Veterinary Biologics Guideline 4.10E
The Regulation of Veterinary Biologics in Canada
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The Canadian Food Inspection Agency's Canadian Centre for Veterinary Biologics is responsible for regulating the manufacturing, importation, testing, distribution, and use of veterinary biologics in Canada. The Canadian Centre for Veterinary Biologics's regulatory controls and standards are implemented under the authority of the Health of Animals Act and Regulations. These veterinary biologics regulations cover a diverse range of products such as vaccines, antibody products, and diagnostic kits which are used for the diagnosis, prevention, control, or treatment of a wide range of infectious diseases of animals. These products are derived from materials of animal or microbial origin, and may be produced by conventional microbiological methods or by modern techniques of biotechnology.
To meet Canadian licensing requirements, the regulated veterinary biologics must be shown to be pure, potent, safe and effective when used according to the manufacturer's label recommendations. The objective of this regulatory program is to help protect the health of Canadian animals (including domestic livestock, poultry, companion animals, wildlife, and aquatic species) as well as helping to safeguard public health and food safety by controlling indigenous animal diseases and preventing the introduction and dissemination of foreign animal diseases.
To license a veterinary biologic for sale in Canada, the Canadian or foreign manufacturer must provide research data and manufacturing and testing documentation to demonstrate the purity, potency, safety, and efficacy of the product, and support label claims. The Canadian licensing requirements for veterinary biologics are summarized in the document "Summary of Requirements and Guidelines for Veterinary Biologics in Canada" as well as the guidelines and forms which are available on the CFIA web site.
The licensing, policy development and inspection activities of the Canadian Centre for Veterinary Biologics are supported by CFIA field operations personnel responsible for activities such as importer facility inspections, and the Biologics Evaluation Laboratory (BEL), which conducts assays on veterinary biological products to help assure their purity, potency and safety.
The BEL provides quality assurance monitoring by performing pre-license testing, post-license quality control monitoring, test development and provision of scientific advice to the Veterinary Biologics program. Pre-license testing includes assays on master seeds and master cell stocks for purity and identity for both conventional and genetically engineered products. Initial testing of final product is usually carried out on the first three pre-license serials to assure the quality of the product and its consistency of production. For licensed products, randomly selected representative samples of product serials (other than those serial released by the United States Department of Agriculture Center for Veterinary Biologics) are tested as part of an ongoing quality control monitoring program. The laboratory participates in ongoing initiatives intended to harmonize the testing and regulatory requirements for the registration of veterinary biologics world wide.
Canadian veterinary biologics manufacturing facilities are licensed through issuance of a CFIA Veterinary Biologics Establishment Licence and a corresponding CFIA Veterinary Biologics Product Licence which lists the manufacturers' licensed products and the pertinent conditions and restrictions. Foreign manufacturing facilities are similarly regulated through issuance of a CFIA Permit to Import Veterinary Biologics to designated Canadian importers, who must import the product directly from the manufacturers' premises. The import permit lists the licensed products and pertinent conditions and restrictions, in a format analogous to the CFIA Veterinary Biologics Product Licence.
To obtain a Veterinary Biologics Establishment Licence, the manufacturer must demonstrate that the facilities and manufacturing procedures meet CFIA standards for manufacturing, testing, labelling, storage, and distribution of veterinary biologics. These requirements are outlined in the Health of Animals Act and Regulations and associated CFIA Veterinary Biologics Guidelines.
Manufacturers are required to implement appropriate internal controls and quality assurance monitoring processes to assure the safety and uniformity of their licensed products. These processes are regulated through approval of the manufacturer's production outline and labels by the Veterinary Biologics Section. Manufacturers and importers are inspected periodically to verify their conformance with these standards. To demonstrate the consistency of their manufacturing processes, manufacturers are required to submit summary test results for pre-licensing serials (batches). In addition, once a product has been licensed, Canadian manufacturers must obtain approval for the release of each serial on an ongoing basis. This serial release process entails submitting the manufacturer's summary test results, which are assessed by the Canadian Centre for Veterinary Biologics. At the time the serial release documents are submitted, the Canadian manufacturer also submits product samples to the CFIA Biologics Evaluation Laboratory, which may be selected for random confirmatory testing. These serial release controls and random testing requirements may also be implemented for those foreign manufacturers which are not subject to equivalent controls in the country where the product is manufactured.
In addition to the licensing of veterinary biologics for commercial sale in Canada, the Veterinary Biologics Section is also responsible for review and approval of applications for "restricted use" of veterinary biologics in special situations where an appropriate licensed veterinary biologic is not available. This is done through issuance of a Veterinary Biologics Product Licence, Import Permit, or Permit To Release Veterinary Biologics in which various restrictions and conditions are applied, depending on the nature of the product, country of origin, target species, intended use (i.e., investigational, educational, or emergency purposes), and the associated risks.
The advertising of veterinary biologics is controlled under the Health of Animals Act and Regulations. To conform with the regulations and the associated guidelines for advertising veterinary biologics, advertisements for veterinary biologics must not make any representation that is false, misleading or deceptive or that is likely to create an erroneous impression regarding the character, value, quality, composition, merit or safety of the advertised product.
Under the Health of Animals Regulations, manufacturers and importers are required to notify the Canadian Centre for Veterinary Biologics of suspected adverse reactions. Individual animal owners or veterinarians may report suspected adverse reactions by submitting the notification forms through the Canadian licensee, or they may be forwarded directly to the Canadian Centre for Veterinary Biologics. Upon receipt of these reports, the CCVB will instruct the affected manufacturer(s) or importer to investigate. If problems are encountered with a product or serial (batch), the manufacturer may be required to undertake corrective actions such as withdrawal of a product or serial from the Canadian market, modifications of the product formulation, or revision of the label directions and precautions. Veterinarians or owners observing any adverse reactions after the use of a licensed veterinary biologic are encouraged to report these incidents.
Further information about the CFIA's veterinary biologics regulatory program is available on the website. Enquiries may be obtained from the Canadian Centre for Veterinary Biologics.
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