ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety: questions and answers - Scientific guideline

HumanScientific guidelines

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This document provides additional guidance on the implementation of ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety.

Keywords: Common technical document (CTD), non-clinical data

Current effective version

ICH: M 4 S: Common technical document for the registration of pharmaceuticals for human use - Safety questions and answers - Step 5

Adopted Reference Number: CPMP/ICH/5549/02 Legal effective date:

English (EN) (153.04 KB - PDF)

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