ICH E6(R3) Guideline for Good Clinical Practice

About this guideline

The TGA has prepared comments to assist stakeholders in complying with the ICH Guideline for Good Clinical Practice in accordance with local regulatory requirements. A transition period from 13 January 2026 to 13 January 2027 is included to allow stakeholders time to meet the updated requirements. For more information see ICH Guideline for Good Clinical Practice. 

Adopted by the TGA: 16 January 2026

Overseas effective date: 6 January 2025

Replaces: Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2)

Categories: ICH | Efficacy | Clinical Trials

For more information see International scientific guidelines adopted in Australia.