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EMA Issues Guidances on Implementation of ICH Guide on Elemental Impurities

July 18, 2016

One week after the FDA tackled compliance with international standards for restricting elemental impurities in finished drugs, the EMA has issued guidance on the same topic.

A draft EMA guidance showcases “the practical implementation” of the International Council for Harmonization’s Q3D Guideline for Elemental Impurities. More specifically, the document reminds drugmakers to include a summary of their risk management strategies on elemental impurities in their marketing authorization applications.

While drugmakers have been critical of the ICH guideline, saying it requires an inordinate amount of cooperation with suppliers, the EMA’s guidance attempts to allay these concerns by showing how the ICH standards dovetail with EMA’s regulatory expectations.

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