Friday, 21 October 2016

EMA Determines Certain Drugs Safe from Zika Contamination


On Sept. 21, 2016, the European Medicines Agency (EMA) announced there is no increased risk of Zika contamination for patients who take plasma- or urine-derived drugs. The conclusion was made after an assessment was carried out by EMA and authorities in EU Member States to determine if drugs produced from body fluids, which might be sourced from parts of the world where Zika is prevalent, could contaminate the final product with the virus.

EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that manufacturing processes such as solvent/detergent methods, pasteurization, and virus filtration inactivate or remove the Zika virus from the finished product. Steps for the inactivation/removal capacity for enveloped viruses are included in the manufacturing processes for urine-derived products. CHMP considers these steps sufficient to keep patients safe from Zika contamination.

According to EMA, plasma-derived drugs, which are manufactured from human blood, include coagulation factors and immunoglobulins. Urine-derived products, which are manufactured from pooled human urine, include hormone-based treatments and urokinase products.

Posted by Dr. Tim Sandle

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