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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

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. Journal of Pharmaceutical Sciences (2021). Sugrue-Richards, and G. doi:10.1016/j.xphs.2021.09.046.

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CMC Requirements for New Drug Registration in Latin America

ISPE

This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. 21 Similarly, the FDA Center for Drug Evaluation and Research (CDER) began issuing electronic CPPs (eCPP) starting December 2021. Published 13 May 2021. leychile/navegar?idNorma=1159473