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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.

Documentation 52
Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52
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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 5 (2003): 395–413. Lakerveld, B. Benyahia, P. Barton, R. Braatz, et al. doi:10.1002/anie.201305429

Dosage 52
Dosage Chemotherapy Documentation Labelling 52
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