ICH M4Q Location issues for common technical document for the registration of pharmaceuticals for human use - quality: questions and answers

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Questions and answers

Reference numberCPMP/ICH/4680/02
Published01/08/2003
KeywordsCommon technical document (CTD), quality
DescriptionThis document provides additional guidance for the preparation of an application file in the common technical document - quality section (CTD-Q) format. It addresses the relationship between linked CTD-Q sections for certain parameters, such as polymorphism, impurities or particle size. This document also clarifies location issues - it indicates in which CTD-Q section(s), requested information should be placed.


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