How Do I File a Submission? The Approval Process for New Veterinary Drugs

This content was archived on June 24, 2013.

When is Approval Given?

Veterinary drugs are used to prevent and treat diseases in animals caused by micro-organisms and parasites. Some drugs may help to promote growth, control reproduction or provide humane means of restraint and relief of pain in animals. A new veterinary drug is approved for sale in Canada only if Health Canada is satisfied that:

• the drug is safe for the animals to be treated and effective for the purpose it is being marketed;
• it does not leave potentially harmful residues that could pose any health hazard to humans eating food products from treated animals (meat, milk, eggs, fish and honey);
• the drug must be manufactured according to strict specifications and must remain stable up to its expiry date.

Review of new veterinary drugs is conducted by the Health Products and Food Branch's Veterinary Drugs Program, through the work of the Veterinary Drugs Directorate.

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The Drug Review Process

The review of a veterinary drug is the same as for any drug, whether produced by traditional methods or by biotechnological means. It must undergo rigorous scrutiny and fully satisfy all scientific requirements under the Regulations to the Food and Drugs Act. Non-scientific issues, such as social and economic matters, are not part of the scientific review. For a new drug to be reviewed, the manufacturer must:

• submit a New Drug Submission which contains details of manufacturing and quality control as well as results of toxicity, pharmacology, residue and clinical studies;
• furnish the Directorate with substantial evidence to support the product's quality, safety and efficacy;
• prove the proposed labels for the new drug reflect the data submitted and specify adequate directions for use, including withdrawal periods for drugs used in food-producing animals.

Manufacturers must also submit information, in a Supplemental New Drug Submission, if they wish to make significant manufacturing changes or modify conditions of use (labelling) for previously approved drugs.

If required, the Directorate will ask for further information. This process continues until the Directorate rejects the application or approves it.

Scientists in the Veterinary Drugs Directorate review the claims and findings of a company in the submissions and ensure that the information that will be provided to veterinarians and the consumers is clear and unequivocal.

When there is a lack of consensus among its scientists, or when the Directorate would benefit from outside advice, it will also convene an Expert Advisory Panel to review data and recommendations made by scientists.

Following the review of all existing data which could also include an Expert Panel review, the scientists who have evaluated the submission, assess the risks and benefits and make recommendations to their supervisors to either accept or reject the submission. The Head of the Veterinary Drugs Programs, taking into account the recommendations of the scientists and scientifically-trained managers, rejects or accepts the submission.

If a submission is accepted and the product is approved, the manufacturer will receive a Notice of Compliance from Health Canada specifying the terms and conditions under which the drug can be sold and used. The drug must bear a Drug Identification Number (DIN) on its label.

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Drugs for Investigational, Experimental or Emergency Use

Manufacturers may be authorized to sell Investigational New Drugs to qualified investigators for the purpose of conducting clinical evaluations, and the Directorate may issue Experimental Studies Certificates to researchers to carry out specific projects. However, there must be adequate evidence that the drug is safe for use in the animals to be treated and poses no demonstrable human health risk from the consumption of food derived from treated animals. A detailed experimental protocol must be submitted for evaluation prior to the issuance of such certificates.

Emergency Drug Releases may be issued by the Directorate to authorize the sale of limited quantities of drugs which are not approved for sale in Canada to veterinarians for emergency use. Adequate evidence is required that the drug poses no known health risk to the animals to be treated or to consumers. The veterinarian assumes full responsibility for the drug's efficacy, the safety of treated animals and for any drug residue violations.

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Confidentiality of Data

All information provided by manufacturers is treated with confidentiality under the Access to Information Act.