Should you trust Canadian veterinary generic drugs to treat your patients?
Chantal Lainesse
Abstract
Chantal Lainesse
Abstract
The Veterinary Drugs Directorate (VDD) of the Health Products and Food Branch of Health Canada is responsible for the review of pioneer (new) and generic veterinary drug applications for approval in Canada. Up until 2010, the review process for veterinary generic drug submissions by the VDD was guided by the Therapeutic Products Directorate (Health Canada’s human counterpart of the VDD) guidance documents and by the US veterinary generic drugs guidelines. In April 2010, the VDD implemented its own Guidance for Industry entitled: Preparation of Veterinary Abbreviated New Drug Submissions: Generic Drugs (1). This guideline was created with an understanding of critical manufacturing and chemistry requirements, sound pharmacological and statistical principles, as well as key human safety requests, while keeping in mind the unique Canadian veterinary drug market and the growing movement of international harmonization of regulatory approval of veterinary generic drugs.
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The Veterinary Drugs Directorate (VDD) of the Health Products and Food Branch of Health Canada is responsible for the review of pioneer (new) and generic veterinary drug applications for approval in Canada. Up until 2010, the review process for veterinary generic drug submissions by the VDD was guided by the Therapeutic Products Directorate (Health Canada’s human counterpart of the VDD) guidance documents and by the US veterinary generic drugs guidelines. In April 2010, the VDD implemented its own Guidance for Industry entitled: Preparation of Veterinary Abbreviated New Drug Submissions: Generic Drugs (1). This guideline was created with an understanding of critical manufacturing and chemistry requirements, sound pharmacological and statistical principles, as well as key human safety requests, while keeping in mind the unique Canadian veterinary drug market and the growing movement of international harmonization of regulatory approval of veterinary generic drugs.
Key concepts: Veterinary drug, Harmonization, Veterinary Drugs, Guideline, Animal health, Veterinary medicine, Human health, Business