publicFood and Drug Administration (FDA) · United States · Updated Jun 29, 2026
eMDR System Enhancements - Production Deployment
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.
ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
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