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

This 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.

Keywords: Common technical document (CTD), quality

Current effective version

ICH: M 4 Q: Location issues for common technical document for the registration of pharmaceuticals for human use - Quality questions and answers - Step 5

AdoptedReference Number: CPMP/ICH/4680/02Legal effective date: 01/08/2003