Closed consultation on the draft guidance for preparing veterinary abbreviated new drug submissions: Clinical and human safety requirements

From Health Canada

Current status: Closed

This consultation ran from March 20, 2024 to May 19, 2024

Health Canada was seeking feedback on a draft guidance document on the clinical and human safety requirements for the preparation of veterinary abbreviated new drug submissions (ANDS), more commonly referred to as generic drugs. This proposed guidance is an update of the Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions, Generic Drugs.

Who was the focus of this consultation

This consultation was for veterinary drug industry stakeholders.

Key topics for comment

We were seeking feedback to ensure that this guidance provides as much clarity as possible on the technical clinical and human safety requirements for veterinary generic drug submissions.

Proposed changes to the guidance document included:

The outcome will be a final guidance document that assists industry in understanding:

Once final, this guidance document would replace the clinical and human safety requirements as currently outlined in the Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions, Generic Drugs.

Related links

Contact us

Email: consultationvdd-dmv@hc-sc.gc.ca

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