ICH topic E 4 - Dose response information to support drug registration

We have adopted this International Scientific Guideline – ICH E4; CPMP/ICH/378/95

Last updated

16 December 2024

About this guideline

Overseas effective date: November 1994

Categories: ICH | Efficacy

Clinical efficacy and safety | General

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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