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

HumanScientific guidelines

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This document provides detailed guidance on the information to be included in the safety non-clinical overview and non-clinical summaries sections of the common technical document.

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 - Step 5

Adopted Reference Number: CPMP/ICH/2887/99 Legal effective date:

English (EN) (620.04 KB - PDF)

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