Veterinary Drugs Directorate Canadian Center for Veterinary Biologics

Veterinary Drugs Directorate & Canadian Center for Veterinary Biologics Regulatory Frameworks and VICH Guidelines: Perspectives from an Observer Country MJ Ireland 4 th 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 • • 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