PV Bulletin

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Process Change

publicFDA · USA · Updated Jun 29, 2026

eMDR System Enhancements - Production Deployment

Urgency: High

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Process Change
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