Closed consultation

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

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

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Summary

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

This consultation ran from
12:01am on 12 August 2025 to 11:59pm on 26 October 2025

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

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Published 12 August 2025