Document Detail


Antimicrobial resistance and the guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
MedLine Citation:
PMID:  22849284     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
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:
H Marion
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Revue scientifique et technique (International Office of Epizootics)     Volume:  31     ISSN:  0253-1933     ISO Abbreviation:  Rev. - Off. Int. Epizoot.     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-08-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8712301     Medline TA:  Rev Sci Tech     Country:  France    
Other Details:
Languages:  eng     Pagination:  299-306     Citation Subset:  IM    
Affiliation:
VICH Secretariat, c/o International Federation for Animal Health, rue Defacqz, 1, 1000 Brussels, Belgium.
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