title: Use of substances of animal origin in pharmaceutics and compliance with the TSE-risk guideline -- a market survey.
abstract: The risk of infection with transmissible spongiform encephalopathy (TSE) from the use of animal-derived substances in drug manufacturing was assessed [Swissmedic. TSE guideline to the ordinance. 2001; http://www.swissmedic.ch/files/pdf/Anleitung_TSE.pdf; The European Directorate for the Quality of Medicines. Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products. In: European Pharmacopoeia 2002; General chapter 5.2.8. http://www.pheur.org/medias/download/50208E.pdf]. In addition, the compliance of the Swiss Market Authorisation holders to implement the Swissmedic TSE guidelines was examined. To assess the compliance with the TSE guideline for products on the Swiss market a representative number of drugs were selected based on a statistical approach. The documents for the biological, anatomical and geographical origin of the animal substances used for drug manufacturing as well as for the manufacturing processes were requested to be provided within a short response period and were subsequently reviewed. A total of 438 drugs with 655 substances of animal origin were assessed during the survey. The documentation provided by the Market Authorisation holders showed, that in general the measures described in the TSE guidelines were implemented well. Therefore, the risk of these pharmaceutics to transmit TSE was considered minimized. However, the TSE documentation provided by drug companies was incomplete for approximately two-third of the drugs at the beginning of the survey. In particular for those containing excipients such as tallow derivatives or gelatine, numerous clarifications were needed prior assessment. The efforts of the drug companies to correspond to regulatory actions and to implement authoritative guidelines should be improved.
authors.affiliation: Swissmedic, Swiss Agency for Therapeutic Products, Erlachstrasse 8, CH-3000 Berne 9, Switzerland. christoph.berger@swissmedic.ch
authors.forename: Christoph N
authors.initials: CN
authors.lastname: Berger
authors.forename: Patrizia
authors.initials: P
authors.lastname: Le Donne
authors.forename: Helena
authors.initials: H
authors.lastname: Windemann
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards*; D002417:Cattle; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D017096:Prion Diseases / Q000473:pathology* / Q000517:prevention & control; D011328:Prions / Q000302:isolation & purification*; D012306:Risk; D018570:Risk Assessment; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D001688:Biological Products; D004364:Pharmaceutical Preparations; D011328:Prions