FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines
FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines — 50% covered.
4 requirements · 0 enforced · 4 designed · 0 advisory · 0 deferred.
Source: FDA's framework / draft guidance on the use of AI in the development of drug and biological products, and the EMA's reflection paper on the use of AI across the medicinal-product lifecycle, set expectations for AI-derived candidates entering regulated drug / device pipelines: documented provenance of AI-generated designs, reproducibility, model transparency, and GxP data-integrity (ALCOA+) for AI-supported decisions. KYE Protocol™ governs whether an AI-derived candidate may PROCEED to a regulated stage, binding replay-provable provenance and human oversight. KYE does not design candidates, run trials, or determine clinical efficacy. · License: FDA and EMA guidance / reflection-paper documents are published by the agencies; KYE registry cites their AI-provenance and data-integrity expectations for mapping purposes.
By category
| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
|---|---|---|---|---|---|---|
| AI design provenance & reproducibility | 2 | 0 | 2 | 0 | 0 | 50% |
| GxP data integrity (ALCOA+) | 1 | 0 | 1 | 0 | 0 | 50% |
| Human oversight & accountability | 1 | 0 | 1 | 0 | 0 | 50% |
Every requirement → the KYE™ artefact that enforces it
| ID | Title | Status | KYE™ enforcement |
|---|---|---|---|
fda-ema.design-provenance |
AI-derived candidate carries documented design provenance into the pipeline | designed | rule_packs: kye:rule-pack:bio-chem-governancedictionaries: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
fda-ema.reproducibility |
AI-derived candidate's generation is reproducible from the provenance record | designed | rule_packs: kye:rule-pack:bio-chem-governancedictionaries: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
fda-ema.gxp-data-integrity |
GxP data integrity (ALCOA+) for AI-supported regulated decisions | designed | rule_packs: kye:rule-pack:bio-chem-governanceconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
fda-ema.human-accountability |
Named human accountability for an AI-derived candidate entering a regulated stage | designed | rule_packs: kye:rule-pack:bio-chem-governanceconstitution_refs: constitution/36-GOVERNEDUI.md |