title: The American manufacturer's view on the EEC texts and harmonization.
abstract: In a world that has become increasingly smaller with the aid of modern air travel, computers and facsimile machines, the European Community's efforts toward harmonization are applauded by the Animal Health Institute, representing the major U.S. manufacturers of veterinary biological products. The new and proposed directives and guidelines are based on the latest technology and help ensure that only high-quality safe and effective veterinary biologicals are registered in the European Community. These new legislations are, however, significantly different from the current United States (USDA) licensing requirements. The USDA requirements are designed to ensure the safety and efficacy of veterinary biologicals licensed in the United States and have been effective in doing so. Among major differences between EEC and USDA requirements are the EEC requirements for GLP safety tests, GMP for manufacturing, with increased measures for the prevention of cross-contamination, duration of immunity data, and raw material specifications in excess of those required in the United States. Very tight deadlines for implementing these requirements have been established. In the spirit of international harmonization and with the goal of reducing or preventing potential trade barriers, the AHI would like to propose the formation of an international working group consisting of FEDESA, AHI, CVMP, USDA and other international industry and government officials. It is suggested that annual meetings be held in conjunction with either FEDESA or AHI meetings. Issues to be dealt with include standardization of test requirements, time lines for implementation and other issues that could reduce or prevent trade barriers without adversely affecting product quality.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: SmithKline Beecham Animal Health, Lincoln, NE.
authors.forename: H A
authors.initials: HA
authors.lastname: Draayer
authors.forename: L J
authors.initials: LJ
authors.lastname: Hilsabeck
authors.forename: R H
authors.initials: RH
authors.lastname: Miller
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D001688:Biological Products / Q000592:standards*; D004345:Drug Industry; D005062:European Union; D007391:International Cooperation; D007880:Legislation, Drug; D007886:Legislation, Veterinary; D008004:Licensure; D014481:United States; D016885:United States Department of Agriculture
chemical_list: D001688:Biological Products