# 医療法 / Medical Care Act — 第三十七条 (Article 37)

- Law: 医療法 (Medical Care Act), 昭和二十三年法律第二百五号
- English title "Medical Care Act": Ministry of Justice translation
- Kind: Act — the distinction between 法律 (Act), 政令 (Cabinet Order), 省令 (Ministerial Order) and 条例 (local ordinance) decides who may issue it and what it may say.
- Provision: 第三十七条 (Article 37) — address `art-37`
- Text in force since: 2026-10-01
- URL (the page that opens at this provision): https://japanlaw.org/en/medical-care-act/art-37
- Permanent URL (e-Gov law ID, never renamed): https://japanlaw.org/l/323AC0000000205/art-37
- Every provision below carries its address and both URLs on the line under it.
- Japanese text: e-Gov 法令検索, Digital Agency (デジタル庁). English: as marked on each line below.

Only the Japanese as published by the government has legal effect; the text
below is a copy of it. Every English rendering below is a translation and
says which kind: the Ministry of Justice's translation, or this
site's machine translation, whose model and date the Sources list names.
They are never merged and never substituted for one another.

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### 第三十七条
<sup>art-37 · https://japanlaw.org/en/medical-care-act/art-37 · https://japanlaw.org/l/323AC0000000205/art-37</sup>

  **第一項**  厚生労働大臣は、供給確保医薬品及びその製造に必要不可欠であると認められる原料又は材料（以下「供給確保医薬品等」という。）の安定的な供給の確保を図るための指針（以下「安定供給確保指針」という。）を定めるものとする。
  <sup>art-37/par-1 · https://japanlaw.org/en/medical-care-act/art-37/par-1 · https://japanlaw.org/l/323AC0000000205/art-37/par-1</sup>
  The Minister of Health, Labour and Welfare is to establish guidelines for securing the stable supply of supply security pharmaceuticals and the raw materials or materials recognized as indispensable for their manufacture (hereinafter referred to as "supply security pharmaceuticals, etc.") (hereinafter referred to as the "guidelines for securing stable supply").
  <sup>machine translation, not official</sup>

  **第二項**  安定供給確保指針においては、次に掲げる事項を定めるものとする。
  <sup>art-37/par-2 · https://japanlaw.org/en/medical-care-act/art-37/par-2 · https://japanlaw.org/l/323AC0000000205/art-37/par-2</sup>
  The guidelines for securing stable supply are to prescribe the following particulars:
  <sup>machine translation, not official</sup>

    **一**  供給確保医薬品等の安定的な供給の確保に関する基本的な方向
    <sup>art-37/par-2/item-1 · https://japanlaw.org/en/medical-care-act/art-37/par-2/item-1 · https://japanlaw.org/l/323AC0000000205/art-37/par-2/item-1</sup>
    the basic direction concerning securing the stable supply of supply security pharmaceuticals, etc.;
    <sup>machine translation, not official</sup>

    **二**  供給確保医薬品等の供給不足の発生を未然に防止するための施策に関する事項
    <sup>art-37/par-2/item-2 · https://japanlaw.org/en/medical-care-act/art-37/par-2/item-2 · https://japanlaw.org/l/323AC0000000205/art-37/par-2/item-2</sup>
    particulars concerning measures to prevent the occurrence of supply shortages of supply security pharmaceuticals, etc.;
    <sup>machine translation, not official</sup>

    **三**  供給確保医薬品等の供給不足が発生した場合における製造又は輸入に関する事項
    <sup>art-37/par-2/item-3 · https://japanlaw.org/en/medical-care-act/art-37/par-2/item-3 · https://japanlaw.org/l/323AC0000000205/art-37/par-2/item-3</sup>
    particulars concerning manufacture or importation in the case where a supply shortage of supply security pharmaceuticals, etc. occurs; and
    <sup>machine translation, not official</sup>

    **四**  その他供給確保医薬品等の安定的な供給の確保に関する重要事項
    <sup>art-37/par-2/item-4 · https://japanlaw.org/en/medical-care-act/art-37/par-2/item-4 · https://japanlaw.org/l/323AC0000000205/art-37/par-2/item-4</sup>
    other important particulars concerning securing the stable supply of supply security pharmaceuticals, etc.
    <sup>machine translation, not official</sup>

  **第三項**  厚生労働大臣は、安定供給確保指針を定め、又はこれを変更したときは、遅滞なく、これを公表するものとする。
  <sup>art-37/par-3 · https://japanlaw.org/en/medical-care-act/art-37/par-3 · https://japanlaw.org/l/323AC0000000205/art-37/par-3</sup>
  When the Minister of Health, Labour and Welfare has established or amended the guidelines for securing stable supply, the Minister is to publish them without delay.
  <sup>machine translation, not official</sup>

  **第四項**  第一項の「供給確保医薬品」とは、特定医薬品であつて、次に掲げる事項を勘案し、その安定的な供給の確保を図る必要性が高いものとして、厚生労働大臣が厚生科学審議会の意見を聴いて指定するものをいう。
  <sup>art-37/par-4 · https://japanlaw.org/en/medical-care-act/art-37/par-4 · https://japanlaw.org/l/323AC0000000205/art-37/par-4</sup>
  "Supply security pharmaceutical" in paragraph (1) means a specified pharmaceutical that the Minister of Health, Labour and Welfare, after hearing the Health Sciences Council, designates as having a high necessity of securing its stable supply, in consideration of the following particulars:
  <sup>machine translation, not official</sup>

    **一**  その用途に係る疾病にかかつた場合の病状の程度
    <sup>art-37/par-4/item-1 · https://japanlaw.org/en/medical-care-act/art-37/par-4/item-1 · https://japanlaw.org/l/323AC0000000205/art-37/par-4/item-1</sup>
    the degree of severity of the symptoms in the case of contracting the disease for which it is used;
    <sup>machine translation, not official</sup>

    **二**  当該特定医薬品と代替性のある特定医薬品又は治療方法の有無
    <sup>art-37/par-4/item-2 · https://japanlaw.org/en/medical-care-act/art-37/par-4/item-2 · https://japanlaw.org/l/323AC0000000205/art-37/par-4/item-2</sup>
    the existence or non-existence of a specified pharmaceutical or treatment method that can substitute for the specified pharmaceutical;
    <sup>machine translation, not official</sup>

    **三**  その製造に要する特別の技術の有無、原料又は材料の供給事情その他の製造又は供給に関して留意すべき事項
    <sup>art-37/par-4/item-3 · https://japanlaw.org/en/medical-care-act/art-37/par-4/item-3 · https://japanlaw.org/l/323AC0000000205/art-37/par-4/item-3</sup>
    the existence or non-existence of special technology required for its manufacture, the supply situation of raw materials or materials, and other particulars to be noted regarding its manufacture or supply; and
    <sup>machine translation, not official</sup>

    **四**  その他厚生労働省令で定める事項
    <sup>art-37/par-4/item-4 · https://japanlaw.org/en/medical-care-act/art-37/par-4/item-4 · https://japanlaw.org/l/323AC0000000205/art-37/par-4/item-4</sup>
    other particulars specified by an Order of the Ministry of Health, Labour and Welfare.
    <sup>machine translation, not official</sup>

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## Cites
- art-37/par-4: 第一項 → 医療法 第三十七条第一項 (Article 37, paragraph (1)), art-37/par-1 — https://japanlaw.org/en/medical-care-act/art-37/par-1 · https://japanlaw.org/l/323AC0000000205/art-37/par-1

## Cited by

3 provisions cite this one. No official source publishes this direction.

- 医療法 第三十七条第四項 — https://japanlaw.org/en/medical-care-act/art-37/par-4 · https://japanlaw.org/l/323AC0000000205/art-37/par-4
- 医療法 第三十八条第一項 — https://japanlaw.org/en/medical-care-act/art-38/par-1 · https://japanlaw.org/l/323AC0000000205/art-38/par-1
- 医療法 附則第十三条第十一項（施行前の準備） — https://japanlaw.org/en/medical-care-act/suppl-5071-37/art-13/par-11 · https://japanlaw.org/l/323AC0000000205/suppl-5071-37/art-13/par-11

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## Sources

- e-Gov 法令検索, Digital Agency (デジタル庁) — 医療法 — the text in force from 2026-10-01 (https://laws.e-gov.go.jp/law/323AC0000000205/20261001_507AC0000000087), retrieved 2026-10-19
- Japanese Law Translation Database System, Ministry of Justice (法務省) — Medical Care Act — Ministry of Justice translation (https://www.japaneselawtranslation.go.jp/en/laws/view/4006/tb), retrieved 2026-10-19
- claude-sonnet-5-5 — Machine translation, batch medical-care-act-20261019T151250-006, translated 2026-10-20
- claude-sonnet-5-5 — Machine translation, batch medical-care-act-20261019T151250-007, translated 2026-10-20
- This site's parser, version 210 — 医療法 — structure, counts, cross-references and defined terms, computed 2026-10-19