CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products

Consensus statement on the bio-safety of urinary-derived gonadotrophins with respect to Creutzfeldt-Jakob disease.

Human transmissible spongiform encephalopathies (TSE) encompass a group of rare neurodegenerative diseases. In April 2004, a group of international experts and regulators met in Buenos Aires, Argentina, to review the safety and to reach consensus on the use of urinary-derived gonadotrophins with respect to TSE. Iatrogenic transmission of Creutzfeldt-Jakob Disease (CJD) from pituitary-derived go...

Committee for Medicinal Products for Human Use (chmp) Guideline on the Investigation of Manufacturing Processes for Plasma-derived Medicinal Products with Regard to Vcjd Risk

Detection of Prion Protein in Urine-Derived Injectable Fertility Products by a Targeted Proteomic Approach

BACKGROUND Iatrogenic transmission of human prion disease can occur through medical or surgical procedures, including injection of hormones such as gonadotropins extracted from cadaver pituitaries. Annually, more than 300,000 women in the United States and Canada are prescribed urine-derived gonadotropins for infertility. Although menopausal urine donors are screened for symptomatic neurologica...

The Safety of Human-derived Products with regard to Variant Creutzfeldt-Jakob Disease

WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies

WHO guidelines on tissue infectivity distribution in transmissible spongiform encephalopathies. 1.Creutzfeldt-Jakob syndrome – pathogenicity. 2.Creutzfeldt-Jakob syndrome – diagnosis. 3.Encephalopathy, Bovine spongiform – transmission. 4.Encephalopathy, Bovine spongiform – pathogenicity. 5.Prion diseases. 6.Blood transfusion. 7. Th e designations employed and the presentation of the material in...