Why US companies need to read Japanese law, not summaries
Japan’s core law for drugs, medical devices and regenerative medical products is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), usually called the PMD Act (Yakkiho in Japanese). Around it sits a stack of cabinet orders, Ministry of Health, Labour and Welfare (MHLW) ordinances, public notices and administrative notifications. For a US company entering Japan, the details that decide approval and inspection outcomes are usually in that lower stack, not in the Act itself.
How the layers fit together
| Layer | Japanese term | What it does | Example |
|---|---|---|---|
| Act | 法律 (horitsu) | Sets licensing, approval, safety and penalty framework | PMD Act |
| Cabinet order | 政令 (seirei) | Details delegated by the Act | Enforcement Order of the PMD Act |
| Ministerial ordinance | 省令 (shorei) | Binding technical requirements | GMP ordinance, QMS ordinance (MO169) |
| Public notice | 告示 (kokuji) | Standards and lists | Japanese Pharmacopoeia, device classifications |
| Notification | 通知 (tsuchi) | Interpretation and procedures issued by MHLW bureaus | Application procedures, Q&As |
Notifications are not laws, but regulators and inspectors rely on them, and they often carry the practical detail a US team needs.
What changed recently: the 2025 amendment
The PMD Act was amended by Act No. 37 of 2025, enacted on May 14, 2025, following a five-year review of the 2019 amendments (Nishimura & Asahi). The changes take effect in stages:
| Effective | Selected changes |
|---|---|
| November 20, 2025 | Supply monitoring using e-prescription data; funds for generic drug industry restructuring and drug-discovery manufacturing |
| May 1, 2026 | Revised conditional approval (Phase III difficulty requirement removed, revocation added); priority review for overseas alternative drugs during shortages; rules for abuse-prone OTC drugs; online OTC counseling |
| By May 2027 | Quality Assurance Managers and Safety Control Managers become legal requirements; supply-control managers and shortage reporting |
| By May 2028 | New medium-risk change category with a three-month decision; annual reporting for specific minor changes |
For foreign manufacturers and Japanese marketing authorization holders, the 2027 governance changes and the 2028 change-management categories are the ones that will alter procedures.
Where to find the texts
- MHLW law and notification database (mhlw.go.jp/hourei): ordinances, notices and notifications in Japanese.
- e-Gov Law Search (laws.e-gov.go.jp): the official consolidated text of the Act and ordinances, with past versions.
- Japanese Law Translation (japaneselawtranslation.go.jp): an English translation of the PMD Act. The version shown is based on Act No. 50 of 2015, so it predates the 2019 and 2025 amendments (Japanese Law Translation).
- PMDA English pages: tentative translations of selected ordinances, such as the QMS ordinance (PMDA).
English translations are useful for orientation but can be years out of date. Treat the Japanese text as authoritative.
Reuse terms: PDL1.0
MHLW website content belongs to MHLW unless stated otherwise and, where no other rights notice appears, may be used under the Public Data License 1.0 (PDL1.0) (MHLW copyright policy). The Digital Agency’s summary of PDL1.0 says content may be copied, transmitted, translated and modified, that “commercial use … is also permitted”, and that the license is compatible with CC BY 4.0 (Digital Agency).
Conditions that matter in practice:
- Cite the source, for example “Source: MHLW website (page URL)”.
- Label edits. Translated, summarized or restructured content must say it was edited and by whom, and must not look like an official government publication.
- Exclusions. Logos and symbols are excluded, as is content marked with other terms. Third-party material inside a document (for example, an industry association’s template) may need separate permission.
Using these texts in AI and RAG systems
Our first-pass rating for this source is conditional use: collection and use can be considered once conditions are checked. A practical approach:
- Keep metadata. Store the issuing bureau, document number, issue date, effective date and amendment history with each chunk.
- Separate layers. Tag Act, ordinance, notice and notification text differently so answers do not treat a Q&A as law.
- Track versions. Keep superseded notifications and mark them as such; many requests are about what applied at a past date.
- Record attribution. Generate source citations and an “edited by” statement for any translated or summarized output.
- Screen exceptions. Check each document for a separate rights notice or third-party content before ingestion.
Common mistakes
- Relying on a 2015-era English translation for current requirements.
- Treating notifications as optional because they are not laws.
- Missing staged effective dates in the 2025 amendment.
- Publishing machine-translated summaries without an edit notice.
Checklist
- Identify the Act, ordinance, notice and notifications that apply to your product
- Use the Japanese text as the reference; note the English translation date
- Map 2025 amendment dates to your project plan
- Store document numbers and effective dates in your knowledge base
- Add PDL1.0 attribution and edit notices to derived content
How AskDona helps
US teams entering Japan often have procedures written for FDA and EU rules. AskDona reads your procedures against the Japanese requirements you load, flags gaps and cites both the requirement and your document page. Run a sample Japan regulatory gap check on one procedure. AskDona shows the evidence; your regulatory team decides.
Editor’s note: The licensing summary reflects MHLW and Digital Agency pages read on the date below; it is not legal advice. Our source list labels this row “conditional use” as a first-pass judgment, not a legal opinion. The 2025 amendment summary relies on a law-firm newsletter.
FAQ
What is the PMD Act? Japan’s main law governing drugs, medical devices and regenerative medical products (Act No. 145 of 1960).
When was the PMD Act last amended? Act No. 37 of 2025, enacted May 14, 2025, with staged effective dates through 2028.
Is there an official English version? An English translation exists, but it reflects the Act as of 2015. Use the Japanese text for current requirements.
Can MHLW documents be used commercially? Generally yes under PDL1.0, with attribution and edit notices, except for logos and content under separate terms.
References
All pages opened and checked by October 26, 2026.
| Source | Type | Used for |
|---|---|---|
| MHLW: Copyright policy | Regulator policy | PDL1.0, attribution, exceptions |
| Digital Agency: Public Data License 1.0 | Government license | Permitted uses, CC BY compatibility |
| Nishimura & Asahi: 2025 PMD Act amendments | Law firm newsletter | Amendment contents and dates |
| Japanese Law Translation: PMD Act | Government translation database | English text and version |
| PMDA: QMS ordinance translations | Regulator page | Tentative translations |