As reported by EMA, the ICH guideline on elemental impurities in pharmaceuticals (Q3D), has reached ‘step 5’ (implementation). As of June 2016, it is in effect for new marketing authorisation applications, while authorised medicinal products will also be required to comply from December 2017. The guideline consists of three parts: the evaluation of toxicity data for over twenty potential elemental impurities in pharmaceutical products, the establishment of permitted daily exposures (PDEs) for these elements, and the application of a risk-based approach to control elemental impurities in drug products.

European Medicines Agency (2016). ICH guideline Q3D on elemental impurities. Step 5. 25 July 2016 EMA/CHMP/ICH/353369/2013.


The above items were taken from the August/September 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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