Global texts are different from regional law
Regional regulations (see the regional guide) are written by governments and are usually free to reuse. Global texts are written by international bodies, and their terms range from open to strictly licensed. Two facts make this the riskiest part of any regulatory AI knowledge base:
- Regions build global texts into law. The US QMSR incorporates ISO 13485:2016 by reference. Japan’s QMS Ordinance is aligned with ISO 13485. FDA, EMA, and PMDA implement ICH guidelines. So teams need these texts constantly.
- Being referenced in law does not make a standard free. ISO and IEC keep copyright and now expressly restrict AI use.
The five global sources at a glance
| Source | Who writes it | 2026 status to know | Terms for AI use | Our rating |
|---|---|---|---|---|
| ICH Q7, Q8, Q9, Q10, Q12 | ICH (regulators and industry) | Q9(R1) Step 4 January 2023; new consolidated Q1 targeted for Step 4 November 2026 | Use, reproduce, and adapt allowed with ICH copyright acknowledged and changes labeled; logo and third-party content excluded | Check required |
| IMDRF documents | Medical device regulators | 2026 implementation report published 1 September 2026 | Personal, research, educational, or internal use only, no commercial purpose; other use needs permission | Check required |
| PIC/S PE 009 | GMP inspectorates | PE 009-18 in force 24 September 2026 (revised Annex 19) | Terms not stated on the pages we opened; check the PDF or ask PIC/S | Check required |
| ISO 13485, ISO 14971 | ISO | ISO 13485:2016 now part of US QMSR (from 2 February 2026) | AI and ML use prohibited without a separate licence, including prompting and querying; TDM exception opted out | Permission required |
| IEC 62304, IEC 60601 | IEC | IEC 62304 edition 2 now expected 26 October 2028 | No use in public or private AI tools, no scraping, without IEC’s express permission | Permission required |
From open to licensed: a simple scale
| Level | Sources | What you can usually do |
|---|---|---|
| Open with conditions | ICH | Index full text, quote, and summarize, keeping the copyright line and labeling changes |
| Internal use only | IMDRF | Use inside your organization; ask before commercial or customer-facing use |
| Unclear: confirm first | PIC/S | Confirm terms before full-text indexing; regional EU texts may be an alternative |
| Licensed: no AI without permission | ISO, IEC | Keep text out of AI tools; reference clause numbers; analyze your own documents |
How regions adopt global texts
| Global text | US | EU | Japan |
|---|---|---|---|
| ICH quality guidelines | FDA guidance | EMA scientific guidelines, EU GMP Part III | PMDA/MHLW notifications |
| ISO 13485 | Incorporated by reference in QMSR (21 CFR 820) | Harmonised standard under MDR/IVDR | QMS Ordinance aligned with ISO 13485:2016 |
| PIC/S GMP guide | Compare with 21 CFR 210 and 211 | Closely aligned with EU GMP guide | Compare with the GMP Ordinance |
| IMDRF documents | Check status in the IMDRF 2026 implementation report | Check status in the same report | Check status in the same report |
A practical rule follows: when the global text is restricted, use the regional adoption instead. The regional text is usually openly reusable and is what inspectors actually enforce.
Building the global layer of a knowledge base
- Classify each source by licence level using the scale above, and store the licence text with the file.
- Remove ISO and IEC full text from any AI index unless you hold an AI-permitted licence in writing.
- Keep ICH copyright lines in metadata and outputs, and label summaries as adapted.
- Separate internal and external use for IMDRF documents.
- Record step, edition, and version (ICH Step 4 date, ISO edition, PIC/S PE number).
- Watch known dates: ICH Q1 Step 4 (target November 2026), EU GMP Annex 11 and Annex 22 final texts (target Q4 2026), IEC 62304 edition 2 (October 2028).
Common mistakes
- Assuming “incorporated by reference” makes ISO 13485 public.
- Thinking a private or on-premises AI model avoids ISO or IEC restrictions. Both cover private tools.
- Treating IMDRF’s free download as permission for commercial AI use.
- Losing ICH’s copyright notice during chunking.
- Indexing an outdated PIC/S version after 24 September 2026.
How AskDona helps
AskDona analyzes your own quality documents and maps them to clause numbers and to the openly reusable regional texts that adopt global standards. You get evidence-backed gap findings without loading licensed ISO or IEC text, unless your licence allows it.
Run a sample global-to-regional mapping check
AskDona shows the evidence; your quality team decides.
Editor’s note. This article is general information, not legal advice. Status and licence notes summarize the detailed articles linked above, each checked against official or primary pages by October 26, 2026. Our ratings are first-pass judgments, not legal opinions. Confirm licence terms with each body before use.
FAQ
Which global standards can I put into an AI tool? ICH guidelines, with copyright acknowledged and changes labeled. IMDRF documents for internal use. ISO and IEC only with an AI-permitted licence.
Does buying ISO 13485 let me use it in RAG? No. ISO’s licence prohibits AI and ML use, including prompting and querying, without a separate licence.
What if I need ISO content in my AI workflow? Ask ISO or your national standards body for an AI-permitted licence, or reference clause numbers and use regional texts.
Are global guidelines binding? Not by themselves. They become binding or expected when a regulator adopts them.
References
All pages opened and checked by October 26, 2026. Each linked article lists its own primary sources.
| Source | What it supports |
|---|---|
| ICH Q9(R1) Step 4 guideline (PDF) | ICH copyright terms; Step 4 date |
| ICH Q1 work plan, March 2026 (PDF) | Q1 Step 4 target |
| IMDRF Document Implementation Report 2026 (PDF) | IMDRF terms; implementation report |
| PIC/S: PE 009-17 and PE 009-18 news | PE 009-18 in force 24 Sep 2026 |
| ISO: Licence agreement | AI and ML prohibition; TDM opt-out |
| IEC Webstore: Terms and conditions | AI and scraping restrictions |
| QuickBird Medical: IEC 62304 edition 2 delayed | New expected date |
| FDA: QMSR | ISO 13485 incorporated by reference |
| European Commission: EudraLex Volume 4 | EU GMP Part III and annex status |