Regulations/Good AI Practice/Articles & Clauses
Articles & Clauses · Good AI Practice

Articles & Clauses for Good AI Practice.

This page identifies the source units that future interpretation and evidence artifacts must trace back to. It is the place for articles, clauses, principles, annexes, definitions, and protected-standard boundaries, not generic commentary.

Source basis: Guiding principles for Good AI Practice in drug development and related lifecycle guidanceUse: evidence-readinessBoundary: not legal advice
Good AI Practice TRACE FDA/EMA GOOD AI PREMA/HMA AI LIFECFDA AI DRUG DEVEGMLP MEDICAL-DEV
/ Source units

The chapter holds the source skeleton.

articles · clauses · principles

This page does not flatten Good AI Practice into a generic checklist. It identifies the specific source units that future interpretation, evidence objects, and public artifacts must trace back to.

Source unit 01

FDA/EMA Good AI Practice principles

Common principles for AI in drug development released in January 2026.

Source unit 02

EMA/HMA AI lifecycle reflection

Medicinal-product lifecycle context for AI use and risk management.

Source unit 03

FDA AI drug development page

US source hub for AI in drug-development activity.

Source unit 04

GMLP medical-device principles

Comparator source for device ML development; separate from medicines AI.

Source unit 05

Context-of-use principle

The same model can carry different risk depending on decision context.

Source unit 06

Lifecycle management principle

Model performance, change, and monitoring remain active after deployment.

/ Public boundary

Protected material stays protected.

citation not copying
Boundary

Use source-owner titles, status, and public summaries; do not reproduce protected standards or paid guide content.

cite · summarise · trace · do not copy

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