MHRA - MHRA Seeks Stakeholder Feedback on Revised ICH M4Q(R2) Guideline

12th August 2025

MHRA Seeks Stakeholder Feedback on Revised ICH M4Q(R2) Guideline

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation to gather feedback from UK stakeholders on the revised International Council for Harmonisation (ICH) guideline M4Q(R2). This guideline focuses on the quality aspects of pharmaceutical registration and lifecycle management. The consultation aims to ensure that the updated standards align with current practices and regulatory requirements. Stakeholders are encouraged to submit their comments via email to ichconsultations@mhra.gov.uk by 11:59pm on 26th October 2025.

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

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