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  • Regulatory NewsRegulatory News

    EMA Adopts New Guideline on Urine-Derived Product Safety

    The European Medicines Agency (EMA) has adopted a new guideline on the regulatory requirements for ensuring the viral safety of urine-derived medicinal products. Background 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, spe...
  • EMA Issues New Guideline on Controlling Disease Transmission Risks in Urine-Based Products

    The European Medicines Agency (EMA) is out with a new draft guideline intended for sponsors of human urine-based products, saying a standardized approach is needed to ensure that products are free from dangerous contaminants. As regulators explain in the guideline- on the adventitious agent safety of urine-derived medicinal products -human urine is used in several products, including human chorionic gonadoptropin (hCG), human menopausal gonadotropin or menotropin (HMG)...
  • Canada: CADTH Finds Urine Test as Good as Blood for Type II Diabetes Monitoring

    The Canadian Agency for Drugs and Technologies in Health (CADTH) Rapid Response Report found in patients with type II diabetes no statistically significant difference between two self-monitoring strategies, urine and blood testing, in glycemic control, measured by HbA1c levels, or in the proportion of patients reaching target HbA1c.  It concluded that findings from large randomized controlled trials comparing benefits of the two monitoring strategies and economic ...