In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be distributed in the Canadian market. Drugs include both prescription and non-prescription pharmaceuticals; biologically derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals.
Natural health products, such as vitamin and mineral supplements and herbal products for which therapeutic claims are made are also considered drugs at the level of the Food and Drugs Act; however, these products are regulated as natural health products under the Natural Health Products Regulations and not as drugs under the Food and Drug Regulations.
Health Canada will generally authorize a drug product after a drug review process to assess the safety, efficacy, and quality of a drug and if it is satisfied that:
- the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with the use of the therapeutic product; and
- the therapeutic product is suitable for its intended purpose and that any risk associated with its use is minimised, based on its formulation, manufacturing process controls, specifications, and shelf life, as well as its stability under the recommended storage conditions.
Steps to obtain authorization to develop, test, and/or market a drug product
It is important to quickly mention that “drug development” as a process of bringing a new drug molecule into clinical practice in its broadest definition encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug. However, before testing a drug in humans, scientists must test whether it has the potential to cause serious harm, also called toxicity via in vivo experiments, in vitro experiments, or both. If the results are promising – demonstrate acceptable safety levels and clear or potential efficacy, the team will proceed to the next step of development. This step requires an application to Health Products and Food Branch of Health Canada for authorization to conduct a clinical trial in Canada.
1. Clinical Trial Application (CTA): If the preclinical research indicates that a substance produces the desired result and is not toxic, the sponsor applies to Health Products and Food Branch (HPFB) of Health Canada to conduct a clinical trial in Canada. According to NIH, “clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment”.
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The Health Canada review team has 30 days to review a CTA from the date of receipt of a complete application in Health Canada. The application first undergoes a screening phase to ensure that all submission components have been provided. Once screened for acceptability, the application is processed for review and an acknowledgement letter is issued to the sponsor to indicate the start of the review period. Once review is completed, the application is either authorized (a No Objection Letter is issued) or rejected (a Not Satisfactory Notice is issued). It is worth noting that CTAs are required for only phases I to III clinical trials. Clinical trials involving marketed drugs where the investigation is to be conducted within the parameters of the authorized NOC or DIN application (Phase IV clinical trials) do not require a CTA.
2. New Drug Submission (NDS): If clinical trial studies prove that the drug has potential therapeutic value that outweighs the risks associated with its use (e.g. adverse effects, toxicity), the sponsor may choose to file a NDS with HPFB. The NDS must provide information and data about the drug’s safety, effectiveness and quality. And this includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects.
- Within the first 10 day after receiving the application, Health Canada will assign a control number to the submission and subject the application to a thorough screening to ensure that the correct application type has been selected, that the format, structure and attributes of electronic data submitted comply with the CTD format and specifications, and that the submitted dossier is complete. Where the HPFB identifies deficiencies in the dossier, it will send a query stating the same to the applicant and put in place a stop-clock, which ends when the HPFB receives a complete and satisfactory response.
- Upon acceptance of the application, the HPFB will begin its evaluation. Similarly, a stop-clock starts when the HPFB issues a query to the applicant and ends when a complete and satisfactory response is received. Where necessary, the HPFB may involve external evaluators (whose identities will be kept confidential), experts and advisory committees. The external evaluators and experts are contractually bound to protect information provided to them. In addition to evaluating the safety, efficacy and quality data to assess the potential benefits and risks of the drug, the review team evaluates the information that the sponsor proposes to provide to health care practitioners and consumers about the drug such as the label, product brochure and information sheets.
- Following the completion of the review, if the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada. Suffice to mention that following product registration, product registrants are responsible for ensuring the product’s quality, efficacy, and safety throughout its life cycle, and must notify Health Canada of any changes to the same.
- In instances where there is insufficient evidence to support the safety, efficacy or quality claims, HPFB will not grant a marketing authorization for the drug and a Notice of Non-Compliance (NON) will be issued to the sponsor. Meanwhile, the sponsor has the opportunity to supply additional information, to re-submit its submission at a later date with additional supporting data, or to ask that HPFB reconsider its decision.
- There are also instances when the application can be approved subject to adequate response to minor deficiencies. The HPFB will inform the applicant of the approval conditions (Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), and the applicant will need to satisfy these conditions within a specified time period.
- Although HPFB has set internationally competitive performance targets for its conduct of reviews, the review time depends on the product being submitted and the size and quality of the submission, as well as HPFB’s workload and human resources. Other factors include the number of questions that Health Canada raises during the review process, the answers provided by the sponsor and the clock-pauses. Nevertheless, the target review timeline ranges between 7 months (accelerated review and ANDS) to 1 year (standard NDS).
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What Are Clinical Trials and Studies? https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies
How Drugs are Reviewed in Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html
Guidance Document: The Management of Drug Submissions and Applications. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html#a90