2021 Communication Method Validation 
ISPE
MAY 9, 2023
ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.
ISPE
AUGUST 29, 2022
In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. In July 2021, Health Canada (HC) released an updated draft guidance for its Post-Notice of Compliance (NOC) Changes and solicited public comments. Published 23 March 2021.
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