THE ROLE OF INTERNATIONAL AND REGIONAL ORGANIZATIONS IN THE REGULATION OF VETERINARY BIOLOGICALS

The authors discuss the role played by international and regional orga nisations in the registration and testing of veterinary biological pro ducts. International organisations which contribute significantly to t his field include the Office International des Epizooties (OIE) - thro ugh the work of the Standards Commission and the publication of the Ma nual of standards for diagnostic tests and vaccines -, the Food and Ag riculture Organisation of the United Nations (FAG) ann the World Healt h Organisation (WHO) - through the work of the Joint FAO/International Atomic Energy Agency (IAEA) Division of Nuclear Techniques in Food an d Agriculture in standardising enzyme-linked immunosorbent assay (ELIS A) techniques, as well as through WHO Expert Committees. In Europe, th e most important regional organisations are the European Commission an d the European Pharmacopoeia. In the Americas, the most significant co ntribution is mane by the two specialised institutes of the Pan Americ an Health Organisation (namely INPPAZ [Pan American Institute for Food Protection and Zoonoses] and PANAFTOSA [Pan American Foot and Mouth D isease Centre]), and by the Inter-American Institute for Cooperation i n Agriculture. In Africa, PANVAC (the Pan-African Veterinary Vaccine C entre) continues to perform valuable work in testing veterinary vaccin es. For the industrialised countries, the Organisation for Economic Co -operation and Development (OECD) is involved in the regulation of bio technology products and in standardising 'good laboratory practice' fo r vaccine manufacture. A table is presented which summarises and compa res the respective roles of these organisations in the harmonisation o f licensing and testing procedures, the distribution of reference reag ents, vaccine testing and the creation of vaccine banks.