UK MHRA · November 19, 2025

Consultation on the International Council for Harmonisation Guideline Q3E for Extractables and Leachables

MHRA seeks stakeholder feedback on ICH Q3E guideline for assessment and control of extractables and leachables.

Medium obligation Framework Medical Devices & IVD Pharmaceuticals UK Medical devicesPharmaceuticals

The MHRA is consulting with UK stakeholders to gather feedback and comments on an international guideline on the assessment and control of extractables and leachables.

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Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.