Application of risk assessment to veterinary biologicals: the perspective of the animal health industry.
The authors review the perspective of the animal health industry on the changing regulatory climate for the registration and free circulation of veterinary vaccines. The industry supports the increased mutual acceptance of technical standards, the harmonization of these standards and the use of proper risk analysis for regulating the free movement of veterinary vaccines. The veterinary vaccine industry is relatively small, but a large number of products are manufactured and the regulation of these products is highly complex. This complexity results in divergent policies on the importation of vaccines, thus limiting the flexibility of the industry in deciding where to develop and manufacture products. The industry welcomes moves by governments to dispense with "zero risk' policies and to adopt consistent scientific risk analysis approaches, in line with the World Trade Organisation agreement on the application of sanitary and phytosanitary measures. The risks involved in the handling, development and manufacture of veterinary biological products are reviewed, and the factors to be taken into account in the assessment and in the management or control of these risks are presented. Dissection of the production process into its various phases enables identification of the critical points and application of specific risk control measures. An important aspect of the risk assessment is the evaluation of the existing testing methods. A specific programme intended to establish the equivalence or harmonization of various test methods is being proposed. In conclusion, the industry is willing to be actively involved in the harmonization process and expects an equally clear political and technical commitment from the governments of the major trading countries.
Folkers
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European Federation of Animal Health (FEDESA), Brussels, Belgium.
Draayer
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Verschueren
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D000818:Animals; D001688:Biological Products / Q000592:standards*; D003132:Commerce / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D005062:European Union; D006801:Humans; D018570:Risk Assessment; D012307:Risk Factors; D014612:Vaccines / Q000592:standards*; D014730:Veterinary Medicine
D001688:Biological Products; D014612:Vaccines