Open consultation

Consultation on the Revised International Council for Harmonisation Guideline M4Q(R2)

From:
Medicines and Healthcare products Regulatory Agency
Published
12 August 2025

Summary

The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline, M4Q(R2).

This consultation closes at

Consultation description

The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline to capture quality information for the registration and lifecycle management of pharmaceuticals for human use.

Documents

ICH M4Q(R2) Public Consultation

HTML

Ways to respond

Email to:

ichconsultations@mhra.gov.uk

Updates to this page

Published 12 August 2025

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