The role of international and regional organisations in the regulation of veterinary biologicals.
The authors discuss the role played by international and regional organisations in the registration and testing of veterinary biological products. International organisations which contribute significantly to this field include the Office International des Epizooties (OIE)--through the work of the Standards Commission and the publication of the Manual of standards for diagnostic tests and vaccines--, the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO)--through the work of the Joint FAO/International Atomic Energy Agency (IAEA) Division of Nuclear Techniques in Food and Agriculture in standardising enzyme-linked immunosorbent assay (ELISA) techniques, as well as through WHO Expert Committees. In Europe, the most important regional organisations are the European Commission and the European Pharmacopoeia. In the Americas, the most significant contribution is made by the two specialised institutes of the Pan American Health Organisation (namely INPPAZ [Pan American Institute for Food Protection and Zoonoses] and PANAFTOSA [Pan American Foot and Mouth Disease Centre]), and by the Inter-American Institute for Cooperation in Agriculture. In Africa, PANVAC (the Pan-African Veterinary Vaccine Centre) continues to perform valuable work in testing veterinary vaccines. For the industrialised countries, the Organisation for Economic Co-operation and Development (OECD) is involved in the regulation of biotechnology products and in standardising "good laboratory practice' for vaccine manufacture. A table is presented which summarises and compares the respective roles of these organisations in the harmonization of licensing and testing procedures, the distribution of reference reagents, vaccine testing and the creation of vaccine banks.
Blancou
J
J
Office International des Epizooties, Paris, France.
Truszczynski
M
M
D000349:Africa; D000818:Animals; D001208:Asia; D001688:Biological Products / Q000592:standards*; D005060:Europe; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug; D007886:Legislation, Veterinary; D009656:North America; D010139:Pacific Islands; D011786:Quality Control; D013020:South America; D014480:United Nations; D014944:World Health Organization
D001688:Biological Products