International scientific guideline: ICH M4E (R2) Common technical document for the registration of pharmaceuticals for human use - efficacy

About this guideline

TGA adopted date: 28 Feb 2020

Overseas effective date: 31 Jan 2017

Categories: Multidisciplinary

Access this international scientific guideline

Replaces: CPMP/ICH/2887/99 Rev 1 - Efficacy CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: clinical study reports

For more information see International scientific guidelines adopted in Australia.

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.