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

We have adopted this International Scientific Guideline – ICH M4E (R2); EMA/CPMP/ICH/2887/1999 
 

Last updated

About this guideline

Adopted by the TGA: 28 February 2020

Overseas effective date: 31 January 2017

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

Categories: ICH | Multidisciplinary

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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For more information see International scientific guidelines adopted in Australia.

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