EMA RELEASES GUIDANCE ON ELEMENTAL IMPURITIES IN MEDICINES
February 8th, 2015
THE EUROPEAN Medicines Agency (EMA) has issued a guideline advising pharmaceutical companies on how to manage elemental impurities in medicines already on the market. The guideline applies to new finished drug products containing purified proteins and polypeptides (including proteins and polypeptides produced from recombinant or non-recombinant origins), their derivatives, and component products, for instance conjugates. Also covered are drug products containing synthetically produced polypeptides, polynucleotides, and oligosaccharides. Advanced therapy medicines ...
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