Regulatory frameworks for AI in drug development are converging fast. The FDA, EMA, and ISPE have each published major guidance in the past 18 months — and most clinical research teams are still piecing together what it means for their operations. This section maps the regulatory landscape, breaks down each framework into actionable guidance, and provides the tools to assess your organization's readiness.
| Domain | FDA 7-Step | EMA Reflection | GAMP AI Guide | EU AI Act |
|---|---|---|---|---|
| Risk-based approach | ● Core framework | ● Foundational | ● Inherited | ● Classification |
| Drug discovery | ○ Out of scope | ● Covered | ◐ If GxP impact | ○ Exempt (R&D) |
| Clinical trials | ● Primary focus | ● Covered | ◐ GCP systems | ● High-risk class |
| Manufacturing | ● CQA/process | ● Covered | ● Primary focus | ◐ If SaMD |
| Post-marketing / PV | ● Included | ● Covered | ◐ If GxP impact | ◐ Monitoring |
| Model validation | ● Credibility plan | ◐ Principles | ● Lifecycle CSV | ◐ Conformity |
| Data governance | ● Fit-for-use | ● ALCOA+ aligned | ● Integrity focus | ● Required |
| Human oversight | ● Influence factor | ● Human-centric | ◐ QMS role | ● Mandated |
| Lifecycle monitoring | ● Drift / adequacy | ● Continuous | ● Core concept | ● Post-market |
| Audit trail / 21 CFR 11 | ◐ Referenced | ◐ Annex 11 | ● Detailed | ◐ Documentation |
| Vendor qualification | ◐ Implied | ◐ Responsibility | ● Supplier mgmt | ● Supply chain |
| Legal status | Draft guidance | Adopted paper | Industry guide | Regulation (law) |
● Detailed coverage ◐ Partial / principles-level ○ Out of scope or exempt
Each AI Stack guide includes embedded compliance callout boxes covering the regulatory requirements specific to that workflow stage.
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