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CMC Requirements for New Drug Registration in Latin America

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.

Documentation 52
Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies.

Documentation 52
Documentation FDA Communication Packaging 52
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