title: Comparison of requirements in the European Union and United States of America for pre-clinical viral safety testing of veterinary vaccines.
abstract: Of paramount importance in ensuring the safety of live and inactivated veterinary vaccines is demonstration of freedom from extraneous agents in biological starting materials used in their production. Both the European Union (EU) and United States of America (US) provide regulations and guidelines on extraneous agent testing of veterinary vaccines including guidance from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Pharmacopoeia (Ph. Eur.) and the USDA Code of Federal Regulations, Title 9 (9CFR). There are distinct requirements prescribed in EU and US regulations and guidelines. The differences in EU and US requirements for extraneous agent testing of starting materials are such that there may be occasions when no one test may satisfy both sets of regulations for a given scenario. For compliance with both, for global licensing purposes it may therefore be necessary to perform additional tests and/or to justify methods chosen from one set of regulations over another, based on a variety of factors.
authors.affiliation: BioReliance Ltd., Todd Campus, West of Scotland Science Park, Glasgow G200XA, UK. sarah.sheridan@bioreliance.com
authors.forename: Sarah
authors.initials: S
authors.lastname: Sheridan
authors.forename: Julie
authors.initials: J
authors.lastname: Coughlin
mesh_terms: D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D018570:Risk Assessment / Q000379:methods; D014481:United States; D014611:Vaccination / Q000662:veterinary*; D014612:Vaccines / Q000592:standards*; D019155:Veterinary Drugs / Q000592:standards*
chemical_list: D014612:Vaccines; D019155:Veterinary Drugs