Plasma-derived medicines are prepared from human blood. They are used to treat and prevent serious diseases and include coagulation factors and immunoglobulin. Urine-derived products are made from pooled human urine and include certain hormone-based treatments and urokinase products (medicines used to break up blood clots.
Basic Evaluations conceded out by the European Medicines Agency (EMA) and proficient establishment in the EU Member States have confirmed that there is no increased risk of contamination with the Zika virus for patients who take plasma-derived or urine-derived medicines.
EU regulators sought assurance that there is no risk of the virus contaminating the final product and affecting the patients taking it if the plasma or urine came from donors who had constricted the Zika virus.
EMA’s Committee for Medicinal Products for Human Use (CHMP) has addressed the potential risk from Zika virus for plasma-derived medicinal products. The CMDh has corresponding the assessment by EU Member States on the potential risk from Zika virus for urine-derived medicinal products.
The CHMP concluded at its meeting last week that the manufacturing processes used for plasma-derived products, including for example the solvent method to inactivate viruses, pasteurization and virus filtration inactivate or remove the Zika virus from the finished product.
Relating to urine-derived products, the CMDh concluded that the manufacturing processes for these products contain balancing steps with inactivation ability for enveloped viruses, which are adequate for Zika virus safety of these products.
Date: 21/09/2016