As part of its Regulatory Roadmap for Health Products and Food initiative, Health Canada is working on the modernization of Canada's regulatory system for pharmaceuticals, including veterinary drugs.
The regulation of veterinary drugs is an important activity that supports the health and well-being of animals and the safety of Canada's food supply. Over the years, significant progress has been made in the management of the veterinary drugs program and stakeholder feedback has underlined support for a modernized regulatory regime for veterinary drugs. A dedicated regulatory framework for veterinary drugs would accommodate the unique differences of regulating veterinary drugs throughout their life-cycle across a variety of animal species, and in relation to oversight for the safety of the food supply. Such a regulatory framework should enable proportional and efficient approach to authorization of veterinary drugs while maintaining human and animal health safety standards including safety of the food supply throughout the product life cycle.
The key features of the proposed regulatory framework include:
Health Canada will hold two sessions of technical discussions with stakeholders on proposed approaches for veterinary drug regulatory modernization.
The two sessions will be held at the RA Centre in Ottawa on the following dates:
Session 1 - January 29-30, 2013
Session 2 - March 21-22, 2013
These technical discussions will serve as a forum to bring together a cross-section of stakeholders, including veterinarians, manufacturers, public health officials, livestock producers, and end users, to discuss the options proposed by Health Canada and provide input to inform the development of the proposed regulations. It is also the intent of these technical discussions to identify areas that need further policy work and to understand how stakeholders can contribute to the regulatory development initiative. Feedback received through the technical discussion sessions and ongoing engagement of stakeholders will be used in developing the regulatory proposal while providing Health Canada with an understanding of the practical effects of the proposed regulatory approaches.
Four days of discussions will cover the regulatory lifecycle of veterinary drugs, including specific areas such as restricted market authorizations, advertising, minor use minor species, and oversight on importation.
After introduction of the topic by Health Canada regulatory staff, stakeholders will have the opportunity to provide comments on the proposed approaches and make suggestions for improvement.
Participants were selected to represent the perspective of the regulator, manufacturers, veterinarians, public health officials, livestock producers, academics, end users as well as other government departments.
A series of technical discussion documents was prepared on each topic item for discussion with stakeholders. The scope of the technical discussion will cover drugs (i.e. as defined in the Food and Drugs Act) for veterinary use. The objective of these documents is to provide for purposes of discussion a model regarding regulatory requirements that would apply, for instance, to pre-market and post-market authorizations of veterinary drugs. Each technical discussion document includes a general overview of the topic and objectives, and elaborates on relevant items for discussion. To request any of these documents, please contact the Veterinary Drugs Directorate.
Topic A - Framework Introduction, Scope and Structure
Topic B - Application for Market Authorizations
Topic C - Application for Registration
Topic D - Post Market Authorization Obligations
Topic E - Restricted Market Authorizations
Topic F - Good Manufacturing Practices and Establishment Licenses
Topic G - Oversight on Importation
Topic H - Post Market Interventions
Topic I - Advertising & Data Protection
Topic J - Inspection / Compliance & Enforcement
Topic K - Minor Use, Minor Species
Topic L - Environmental Assessments
Topic M - Other Considerations
Stakeholder feedback received from the two technical discussion sessions will inform future development of regulations for veterinary drugs.
Health Canada will continue to engage stakeholders, international partners and the public. This work will proceed through the Canada Gazette process, where all parties will have the opportunity to consider and comment on proposed regulations.