publicSwissmedic (Swiss Agency for Therapeutic Products) · Switzerland · Updated Jun 22, 2026
Adoption of ICH E6(R3) Annex 2 for Good Clinical Practice
MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.
Inspection ReadinessCAPARegulatory Intelligence Lead
SOP Impact3 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Notice
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