Closed consulation on the draft guidance for preparing veterinary drug submissions: Quality requirements

From Health Canada

Health Canada was seeking feedback on a draft guidance document on the technical quality requirements for the preparation of:

• veterinary new drug submissions (NDS), commonly referred to as new drugs
• abbreviated new drug submissions (ANDS), commonly referred to as generic drugs

This proposed guidance is an update of the quality requirements as outlined in the:

• Guidance for Industry: Preparation of Veterinary New Drug Submissions
• 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 quality requirements for new and generic drug submissions.

Proposed changes to the guidance document included:

• separating the quality requirements (that is, chemistry and manufacturing) for veterinary generic drugs from the clinical and human safety requirements
  • Guidance on clinical and human safety requirement for veterinary ANDS is also currently under consultation
• providing details on the quality requirements for both NDS and ANDS veterinary drug submissions in 1 new guidance document
• clarity on the quality submission requirements for veterinary new and generic drugs
• re-structured headings to align with Health Canada's human drug submission guidance
• a revised modular format for more user-friendly navigation

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

• quality requirements for veterinary NDS and ANDS
• appropriate supporting information for submissions

Once final, this guidance document would replace the quality requirements currently outlined in the:

• Guidance for Industry: Preparation of Veterinary New Drug Submissions
• 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