Animals > Veterinary Biologics  

Veterinary Biologics

The Veterinary Biologic Section (VBS) of the Animal Health and Production Division, Canadian Food Inspection Agency (CFIA) is responsible for licensing veterinary biologics in Canada. This licensing program forms an integral part of Canada's National Animal Health Program which strives to protect the health of food producing animals, domestic pets, and the Canadian public by preventing the introduction and spread of certain important animal diseases.

To meet the requirements for licensure, veterinary biologics must be shown to be pure, potent, safe, and effective when used in the target species according to the manufacturer's label recommendations. In addition, the licensing submission must also contain supporting data demonstrating that the product can be manufactured and used without adversely affecting animal health, human health, food safety or the environment. [ more... ]

What is a veterinary biologic ...

Veterinary biologic means

a.   a helminth, protozoa or micro-organism,
b.   a substance or mixture of substances derived from animals, helminths, protozoa or micro-organisms, or
c.   a substance of synthetic origin

that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in animals. Veterinary biologics include vaccines, bacterins, bacterin-toxoids, immunoglobulin products, diagnostics kits, and any veterinary biologic derived through biotechnology.

Program

In Canada, veterinary biologics are regulated by the Veterinary Biologics Section (VBS), of the Animal Health and Production Division, Canadian Food Inspection Agency (CFIA), under the legislative authority of the Health of Animals Act and Regulations. Regulated products include vaccines, immunoglobulin products, and diagnostic kits that are used for the prevention, treatment or diagnosis of diseases in animals including domestic livestock, poultry, pets, wildlife, and fish. Veterinary biologics are licensed on the basis of fulfilment of four criteria: purity, potency, safety and efficacy. A risk-based approach is used to evaluate the safety of the product in target species, as well as non-target species, humans and the environment.

The Health of Animals Regulations include specific provisions authorizing CFIA to regulate the release of novel organisms (such as live recombinant veterinary biologics) into the environment. This will require researchers to notify CFIA, and to obtain a permit authorizing the release or the field testing of a veterinary biologic. All veterinary biologics containing modified live organisms, including genetically modified organisms, are subject to these requirements

Purity means quality of a biologic prepared to a final form (i.e. freedom from extraneous micro-organisms and material, as determined by established test methods) which are documented in the approved production outline*.

Potency is a measure of the relative strength of a biologic when tested by established methods which are documented in the production outline. It should correlate to the immunogenicity / efficacy of the biologic.

Safety means the freedom from properties causing undue local or systemic reactions, when used as recommended.

Efficacy is a measure of the specific protective capacity of the biologic when used according to label recommendations.

* The production outline (or outline of production) is a detailed description of the manufacturing process, the methods and procedures used to handle, store, and administer the veterinary biologic, and the tests and test results used to establish its purity, potency, safety, and efficacy.

Services

Registration of veterinary biologics

• Licensing of veterinary biologics manufacturing facilities.
• Licensing of veterinary biologics.
• Issuance of import permits to Canadian importers of veterinary biologics.
• Issuance of export certificates to Canadian exporters of veterinary biologics.

Post-licensure monitoring

• Serial release.
• Investigations of consumer complaints related to a veterinary biologic.
• Inspection of manufacturers and Canadian importers of veterinary biologics.

Quality assurance monitoring by the Biologics Evaluation Laboratory (BEL) Centre of Expertise

• Post-licensure serial release monitoring of veterinary biologics for purity, potency, and safety.
• Verification of master seeds and pre-licensure product evaluation.
• Scientific advice in support of the regulatory program.
• Technology development, including collaborative research with industry partners.