Closed consultation on the draft guidance for preparing veterinary abbreviated new drug submissions: Clinical and human safety requirements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Health Canada was seeking feedback on a draft guidance document on the clinical and human safety requirements for the preparation of veterinary abbreviated new drug submissions (ANDS), more commonly referred to as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:
- 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