Documentation, Method Validation and Presentation

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

Such changes can include increasing batch sizes, adding manufacturing facilities, creating new product presentations, and updating analytical methods. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Common Technical Document [CTD] sections).

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Pharmacy Technician Pulse

CMC Requirements for New Drug Registration in Latin America

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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