2020 Article Method Validation Packaging 
ISPE
MAY 9, 2023
This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from.
ISPE
AUGUST 29, 2022
For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. The European Medicines Agency (EMA) issued its implementation guidance in March 2020.
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