2019-2020 RCC Work Plan: Veterinary Drugs

Canadian Department: Health Canada, Health Products and Food Branch

United States Department/Agency: Food and Drug Administration, Department of Health and Human Services

Regulatory Cooperation Statement:

Health Canada’s Health Products and Food Branch and the United States (U.S.) Food and Drug Administration’s (FDA) Department of Health and Human Services will continue to coordinate their respective submission and review processes for veterinary drug applications to enable simultaneous product reviews. Further work in this area will also explore the expansion of Simultaneous Review to generic animal drug applications.

Work Plan:
Initiative Desired outcome(s) Activities Reporting

Build on the work accomplished under the RCC Joint Forward Plan by exploring expansion of simultaneous reviews to generic animal drug applications

  • Conduct simultaneous reviews of generic animal drug applications.
  • Improve animal drug availability in the United States and Canada.
  • Consult and share information with industry stakeholders including the generic animal drug industry (March – April 2020).

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  • Exchange information on the regulatory frameworks and scientific review processes for generic animal drugs in each jurisdiction between agencies (summer, 2019).

Fall 2019: Completed
Final update: Health Canada and the U.S. FDA exchanged this information in a series of bilateral meetings in summer, 2019.

  • Define criteria for regulatory authorities to identify candidate generic animal drug applications for simultaneous review (January – March 2020).

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  • Identify a simultaneous review of a generic animal drug application (September 2020).

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  • Discuss lessons learned from pilot simultaneous reviews of a generic animal drug and any next steps (2021).

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