Download Regulated by the Canadian Food Inspection Agency under the

Veterinary Drugs Directorate &
Canadian Center for Veterinary Biologics
Regulatory Frameworks and VICH Guidelines:
Perspectives from an Observer Country
MJ Ireland
4th VICH Outreach Forum
June, 2014
Canada’s Participation in VICH
• Canada is a global partner in the regulation of veterinary drug
• Granted observer status in VICH in 2002 (Tokyo, Japan)
• Participation in Steering Committee meetings
• Scientific experts fully engaged in guideline development
Legal Framework for Veterinary Drugs and
Biologics in Canada
• Veterinary Drugs: Regulated by Health Canada
under the authority of the Food and Drugs Act and
Regulations
• Veterinary Biologics: Regulated by the Canadian
Food Inspection Agency under the authority of the
Health of Animals Act and Regulations
Regulatory Frameworks & VICH Guidelines
• When adopted, VICH GLs are administrative tools that do
not have the force of law
• Flexibility in approach is permitted if justified and
scientifically substantiated
• Regulators reserve the right to request additional
information or material if it’s justified and documented
Example - Efficacy of Anthelmintics VICH GLs 7, 12, 13,
14,15, 16, 19 – efficacy calculations
Implementing VICH Guidelines
Use of GLs by the Canadian Regulators for Veterinary Drugs and Biologics
• The majority of VICH GLs are adopted by Canada – 38 Guidelines
• Guidelines not fully adopted
• unsupported by regulatory frameworks – Ecotoxicity
• GLs under consideration: example VICH GL 50 – Criteria to Waive
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Target Animal Batch Safety Testing for Inactivated Vaccines for Vet Use
considering the risk
Product history in countries of licensure
building experience and confidence
developing the policy and requirements for manufacturers
Thank you