Why a regional map matters for AI
A company selling medical devices or medicines in Japan, the US, and the EU works under three legal systems. Each one mixes binding law, nonbinding guidance, and public databases, and each sets its own reuse terms. When these sources go into one AI knowledge base, three problems appear quickly:
- Binding and nonbinding text get blended. Guidance starts to sound like law.
- Versions drift. Several sources changed in 2025 and 2026, and old text keeps answering questions.
- Reuse terms differ. Some sources are public domain, some need attribution, and some databases need checking before any automated use.
The tables below summarize each region. Each row links to a detailed article.
Japan
| Source | Type | 2026 status to know | Reuse and AI caution |
|---|---|---|---|
| PMD Act (薬機法) | Law | 2025 amendment (Act No. 37) takes effect in stages through 2028 | Government text; translations are unofficial |
| GMP, GQP, GVP ordinances | Ministerial ordinances | Track amendments tied to the PMD Act revision | Use Japanese original as the authority |
| QMS Ordinance (MO169) | Ministerial ordinance | Aligned with ISO 13485:2016; compliance required from March 2024 | ISO text itself is licensed separately |
| Japanese Pharmacopoeia | Official compendium | JP19 notified April 2026; errata June and September 2026; no English version yet | Track errata and supplements |
| PMDA guidelines | Guidance and notices | Many English translations are reference only | PDL1.0 applies; crawling and bulk download prohibited |
| Package inserts and RMPs | Product information | Updated by marketing authorization holders | Copyright of the MAH, not PMDA; permission likely needed |
| e-Gov Law Search | Official law database | API v2 since March 2025, with point-in-time search | Follow e-Gov terms; record the point-in-time date |
Japan in one line: good official access, but English versions are not authoritative, and PMDA bars crawling.
United States
| Source | Type | 2026 status to know | Reuse and AI caution |
|---|---|---|---|
| eCFR: 21 CFR Parts 11, 210, 211, 820 | Regulation | QMSR (Part 820) effective 2 February 2026, incorporating ISO 13485:2016 | eCFR is not the official legal edition; ISO text not included |
| FDA guidance documents | Nonbinding guidance | Part 11 clinical investigations Q&A finalized October 2024 | Public domain unless noted; tag draft vs final |
| Form 483 observations | Inspection data | Annual spreadsheets FY2006–FY2025 | Summaries are reusable; individual 483s need privacy review |
| Warning letters | Enforcement correspondence | Posted with a disclaimer that matters may have changed | Reusable, but frame as “FDA alleged” with dates |
US in one line: the most open region for reuse; the risk is mostly accuracy (draft vs final, observation vs violation, old Part 820).
European Union
| Source | Type | 2026 status to know | Reuse and AI caution |
|---|---|---|---|
| MDR 2017/745 | Regulation | Legacy deadlines end 2027/2028; simplification proposal (Dec 2025) not yet law | Attribution; only the Official Journal is authentic |
| IVDR 2017/746 | Regulation | Class D 2027, C 2028, B and A sterile 2029 | Track CELEX and consolidation dates |
| CTR 536/2014 | Regulation | Transition completed 31 January 2025 | Cite the OJ original |
| EU GMP Annexes 1, 11, 15 | Guidelines | Annex 11, Chapter 4, and new Annex 22 (AI) drafts; final texts targeted Q4 2026 | CC BY 4.0; keep drafts separate |
| EudraLex | Law and guidelines collection | Veterinary GMP left Volume 4 on 15 July 2026 | CC BY 4.0; tag law vs guideline |
| EMA guidelines | Nonbinding guidance | EMA/FDA AI principles published January 2026 | Reuse allowed with EMA acknowledged in each copy |
| MDCG guidance | Nonbinding guidance | Many 2026 updates on EUDAMED, UDI, IVD classification | CC BY 4.0; store separately from the regulations |
| EUDAMED | Database | Four modules mandatory since 28 May 2026 | Operator and personal data; check terms first |
| EudraGMDP | Database | Public version since 2011 | No bulk terms stated; query, don’t harvest |
EU in one line: generous licences for Commission and EMA text, but many moving dates and a clear line between authentic and consolidated texts.
Comparing the three regions
| Question | Japan | US | EU |
|---|---|---|---|
| Default reuse terms for official text | PDL1.0 (CC BY 4.0 compatible), with exceptions | Public domain unless noted | CC BY 4.0 (Commission) or acknowledgement (EMA) |
| Authoritative version | Japanese original | Official CFR edition and Federal Register | Official Journal |
| Biggest 2026 change | Staged PMD Act amendment; JP19 | QMSR in force | EUDAMED mandatory modules; MDR/IVDR deadlines approaching |
| Main AI risk | Treating English translations as authoritative; crawling PMDA | Mixing draft and final; old Part 820 text | Treating proposals or drafts as law |
| Databases needing care | Package inserts (MAH copyright) | Individual 483s | EUDAMED, EudraGMDP |
Building one knowledge base across regions
- Add a jurisdiction field (JP, US, EU) to every document, and never let an answer cite one region for another.
- Add a layer field: law, guidance, database, or proposal/draft.
- Record version and date for every file: consolidation date, notification number, fiscal year, or “as of” date.
- Record reuse terms per source, including attribution text, and attach it to outputs automatically.
- Exclude licensed standards (ISO, IEC) unless you hold an AI-permitted licence. See the global standards guide.
- Set a refresh calendar. Known dates for late 2026 and 2027 include EU GMP final texts (target Q4 2026), MDR class III legacy deadline (end 2027), and IVDR class D deadline (end 2027).
How AskDona helps
AskDona checks your documents against the regional sources you choose and keeps jurisdiction, layer, and version visible on every finding. A single SOP can be compared with FDA, PMDA, and EU expectations side by side, with each requirement cited to its own source.
Run a sample three-region gap check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. Status and reuse notes summarize the detailed articles linked above, each checked against official or primary pages by October 26, 2026. Our ratings in each article are first-pass judgments, not legal opinions.
FAQ
Which region is easiest to use in AI tools? The US, because FDA content is generally public domain. The main work is version and status tagging.
Can I rely on English translations of Japanese law? Use them for understanding, but cite the Japanese original as the authority.
Are EU proposals and drafts safe to index? Yes, if stored separately and labeled as not in force.
What should I not put in a regional knowledge base? Licensed standards without permission, bulk-harvested database content, and personal data from inspection or registration records.
References
All pages opened and checked by October 26, 2026. Each linked article lists its own primary sources.
| Source | What it supports |
|---|---|
| FDA: QMSR | QMSR effective 2 February 2026 |
| FDA Website Policies | Public domain unless noted |
| eCFR: Getting Started | eCFR not an official legal edition |
| EUR-Lex legal notice | OJ authenticity, reuse policy |
| European Commission legal notice | CC BY 4.0 |
| EMA legal notice | Reproduction with acknowledgement |
| European Commission: EUDAMED overview | Mandatory modules from 28 May 2026 |
| HPRA: IVDR transitional provisions | IVDR deadlines by class |
| Regulation (EU) 2023/607 | MDR legacy deadlines |
| European Commission: EudraLex Volume 4 | Annex status |