2020 Article Communication Method Validation 
ISPE
MAY 9, 2023
This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. As of 30 March 2020, EMA no longer provides printed certificates: only electronically signed and authenticated certificates will be issued. Published 2020.
ISPE
AUGUST 29, 2022
This article will examine the current global regulatory submission workflow for postapproval CMC changes and will propose principles to streamline regulatory submission authoring through the utilization of ICH Q12 concepts, in combination with SCDM. The European Medicines Agency (EMA) issued its implementation guidance in March 2020.
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