ICH Electronic Common Technical Document (eCTD) v4.0

Implementation Guide v1.5

We have adopted this International Scientific Guideline - ICH M8 Expert Working Group

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas publication date: 24 May 2022

Categories: ICH | Multidisciplinary

TGA annotations:

Please refer to the TGA’s webpage TGA Implementation of ICH eCTD v4.0 Specification regarding the TGA’s implementation plan for this guideline.

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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