Adventitious agent safety of urine-derived medicinal products - Scientific guideline

This document considers various aspects of viral saefty of urine-derived medicinal products: it provides guidance in inactivation/removal of virus and its validation.

Keywords: Urine-derived medicinal products, adventitious agents, investigational studies

Current effective version

Guideline adventitious agent safety of urine-derived medicinal products

Adopted Reference Number: EMA/CHMP/BWP/126802/2012 Summary:

This guideline considers various aspects of virus safety of urine-derived medicinal products. Incorporation of effective steps for virus inactivation/removal is considered a key measure towards virus safety and guidance on validation of process steps for virus inactivation/removal is provided.

Document history

Overview of comments received on ‘Guideline on the adventitious agent safety of urine-derived medicinal products’

Reference Number: EMA/CHMP/BWP/248233/2015

Draft guideline on the adventitious agent safety of urine-derived medicinal products

Draft: consultation closed Consultation dates: 22/11/2013 to 31/05/2014 Reference Number: EMA/CHMP/BWP/126802/2012 Summary:

Human urine is used to prepare several products indicated in the field of endocrinology, such as human chorionic gonadotropin (hCG), human menopausal gonadotropin or menotropin (HMG) and follicle-stimulating hormone (FSH) and urokinase products used for thrombolysis. This document addresses specific aspects which should be taken into consideration in the evaluation of viral and TSE safety of medicinal products derived from human urine.