The Drug Approval Process in Canada

Medunik Canada makes new treatment options available to Canadians with rare diseases by building strategic partnerships with international companies to bring their orphan drug products to the Canadian market. But bringing these medications to Canada is not simply a matter of forming partnerships and securing licensing agreements. In fact, the process of bringing any new drug to the Canadian market is far more complex.

Health Canada's Health Products and Food Branch (HPFB) is the national authority responsible for regulating, evaluating and monitoring the safety, efficacy, and quality of drugs and medical devices for the Canadian market.

Before any drug can be sold on the Canadian market, it must go through a stringent drug review process conducted by Health Canada’s Health Products and Food Branch (HPFB). On occasion, external experts are also called upon to assess a particular drug’s safety, efficacy and quality.

For a drug company seeking to have a drug approved for sale in Canada, the review process can be long and expensive.

How long does the drug review process take?

The time it takes for the HPFB to complete the review process depends on the product being submitted, the scope and quality of the submission, the agency’s workload and its available human resources.

The following is a brief summary of the Canadian drug review process :

  1. The sponsor must test the new drug on animals for toxicity. Various species are used to gather basic information about the safety and efficacy of the compound being investigated.
  2. If these preclinical tests indicate that the substance produces the desired effect and is not toxic, the sponsor may submit a Clinical Trial Application to the HPFB, requesting authorization to conduct a clinical trial in Canada. The purpose of a clinical trial is to gather information about the drug's dosing, effectiveness and safety in humans.
  3. The HPFB reviews the Clinical Trial Application, which includes preclinical test results, production methods, dosage form and information about the investigators who will be conducting the study.
  4. Provided the HPFB authorizes the sponsor to proceed with a clinical trial, the trial is undertaken with informed and consenting human subjects in a controlled environment where drug administration and results evaluation procedures are closely monitored.
  5. If results of the clinical trial demonstrate that the drug’s potential therapeutic value outweighs the risks associated with its use (e.g. adverse side effects, toxicity), the sponsor may choose to file a New Drug Submission (NDS) with the HPFB. The NDS must contain information and data about the drug's safety and include the results of the preclinical and clinical studies, details regarding the drug’s manufacturing, packaging and labelling information, as well as information about the drug’s therapeutic claims and side effects.
  6. The HPFB performs a thorough review of the information submitted, occasionally in consultation with external consultants and advisory committees, and evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug. It also reviews the information that the sponsor proposes to provide to healthcare providers and consumers about the drug.
  7. Following the review, if the HPFB concludes that drug’s benefits outweigh its risks and that the risks can be mitigated, it officially approves the drug for sale in Canada by issuing a Notice of Compliance (NOC) and a Drug Identification Number (DIN). Note: All drugs granted marketing authorization in Canada are reviewed to ensure that they meet the requirements of the Food and Drugs Act.

    If the HPFB decides not to grant a marketing authorization, the drug’s sponsor has the option of providing additional information, re-submitting its submission at a later date with additional supporting data, or asking the HPFB to reconsider its decision.
  8. Once approved, Health Canada may continue to test certain products through its Lot Release Process to monitor their safety, efficacy and quality.

The distributor of the drug must report any new information it receives about serious side effects including the drug’s failure to produce the desired effects. It must also notify the HPFB about any studies that have provided new safety information and request approval for any major changes to the manufacturing processes, dosing or recommended uses for the drug.

HPFB conducts market surveillance, monitors adverse reaction reports, investigates complaints and problem reports, and manages recalls, should the need arise.

In addition, HPFB licenses most drug production sites and conducts regular inspections as a condition for licensing.

Priority Review Process

The HPFB’s Priority Review Process allows for faster review of promising drug products for life-threatening or severely debilitating conditions (e.g. cancer, AIDS, Parkinson's disease) for which there are few effective therapies already on the market.

Special Access Program

The HPFB’s Special Access Program allows physicians to gain access to drugs that are not currently available in Canada. Following approval by the Special Access Program, a physician may prescribe such drugs to specific patients, if it is the physician's belief that conventional therapies have failed or are inappropriate.
The drug is only authorized if the HPFB determines that the need is legitimate and that the requesting physician is qualified. The drug's manufacturer must also agree to release the product to the qualified physician.