2022, the Philippine Food and Drug Administration (FDA PH) engaged in activities aimed at harmonizing regulations to facilitate quicker access to medicines developed in Japan and to reduce review times. This action was taken under the authority of the Ministry of Health, Japan, and pertains to pharmaceutical regulation.

Show original Japanese text

フィリピンにおいて、日本で開発された医薬品へのアクセスを迅速化し、審査期間を短縮するための規制調和活動を行った

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
2026-05-05T00:01:26.474+00:00
Evidence checked
2026-05-05T00:01:26.474+00:00
Archive captured
2026-05-05T00:01:32.446107+00:00
Show audit JSON
{
  "record": {
    "id": "6d4749a8-d321-4537-bdfe-7cd0ccc354e3",
    "url": "https://regbase.jp/en/enforcement/yakkiho-huiripingong-he-guo-shi-pin-yi-yao-pin-jufdaph-20220630",
    "company_name_original": "フィリピン共和国食品医薬品局(FDA PH)",
    "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": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "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-huiripingong-he-guo-shi-pin-yi-yao-pin-jufdaph-20220630",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_26556.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/7d3eda4cc8rv588w",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_26556.html",
    "archiveCapturedAt": "2026-05-05T00:01:32.446107+00:00",
    "extractedAt": "2026-05-05T00:01:26.474+00:00",
    "translatedAt": "2026-07-06T07:42:01.482+00:00",
    "evidenceCheckedAt": "2026-05-05T00:01:26.474+00:00",
    "generatedAt": "2026-08-18T22:09:55.112Z"
  },
  "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.