Health Canada
NOTICE
Phased implementation of ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) – Notice to stakeholders
Published: 11/4/2026Detected: 11/5/2026
Summary preview
Phased implementation of ICH M11 (CeSHarP) is expected to move Canadian sponsors toward standardized, electronic, structured harmonised clinical protocol submission practices, potentially impacting how protocols are…
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safety
labeling
quality
manufacturing
#ICH M11
#CeSHarP
#clinical protocol
#structured data
#electronic submission
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