EMA releases medicine impurities advice

Published: 30-Aug-2013
Regulatory

Useful for the final stages of medicine development


Quality guidelines have been released by the European Medicines Agency (EMA) on how pharma companies should limit the presence of certain potentially toxic impurities in newly developed medicines. These include drug products containing proteins and polypeptides, synthetically produced polypeptides, polynucleotides, and oligosaccharides.

EMA said the guidance would be useful for final stages of medicine development, but not early research.

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