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Revised post notice of compliance changes quality guidances: ICH Q12 interim implementation for biologics and Schedule C drugs
Published: 5/15/2026Detected: 5/16/2026

Summary preview

Implements ICH Q12 interim changes-management expectations in Canada for biologics and Schedule C drugs, affecting how post-approval quality changes are planned, submitted, and justified.

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manufacturing
quality
#Health Canada
#post-NOC quality changes
#NOC/c
#ICH Q12
#biologics

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