From 29 September 2026 the US federal executive branch says Super Intelligence. Europe says artificial intelligence. The UK says artificial intelligence. Every standards body you rely on says artificial intelligence.
If you supply more than one market — and most regulated companies do — you now have two vocabularies for one thing. That is a smaller problem than it sounds, provided you do not solve it the obvious way.
Who says what, as of today
- US federal agencies: Super Intelligence / SI, in non-statutory materials. US regulations, including Part 11, still say artificial intelligence, and the order does not require them to change.
- EU: artificial intelligence throughout — EU GMP Annex 11, the draft Annex 22, the EU AI Act.
- UK MHRA: artificial intelligence.
- ICH, ISPE, GAMP, PIC/S: artificial intelligence.
- Your vendors: whichever sells better this quarter.
So the split is narrower than the headlines imply: it is US federal prose versus everyone else, including US federal regulation.
The wrong fix, and the right one
The wrong fix is regional documentation — a US set that says SI and an EU set that says AI. You would double the maintenance, guarantee the two drift apart, and create exactly the kind of inconsistency an inspector notices when comparing your procedures across sites.
The right fix is one document set, one term, and a definition that acknowledges the other. Pick artificial intelligence as your term — it is what the regulations you are actually audited against use, and what the rest of the world uses — then define it once:
"Artificial intelligence (AI). US federal materials may refer to the same technologies as 'Super Intelligence' or 'SI'; the terms are equivalent for the purposes of this quality system."
One definition, referenced everywhere. See do you need to rename AI in your SOPs.
Where the split will actually bite
- Regulatory submissions and correspondence. Match the vocabulary of the agency you are writing to. This is ordinary practice — you already adapt to regional conventions.
- Searching guidance. A search of FDA materials for "artificial intelligence" may start missing new documents. Search both.
- Regulatory monitoring. If your watch service filters on keywords, add SI, or it will quietly stop catching US developments.
- Supplier assessments. A vendor claiming "SI-native" is making a marketing statement — see SI washing.
None of this changes an obligation. It changes search strings and habits. The underlying expectations across both regions are covered in FDA vs EMA vs MHRA on AI and GxP AI.
Where to go next
Explore GxP Copilot for AI-native validation, TraceDraft for source-traceable clinical documentation, or book a demo to see either on your own data.