Consultation on the draft guidance for preparing veterinary abbreviated new drug submissions: Clinical and human safety requirements

From Health Canada

Health Canada is seeking feedback on a draft guidance document on the clinical and human safety requirements for the preparation of veterinary abbreviated new drug submissions (ANDS), more commonly referred to as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.

Join in: How to participate

Send us an email

Send an email to consultationvdd-dmv@hc-sc.gc.ca to:

• request a copy of the draft guidance document on the preparation of veterinary generic drug submissions
• provide your feedback, using the subject line "Comments: Consultation on draft guidance on the preparation of veterinary ANDS, clinical and human safety requirements"

Who is the focus of this consultation

This consultation is for veterinary drug industry stakeholders.

Key topics for comment

We are 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 include:

• removing the quality requirements for veterinary generic drugs and including them in a separate guidance document
• Guidance on the preparation of veterinary NDS and ANDS, quality requirements, is also currently under consultation
• clarity on the clinical and human safety submission requirements for veterinary generic drugs
• more clarity on ANDS eligibility criteria, including specific examples
• additional information on the interpretation of “conditions of use” as defined in C.08.002.1(1)(d) of the Food and Drug Regulations
• a revised modular format for more user-friendly navigation

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

• ANDS eligibility criteria
• the associated clinical and human safety requirements
• appropriate supporting information for a submission

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

• Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions, Generic Drugs
• Guidance for Industry Preparation of Veterinary New Drug Submissions
• Guidance document: Preparation of regulatory activities in non-eCTD Format 
• Veterinary drugs: Management of regulatory submissions guidance

Contact us

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