Summary

EMA Implementation Strategy of ICH Q3D Guideline

Author:

Monitoring and Reporting Work Group

On 08 March 2017, EMA issued an implementation strategy of the ICH Q3D guideline that addresses specific considerations to enable the practical implementation of the guideline for elemental impurities in the European Union.  Topics covered in this document include drug product and component approaches to elemental impurity risk management, special considerations for intentionally added elements, and ASMF/CEP dossier expectations for transparency of risk management for drug product manufacturers.

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