title: European Pharmacopoeia (EP), USDA and MAFF standards--will they ever be harmonised under the VICH umbrella?
abstract: Harmonisation of standards can have benefits for both users and manufacturers of vaccines. It also helps regulatory authorities when products are assessed to have a uniform standard in different regions. The first priority for harmonisation has to be the elimination of duplicate testing for the same purpose, for example tests for safety, immunogenicity and batch potency. A further priority is to harmonise batch-testing requirements first, since duplication of testing affects production batches. Fish vaccines present particularities as far as harmonisation between regions is concerned because of geographical, climatic and other factors. A commitment from regulatory authorities and manufacturers is a precondition for harmonisation. The different parties should commit themselves to harmonisation within a reasonable time and to implementing their decisions promptly. When there is a commitment on the part of all participants to work together in developing common science-based regulatory standards, then the optimal conditions exist. Harmonisation is time-consuming and costly but in the end the benefits can no doubt exceed the investment. Harmonisation also needs a forum since the present terms of reference of regulatory and standardisation bodies do not cover this. The only forum at present is the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH), which is a tripartite activity involving the European Union, Japan and the U.S.A. Before deciding to propose inclusion in the VICH programme, a preliminary study should be carried out to assess the benefits expected, the obstacles to harmonisation and the feasibility of achieving a satisfactory result. In the framework of VICH, there have been some successful harmonisation projects for veterinary vaccines: residual formaldehyde determination, and residual moisture determination. A harmonised proposal for mycoplasma testing is now available for public comment. Work on extraneous agents testing for avian and mammalian viral vaccines is well advanced.
authors.affiliation: European Pharmacopoeia, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France. peter.castle@pheur.org
authors.forename: P
authors.initials: P
authors.lastname: Castle
mesh_terms: D000818:Animals; D004345:Drug Industry / Q000592:standards; D005062:European Union; D005393:Fish Diseases / Q000517:prevention & control*; D033161:Government Regulation; D007391:International Cooperation; D007564:Japan; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011786:Quality Control; D012015:Reference Standards; D014481:United States; D014612:Vaccines / Q000592:standards*; D019155:Veterinary Drugs / Q000592:standards*
chemical_list: D014612:Vaccines; D019155:Veterinary Drugs