EMA Sets Elemental Impurities Implementation Dates

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New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.


New drug products submitted for approval in Europe must comply with the new ICH Q3D Guidelines for Elemental Impurities, in June 2016. Existing products must comply in December 2017. The implementation dates set by the European Medicines Agency are earlier than those established by the US Pharmacopeial (USP) Convention.

In December 2014, ICH released the Step 4 version of ICH Q3D, Guidelines for Elemental Impurities, to regional standards organizations for implementation. The document stated that application of ICH Q3D to existing products was not expected prior to 36 months after publication.


On Jan. 15, 2015, USP announced plans to establish Jan. 1, 2018 as the new date of applicability of General Chapters <232> Elemental Impurities-Limits and <2232> Elemental Contaminants in Dietary Supplements. The date change was made to align more closely with implementation of ICH Q3D.

FDA has not announced implementation dates, but has listed a proposed guidance, Elemental Impurities in Drug Products Marketed in the United States, as a proposed new guidance for 2015.

Source: European Medicines Agency