UK. The Committee on Safety of Medicines (CSM) has advised that no human plasma or urine used in the production of medicines should be sourced from a country with one or more endogenous cases of variant Creutzfeldt-Jacob Disease (vCJD). The CSM continually reviews the safety of medicines that are prepared from human and animal materials, particularly with respect to any potential risk from transmissible spongiform encephalopathies (TSEs). In 1998 the CSM, taking into account the number of vCJD reported in the UK, recommended that human blood plasma sourced from the UK should not be used to prepare medicines. Later this restriction was extended to also include plasma from all other countries where at least one endogenous case of vCJD (indigenous to that country) had been reported. Still later the same precautionary principle was extended to urine-derived products since the abnormal prion protein was detected in the urine of patients with TSEs. The CSM advises that where possible plasma and urine should be sourced from countries with no or low risk of BSE and that that plasma pools for fractionation and urine used for the manufacture of medicines should be restricted to a single country of origin. Use of plasma derived products in medicines should be limited and where available, recombinant alternatives should be used.
CSM Safety Review, Feb 2003. Available from URL: http://www.mca.gov.uk