RegulatoryMarch 2026
EMA Publishes First Guidance on AI-Generated Biologics: What It Means for European Startups
The European Medicines Agency has released its first regulatory framework specifically addressing AI-designed biological therapeutics, establishing documentation requirements for computational design provenance and in silico validation evidence.
JFInnova Perspective
JFInnova's 9-phase pipeline was built with regulatory transparency from day one. Every computational decision — from scGPT target discovery to ESM-2 directed evolution — is fully documented, versioned, and reproducible, aligning with both FDA and EMA 2026 frameworks.
References
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AI in Biotech: 2026 Drug Discovery Trends
Ardigen · 2026
EMA AI biologics regulatory 2026