---
title: "FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines — KYE Protocol™ coverage"
description: "FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/fda-ema/
lang: en
source: "KYE Protocol"
---

> FDA + EMA — AI / Provenance Expectations for AI-Derived Candidates in Regulated Pipelines coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

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% of in-scope requirements covered.

4 requirements · 4 in scope (4 designed). The 50% is weighted over the in-scope base.

**Source:** FDA's framework / draft guidance on the use of AI in the development of drug and biological products, and the EMA's reflection paper on the use of AI across the medicinal-product lifecycle,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-governance` **dictionaries**: `internal` **constitution\_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-governance` **dictionaries**: `internal` **constitution\_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-governance` **constitution\_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-governance` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/).