publicInternational Council for Harmonisation (ICH) · Global · Updated Jul 30, 2026
Updated support package for ICH M8: Electronic Common Technical Document (eCTD)
Regulatory operations teams must ensure compliance by compiling safety submissions in accordance with the new eCTD technical specifications and avoiding outdated support materials.
Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Technical Support Package
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