title: Antimicrobial resistance and the guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
abstract: The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is an international tripartite cooperation programme that brings together regulatory authorities and industry representatives from the European Union, Japan and the United States, with Australia, New Zealand and Canada as observers. VICH aims to improve international coordination and cooperation to achieve greater harmonisation of the requirements for veterinary product registration in the regions concerned. VICH develops harmonised data requirements, i.e., standards for the scientific studies on quality, safety and efficacy that are required to obtain a marketing authorisation for a veterinary medicinal product. It does this by publishing guidelines that provide uniform and consistent guidance for sponsors to follow in developing data for application dossiers as well as for post-marketing safety monitoring of veterinary medicinal products. Of the 49 VICH guidelines that have been developed so far, two guidelines in particular address issues related to antimicrobial resistance.
authors: VICH Secretariat, c/o International Federation for Animal Health, rue Defacqz, 1, 1000 Brussels, Belgium.
authors: H
authors: H
authors: Marion
mesh_terms: D000818:Animals; D004352:Drug Resistance, Microbial; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies / Q000458:organization & administration*; D007391:International Cooperation; D007564:Japan; D012042:Registries / Q000592:standards*; D014481:United States; D019155:Veterinary Drugs
chemical_list: D019155:Veterinary Drugs