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Chapter 21 : Licensing and Approval of Antimicrobials for Use in Animals

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Licensing and Approval of Antimicrobials for Use in Animals, Page 1 of 2

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Abstract:

Registration of Veterinary Medicinal Products ( VICH) has been very successful in harmonizing product quality, human food safety, environmental risk assessment, and efficacy requirements, and those guidelines are highlighted in this chapter. There is general agreement within the scientific community that the development of resistant, human-pathogenic bacteria results primarily from the direct use of antimicrobial agents in humans but also from acquisition of resistant organisms or resistance factors from animal and environmental sources. The direct public health concern is that use of antimicrobials in food-producing animals may contribute to the development or dissemination of antibiotic-resistant zoonotic organisms that may contaminate food products at the time of slaughter and subsequently be transmitted to humans. The indirect effect is where animals are treated with antimicrobials and commensal bacteria develop resistance that may be passed to human-pathogenic bacteria. Licensing and approval of antimicrobials for use in animals, particularly food-producing animals, is a complex process involving considerations of efficacy, target animal safety, environmental safety, and human safety, including antimicrobial resistance. The approval process strives to ensure that the products are effective and safe and to manage the risks of adverse effects from their use. After veterinary drugs are licensed and marketed, surveillance is undertaken to ensure the continued safety and efficacy of the products.

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21

Key Concept Ranking

Antimicrobial Resistance
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Figures

Image of Figure 1.
Figure 1.

Resistance development in zoonotic pathogenic bacteria (mechanism A) and commensal bacteria of animal origin (mechanism B).

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
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Image of Figure 2.
Figure 2.

Criteria considered in the U.S. ranking of antimicrobial drugs according to their importance in human medicine.

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
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Image of Figure 3.
Figure 3.

U.S. qualitative risk assessment process for evaluation of animal drugs with regard to microbial safety.

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
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Image of Figure 4.
Figure 4.

Antibiotic resistance review rationale of the ACVM Group, NZFSA.

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
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References

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1. Cerniglia, C. E.,, and S. Kotarski. 1999. Evaluation of veterinary drug residues in food for their potential to affect human intestinal microflora. Regul. Toxicol. Pharmacol. 29: 238261.
2.The EuropeanAgency for the Evaluation of Medicinal Products. 2002. Guidelines on pre-authorization studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products. http://www.emea .eu.int/pdfs/vet/swp/024401en.pdf, accessed 16 February 2005.
3.Expert Advisory Groupon Antimicrobial Resistance. Draft framework on risk assessment with respect to applications referred by the National Registration Authority for Agricultural and Veterinary Chemicals to NHMRC Expert Advisory Group on Antimicrobial Resistance. National Health and Medical Research Council, Canberra, Australia. http://www .nhmrc.gov.au/publications/_files/framwork.pdf, accessed 16 February 2005.
4. Friedlander, L. G.,, S. D. Brynes,, and A. H. Fernandez,. 1999. The human food safety evaluation of new animal drugs, p. 111. In L. Tollefson (ed.), Chemical Food Borne Hazards and Their Control. The W. B. Saunders Co., Philadelphia, Pa.
5. Miller, M. A.,, and C. E. Eirkson. 1997. Environmental assessments for animal drug products. J. Vet. Pharmacol. Ther. 20(Suppl. 1):323325.
6. Miller, M. A.,, and W. T. Flynn,. 2000. Regulation of antibiotic use in animals, p. 760771. In J. F. Prescott,, J. D. Baggot,, and R. D. Walker (ed.), Antimicrobial Therapy in Veterinary Medicine, 3rd ed. Iowa State University Press, Ames.
7.New Zealand Food Safety Authority. 2000. Guidelines for risk assessment and hazard analysis under the Agricultural Compounds and Veterinary Medicines Act 1997,September-October 2000 . http://www.nzfsa.govt.nz/acvm/publications/ standards-guidelines/risk-hazard-guideline.pdf, accessed 16 February 2005.
8. Tollefson, L.,, and M. A. Miller. 2000. Antibiotic use in food animals: controlling the human health impact. J. AOAC Int. 83:245254.
9.U.S. Food and Drug Administration, Center for Veterinary Medicine. 1989. Guideline 33: Target animal safety guidelines for new animal drugs. http://www.fda.gov/cvm/guidance/ guideline33.html, accessed 16 February 2005.
10.U.S. Food and Drug Administration, Center for Veterinary Medicine. 2003. Guidance for Industry #152: Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. http://www.fda.gov/cvm/antimicrobial/antimicrobial.html, accessed 16 February 2005.
11.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH Harmonized Tripartite Guideline GL6. Environmental impact assessment (EIAs) for veterinary medicinal products (VMPs)—Phase 1. http://vich.eudra.org/ htm/ guidelines.htm.
12.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH Harmonized Tripartite Guideline GL9. Good Clinical Practice. http://vich.eudra.org/htm/guidelines. htm.
13.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH Harmonized Tripartite Guideline GL22. Studies to evaluate the safety of residues of veterinary drugs in human food: reproduction toxicity testing. http:// vich.eudra.org/htm/guidelines.htm.
14.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH Harmonized Tripartite Guideline GL23. Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing. http://vich.eudra. org/htm/guidelines.htm.
15.VICH (International Cooperationon Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2003. VICH Harmonized Tripartite Guideline GL27. Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance. http://vich.eudra.org/ htm/guidelines.htm.
16.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2002. VICH Harmonized Tripartite Guideline GL28. Studies to evaluate the safety of residues of veterinary drugs in human food: carcinogenicity testing. http://vich.eudra.org/ htm/guidelines.htm.
17.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2002. VICH Harmonized Tripartite Guideline GL31. Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (90-day) toxicity testing. http://vich.eudra.org/htm/guidelines.htm.
18.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2002. VICH Harmonized Tripartite Guideline GL32. Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing. http://vich.eudra.org/htm/guidelines.htm.
19.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2004. VICH Harmonized Tripartite Guideline GL33. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to testing. http://vich.eudra .org/htm/guidelines.htm.
20.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2004. VICH Harmonized Tripartite Guideline GL36. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI. http://vich.eudra.org/htm/guidelines.htm.
21.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2004. VICH Harmonized Tripartite Guideline GL37. Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (chronic) toxicity testing. http://vich.eudra.org/htm/guidelines.htm.
22.VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products).2003. VICH Harmonized Tripartite Guideline GL38. Draft environmental impact assessment (EIAs) for veterinary medicinal products (VMPs)—Phase II. http://vich.eudra .org/htm/guidelines.htm.

Tables

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Table 1.

Consumption table for calculating ADI

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
Generic image for table
Table 2.

New Zealand consumption table for calculating ADI

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
Generic image for table
Table 3.

Examples of ranking of drugs based according to their importance in human medicine in New Zealand and the United States

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21
Generic image for table
Table 4.

Examples of risk management options in the United States based on the level of risk identified (high, medium, or low)

Citation: Tollefson L, Morris D, Boland C, Kay J. 2006. Licensing and Approval of Antimicrobials for Use in Animals, p 361-374. In Aarestrup F (ed), Antimicrobial Resistance in Bacteria of Animal Origin. ASM Press, Washington, DC. doi: 10.1128/9781555817534.ch21

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