ICH M4 Common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD - Scientific guideline

HumanScientific guidelines

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Guidance on the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products).

Keywords: Common technical document (CTD), data format

Current effective version

ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD - Step 5

Adopted Reference Number: CPMP/ICH/2887/99

English (EN) (438.43 KB - PDF)

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