EMA Adopts New Guideline on Urine-Derived Product Safety

Regulatory NewsRegulatory News | 01 June 2015 |  By 

The European Medicines Agency (EMA) has adopted a new guideline on the regulatory requirements for ensuring the viral safety of urine-derived medicinal products.


Human urine is an essential component in certain hormone-based treatments and some products used to break up blood clots.

Products derived from human urine have been available in Europe since the 1970s. While numerous improvements have been made to ensure the safety and purity of these products, special care must be taken during manufacturing to ensure any viruses are removed or inactivated.

The emergence of new viruses, such as variant Creutzfeldt-Jakob disease (vCJD), prompted EMA to investigate the viral safety of urine-derived products in the mid-2000s. Now, the agency has adopted a new guideline, On the adventitious agent safety of urine-derived medicinal products, which will enter into effect in December 2015.

Safety Considerations

In the guideline, EMA outlines several areas of concern for manufacturers to address when developing and producing products derived from human urine.

EMA says companies should consider establishing appropriate exclusion criteria for donor panels. The agency says exclusion criteria are already in place for most urine-derived hormone products, as they rely on "relatively small well-defined donor population[s]." EMA admits this may be difficult to do for urokinase products, which rely on much larger donor pools. For both classes of products, EMA recommends companies implement measures to verify donor health.

Because it is difficult to ensure that viruses are not present in donated urine, viral safety is primarily achieved during manufacturing processes. As such, EMA instructs manufacturers to verify that their manufacturing processes are capable of removing or inactivating a "broad range of viruses representing various physico-chemical properties." Processes such as pasteurization, nanofiltration and alkali treatment can be implemented to clear viruses during the manufacturing stage.

Companies manufacturing biological products, including urine-derived medicinal products, are required to validate their processes for virus removal by conducting inactivation and removal studies. EMA says specific attention should be paid to the types of viruses selected for these studies, with a focus on viruses commonly found in human urine, such as hepatitis B and human papilloma virus. Additionally, companies are instructed to include viruses found in feces that could potentially enter a donation.


Guideline on the adventitious agent safety of urine-derived medicinal products


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