New Drug Submission Process in Canada



In Canada, as in all countries with regulatory agencies, there are specific regulatory pathways and processes for health products to be authorized for use in clinical trials or to obtain marketing approval. This article will focus on what is called the New Drug Submission Process in Canada. If you are looking to conduct a clinical trial in Canada or submit for the marketing authorization of a new health product, it is important to be familiar with the new drug submission process in Canada and what other regulatory processes look like, including the pathways that are available to you to achieve this.

We will present the principal regulatory process for drug approval with Health Canada. The regulatory process for other health products, including Medical Devices, will be covered in subsequent articles.


Drug Regulatory affairs in Canada

Regulatory affairs in relation to clinical trials or investigational testing refers to the process of ensuring that a trial conducted with patients or healthy individuals adheres to all relevant laws and regulations during the drug, medical device, or other health product clinical development process. This includes getting necessary authorizations from regulatory agencies governing the country where the sponsors wish to launch a trial.

In Canada, that regulatory agency is Health Canada (HC). The goal of HC, its Food and Drug Regulations, and regulatory processes is to protect the health and safety of the participants in those trials and ensure the accuracy and integrity of the data collected; this includes the reporting of any serious adverse events that occur during the studies. HC is interested not only in the safety of trial participants; data accuracy and integrity are as important and are needed for the eventual market access application you will submit at the end of the clinical development process.

Most countries have their own regulating body, for example, the Food and Drug Administration (FDA) in the United States (US), European Medicines Agency (EMA) in the European Union, Therapeutic Goods Administration (TGA) in Australia and the Central Drugs Standard Control Organization (CDSCO) in India, to name a few.

What they have in common is that the approach to trials, drug development, and market access process be transparent and efficient whilst ensuring the safety, efficacy, and quality of the product for their citizens.


Regulatory and licensing pathways for drugs in Canada

In Canada, Health Canada has various licensing pathways for drugs, medical devices and other health products and they continue to work towards different pathways to facilitate market access of key health products, particularly those for unmet medical needs.

The regulatory strategies and submission work are done by regulatory experts; professionals well-versed and experienced in how each regulatory body evaluates and approves New Drug Submissions (NDS), Medical Devices License Applications as well as other health product applications in Canada or their equivalent outside Canada.

Specifically, the drug approval pathways in Canada are summarized as follows:

Regular New Drug Submission Process in Canada – NDS:

NDS stands for “New Drug Submission” in Canada, other acronyms would apply outside Canada. It is the regulatory process required by Health Canada that pharmaceutical companies are required to go through to bring their new drugs to the market. The submission must include all relevant data and information about the drug, including non-clinical, clinical, and quality data, which address safety and efficacy as well as the overall quality (chemistry, manufacturing, and controls) of that drug. Health Canada reviews this information to determine if the drug is of good quality, safe and effective (positive benefit vs. risk ratio) for its intended use. Only then can it be approved for sale to the public.

The standard timeframe for scientific review of the NDS is 300 days, preceded by a screening period of 45 days and 10 days of technical processing, as indicated below:


New Drug Submission Process in Canada


Priority Review New Drug Submission Process in Canada – PR NDS

A Priority Review (PR) New Drug Submission (NDS) is a type of regulatory filing submitted to Health Canada for the review of a new drug, at the end of its clinical development program, that is considered to have the potential to provide significant benefit over existing therapies (when available) for serious or life-threatening conditions. PR NDSs are prioritized over standard NDSs and are scientifically reviewed within 180 days, rather than the standard review time of 300 days. This expedited review process is intended to help bring new, innovative treatments to patients in need more quickly.

To apply for a Priority Review NDS, a sponsor must demonstrate that the drug is to be used for a serious, life-threatening, or severely debilitating condition when there is substantial evidence of clinical effectiveness that shows the following:

  • effective treatment, prevention or diagnosis of a disease, for which no therapy is available in Canada, or
  • significant increase of efficacy and/or decrease in risk, supporting an improved benefit/risk profile over available treatment, prevention, or diagnostic agent for a disease, not adequately managed by available agents in Canada.

In summary, Priority Review New Drug Submission Process in Canada allows for drugs with a complete clinical program that address important unmet medical needs. The sponsor has to apply for a PR through an official request supported by a Clinical Assessment Package, justifying scientifically and with sufficient data why the submission should be granted PR rather than following the standard NDS process.

The Priority Review process differs from the regular NDS process as presented below:

New Drug Submission Process in Canada with Priority Review

Notice of Compliance with Conditions – NOC/c NDS:

The Notice of Compliance with Conditions (NOC/c) pathway allows a sponsor to bring a new drug to market during the clinical development process, and therefore more quickly, in exchange for accepting to complete the clinical development program agreed to with Health Canada. An approval under the NOC/c policy contains conditions that a sponsor needs to comply with after the drug approval.


Eligibility for advanced consideration for a NOC/c applies to NDSs and SNDSs for serious, life-threatening, or severely debilitating conditions when there is promising evidence of clinical effectiveness based on the available data that shows the following:

  • effective treatment, prevention, or diagnosis of a disease, for which no therapy is available in Canada, or
  • significant increase of efficacy and/or decrease in risk, supporting an improved benefit/risk profile over available treatment, prevention, or diagnostic agent for a disease, not adequately managed by available agents in Canada.

NOC/cs are possible for drugs with promising clinical data that addresses important unmet medical needs. The NOC/c process differs from the regular NDS process as presented below:

New Drug Submission Process in Canada -NOC with Conditions

Drug Submissions Relying on Third-Party Data (Literature and Market Experience):

This refers to the use of existing scientific literature or third party published data in lieu of clinical study reports to support the safety and efficacy of a drug. Literature can be used to support a New Drug Submission (NDS) or a Supplemental New Drug Submissions (SNDS) in Canada.

This approach saves time and resources for both the sponsor and HC, provided that the submission complies with the criteria established by HC. The literature must be relevant, reliable, and adequate to support the safety and efficacy of the drug in question and meet current regulations, guidelines and recommendations. The chemistry, manufacturing and controls (quality) data requirements are the same as for any other NDSs or SNDSs.

In addition to the pathways summarized above, HC does explore additional pathways to facilitate drug development to address unmet medical needs and to streamline their own processes, for example: Australia-Canada-Singapore-Switzerland (ACSS) Consortium and use of foreign reviews and decisions.

Project Orbis is another example of an international partnership HC is a part of which is designed to give cancer patients faster access to promising cancer treatments, alongside the US FDA. Products eligible for Project Orbis include oncology products that are either new active substances or new indications for previously approved drugs. Project Orbis submissions are expected to meet the criteria for “FDA Priority Review” and Health Canada PR or NOC/c criteria.

The various programs or pathways presented above can be explored with the assistance of regulatory experts, when a sponsor wishes to obtain a marketing authorization for a new drug in Canada. The various submission types have to respect specific criteria established by HC, which further underscores the need to work with regulatory experts that can orient the sponsor towards the most relevant and efficient pathway to use.

After the Notice of Compliance – NOC

Once Health has reviewed the submission and determined that the drug is safe and effective for its population, they will issue a Notice of Compliance (NOC), which grants the sponsor permission to sell the drug in Canada.

After an NOC has been granted for a new drug in Canada, maintaining the drug on the market requires various compliance activities, including pharmacovigilance and lifecycle management to ensure that the drug continues to be compliant with the requirements of the Food and Drug Regulations. Life cycle management activities could include a Supplemental New Drug Submission with new data from clinical trials to support a new indication or other important changes to the labelling of the drug. Likewise, major changes to the manufacturing process, or adding new formulations or a new dosage form, for example, would also require a submission to HC to ensure compliance with the regulations. For major changes that require approval from HC, a new NOC will be issued once HC has reviewed the submission and supporting data and, determined that the changes are acceptable; only then these changes can be implemented.

The Role of Regulatory Experts

Whichever pathway you utilize, it is imperative that the approach be one that is streamlined, transparent, and efficient, while ensuring the quality, safety, and efficacy of the product. It is the role of regulatory experts to strategize with you about which pathway to follow, and to navigate these applications through HC or their equivalent outside of Canada, to liaise with regulatory body officials, and lead the submission process.



For further information about the drug review & approval process in Canada, or about the New Drug Submission Process with Health Canada or to have a complementary discussion about your needs, please contact SPharm directly.

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The Drug Review and Approval Process in Canada – An eGuide

The Drug Review and Approval Process in Canada - an eGuide


How are drugs reviewed and approved in Canada?

How are drugs reviewed in Canada is a question often asked. What follows is a summary of the Drug Review and Approval Process in Canada – an eGuide in accordance with the Food and Drugs Act (FDA), the Food and Drug Regulations (FDR), the related policies and Health Canada guidelines

For a drug, a biologic or a genetic therapy, a medical device, a combination product, a natural health product or other health product company seeking approval of their product for sale in Canada, it is important to understand that the approval process is subject to close scrutiny by the governing regulatory body.

However, the review process and preparing for that review process does not have to be complex, intimidating, nor frustrating. The key is to know, follow and/or clarify the process related to the health product of interest and ensure preparedness with proper data and documentation.


    Download this Guide Right Now!

    Download a PDF version of this guide.


    How are drugs reviewed and authorized for sale in Canada?

    Most health products, including drugs to be marketed or sold in Canada are reviewed and authorized by the Health Products and Food Branch (HPFB) of Health Canada, more precisely, under the Therapeutic Product Directorate (TPD) or the Biologic and Genetic Therapies Directorate (BGTD), for drugs and biologic, respectively. Each of these Directorates have specific offices and bureaus. Drugs are authorized to reach that market only once they have successfully gone through the relevant Bureau review process, responsible for assessing their safety, efficacy and quality, and, received a favorable decision. Even after a health product receives a favorable decision and can proceed with its sale in Canada, monitoring of its effectiveness and safety continues.

    What is Canada’s Health Products and Food Branch?

    Health Canada’s HPFB is the national authority that is responsible for regulating, evaluating, and monitoring the safety, efficacy, and quality of drugs, biologics, genetic therapies and other health products available for the Canadian marketplace. The HPFB’s mandate is to manage the health-related risks and benefits of health products and foods for Canadians.



    We have categorized the drug development process in 5 stages and have provided a graphic below to accompany the text.


    Researchers start by discovering and identifying various chemical, biological substances or other products on the way towards developing a drug. This can be done through new information regarding a disease process, many tests of molecular compounds to find possible beneficial effects, existing treatment that have unanticipated effect and new technologies. Once the researchers have identified a promising compound, they perform testing for activity, efficacy, toxicity and ultimately, gather preliminary information on its effectiveness and safety. This initial research can take a few years of experimentation. If the results are promising, researchers will proceed to the next step of development.

    A representation of the Drug Development Process is presented in the graphic below:



    The next step in development is where researchers administer the drug to selected species of animals (in vivo) or cells (in vitro). The drug must be shown to cause no serious harm (toxicity) at the doses required to have an effect. If results from these initial studies are promising and further tests show acceptable safety levels and clear or potential efficacy, then the next step would be to submit a Clinical Trial Application to the TPD or BGTD for authorization to allow human participation in a Canadian clinical trial.


    All drugs authorized to be marketed or sold in Canada must have been studied in clinical trials. The information gathered from these trials are then included in the relevant regulatory dossiers to be reviewed for the drug to be eventually authorized for sale in Canada by the HPFB, through its relevant Directorate. The results of clinical trials conducted in humans are key components of the review process by the HPFB. The purpose of a trial is to gather clinical information about a drug’s effectiveness, safety, determine best dosing/usage in humans, evaluate any adverse drug reactions and compare results to already existing treatments for the same disease or condition or, to placebo when no treatment already exists for the aimed pathology (when ethically possible).

    Clinical Development:
    If clinical trials have already been done in Canada and/or in other countries, that is, at the end of the clinical development plan, the sponsor may choose to file a New Drug Submission with the HPFB in order to gain authorization to market and sell the drug in Canada (see New Drug Submission process section below).

    However, when a sponsor aims to conduct a clinical trial in Canada, during the clinical development program, then a Clinical Trial Application (CTA) must be submitted to be reviewed and approved by the HPFB’s relevant Directorate in order to proceed with the trial. The results of these studies will be part of the drug approval process.

    What is the Clinical Trial Application?:
    The Canadian CTA dossier consists of the following documents (exceptions are possible): administrative form, protocol, protocol summary (Health Canada’s template), Informed Consent Form, Investigator’s Brochure and quality dossier summary (Health Canada’s template per study phase).

    Health Canada reviews the CTA and notifies the sponsor within 30 calendar days from the date that the application is considered complete. Questions may be issued during the review, and the sponsor will have 2 calendar days to provide the response (exceptions can apply). Note that CTAs are required for phases I to III clinical trials. The authorization (No Objection Letter) is mandatory prior to initiating the trial and importing the investigational product(s) in Canada.

    If the HPFB provides authorization, the study can be underway with human subjects that are informed and have given their consent to be administered the drug for their participation. Note that a Canadian Ethic Committee must also approve the study material (protocol, Investigator’s Brochure and Informed Consent Form). Tests are conducted in a controlled environment where drug administration procedures and results are closely tracked, monitored and analyzed.

    What are the Clinical Trial Phases?

    There are, in summary, four (4) phases in the clinical trials process. Each clinical trial phase for drugs has a different purpose.

    Phase 1 – The Safety phase
    This phase usually tests an investigational drug on a small group of healthy individuals for the first time (except when not ethically acceptable to do so). The purpose is to determine the pharmacokinetics/pharmacological action of the drugs, find a safe dosage range and identify adverse drug reactions.

    Phase 2 – The Effectiveness phase
    In this phase, the drug is given to a larger group of individuals with the pathology to be treated (usually several hundred). The purpose is to obtain data on the effectiveness of the drug, to further assess the drug’s safety and to determine the best dose.

    Phase 3 – The Confirmation Phase
    If the results from Phase 2 look promising, the drug manufacturer would proceed into Phase 3 trials. In this phase, the drug is given to even larger groups of patients (usually in the thousands). The purpose of this phase is to confirm the drug’s effectiveness, monitor side effects, compare the drug to other commonly used treatments and to collect further information that will allow the drug to be used and marketed safely.

    Phase 4 – The Monitoring phase
    Phase 4 trials are done after the drug is already approved and sold on the market. The purpose of this phase is to gather more information on the best ways to use a drug, and the long-term benefits and risks to the population. Unless agreed to with Health Canada, these studies do not need to be submitted under a Clinical Trial Application, when used according to the terms of the market approval.

    If the drug is to be used outside the terms of the market approval (that is in a different population, for a different indication, using a different dose, etc.), the study will not be considered a phase IV. Consequently, in these cases, a CTA will need to be submitted to Health Canada in order to obtain a No Objection Letter.



    What is New Drug Submission Health Canada (NDS)?
    If results of all the preclinical studies and the clinical trials show that a drug’s potential therapeutic benefit outweighs its risks (side effects, toxicity, etc.), and the chemistry and manufacturing dossier is complete, then the sponsor may decide to file an NDS with the appropriate HPFB Directorate in order to be granted authorization to sell the drug in Canada. A sponsor can submit an NDS whether the clinical trials were done in Canada or in other countries. The NDS must include the results of the quality (Chemistry and manufacturing), preclinical and clinical studies, whether done in Canada or in other countries.

    The drug’s efficacy and safety data is evaluated and the Risk/Benefit analysis is performed, before reaching a decision.

    The information requested by Health Canada as part of an NDS application must be detailed enough that Health Canada can make an assessment on the safety and effectiveness of the new drug. All submissions must be provided to Health Canada in an electronic Common Technical Document (eCTD) format.

    For a more complete look at NDS, please review our article on the New Drug Submission Health Canada Process

    What is a Common Technical Document?
    The CTD format originates from the International Conference on Harmonization (ICH) initiatives, in their effort to harmonize efficacy, safety and quality (chemistry and manufacturing) requirements globally for the registration of drugs (pharmaceuticals, biologicals, genetic therapies, …) for human use. This initiative includes standard information organization for new drug registration applications. The CTD format is divided into five modules: Module 1 contains region-specific information and Modules 2–5 contain common clinical, nonclinical and quality information with some regional variations.

    The CTD format is presented below.

    The Module 1 (regional) includes the following, amongst other information:

    • Administrative form
    • Product Monograph
    • Mock-up of Inner and Outer labels
    • Certified Product Information Document
    • Brand Name Analysis
    • Risk Management Plan
    • Etc

    What is an Abbreviated New Drug Submission (ANDS)?
    The ANDS regulation was created to make the approval process for generic drugs simpler and more cost effective. Under an ANDS, the manufacturer of a drug has to prove that its product is pharmaceutically equivalent and/and bioequivalent with the innovator’s drug. For the purpose of an ANDS the sponsor may need to perform a bioequivalence study or a physico-chemical comparison (parenteral drugs or drugs for which it is not ethical to conduct the study on healthy volunteer).

    Review Process
    The HPFB reviews the NDS and all the information about the drug captured during the development process (quality, preclinical and clinical) and evaluates the risks of the drug versus its benefits to the Canadian population. More specifically, HPFB reviews information regarding the drug’s manufacturing, packaging and labelling, as well as, information about the drug’s therapeutic claims and side effects. What Doctors and patients will be told about the drug will also be reviewed, through the drug’s monographs and information sheets. All drugs allowed to be sold in Canada are reviewed to ensure that they meet the requirements of the Food and Drugs Act and its Regulations. Once these requirements are met, the sponsor (usually the Marketing Authorization Holder) would receive a Notice of Compliance, confirming the dossier’s compliance with the Food and Drugs Act and its Regulations.

    How long does the Health Canada drug review process take?
    The target review timeline ranging from 7 months (accelerated review and ANDS) to 1 year (standard NDS). The exact time for Health Canada to review drug safety and efficacy information from an NDS depends on the type of drug, the quality of the dossier, the amount of questions that Health Canada raises during the review process, the answers provided by the sponsor and if the targeted timelines for the responses are respected. Once the review is complete, the Regulatory Agency decides to approve (or reject) the use of a new medication. In some instances, it can take longer than the targeted review timelines. HPFB review timelines are based on internationally competitive performance targets that are usually respected. By experience, the review can take anywhere from 6 months to 2 years, rarely more. The average time of the full drug development and approval process from initial research, preclinical studies, through the 3 phases of clinical trials to drug approval is 12 years (between 8 & 15 years).



    What is the Notice of Compliance from Health Canada?: Once the review is complete, if the conclusion is that the benefits of the drug outweigh the risks, that the risks can be managed and confirming the dossier’s compliance with the Food and Drugs Act and its Regulations, then the sponsor in Canada receives a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN), which is specific to a drug product to be sold on the Canadian market.

    What is a Notice of Non-Compliance from Health Canada? Upon the completion of the review process, if the HPFB finds that there is insufficient evidence to support the safety, efficacy or quality claims of the drug, HPFB will not grant a marketing authorization for that drug. At this point, the sponsor typically has 3 options: to supply additional information to the HPFB, to re-submit a submission at a later date with additional supporting data (without prejudice), or to ask that HPFB to reconsider its decision.

    What is an Accelerated Review Process from Health Canada?
    For health conditions that are serious, life-threatening or for a severely debilitating disease (such as Alzheimer’s disease, cancer, AIDS, or Parkinson’s Disease), the HPFB can provide faster authorization of a drug as follows:

    1. What is a Priority Review? (PR): Applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases.
    2. What is a Notice of Compliance with conditions? (NOC/c): Applies to drugs with promising evidence of clinical effectiveness throughout the clinical trial phases. Approval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s benefit and safety.

    To be considered for PR or NOC/c, the drug must meet the following standards as described by Health Canada; the drug must provide:

    • effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or
    • a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada


    Related to the NOC/c, some of the conditions of the Notice of Compliance include a requirement to closely monitor the drug for safety and to provide HPFB with regular updates. Once the conditions are met, the designation of “with condition” is removed from the NOC.



    Getting a Notice of Compliance from Health Canada isn’t the last step in the process of selling and marketing the drug in Canada. Once a health product is approved and, on the market, the HPFB requires a sponsor to ensure that the use of its drug is done under the terms of its market authorization. In addition, Life Cycle Management activities (post approval submissions to Health Canada, for new indications, new dosage forms, new strengths, manufacturing changes, etc.) are required to ensure the maintenance of the product License with its related improvements. In summary, sponsors need to ensure its continued compliance with the Food and Drug Regulations, while their products are on the market.

    On the other hand, Health Canada monitors drug information & adverse drug reactions reporting, conducts market surveillance, investigates complaints and manages recalls if necessary, amongst other things.

    There are also more processes and regulations to follow and consider, either before, during or after the review process, and before that drug is officially marketed, distributed and sold in Canada. Topics such as licensing, warehousing, wholesale distribution rules and the Drug Establishment Licence (DEL), regulations around distribution to consumers, regulations around the marketing and advertising activities, provincial requirements, health insurance funding rules, among others.

    All of these topics are worthy of their own article and are beyond the scope of this one.



    Health Canada is the federal body that regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations (FDR), its related policies and guidance. Before a drug can be distributed and sold in Canada, its manufacturer must receive a Notice of Compliance (NOC) from Health Canada, and the drug must be assigned a Drug Identification Number (DIN), uniquely identifying all drug products sold in a dosage form in Canada. New drugs must also go through extensive testing before being granted an NOC.

    It can take anywhere from 6 months to 2 years for Health Canada to review drug safety and efficacy information before providing a decision on whether an NOC is to be granted. Once granted, it represents that the drug meets the required standards under the Food and Drugs Act and its regulations, for use in humans. The monitoring for drug safety continues even once the drug finally makes it to consumers.

    The process of marketing and selling any new drug in Canada can certainly seem complex or intimidating. However, for drug companies seeking approval of their new drug in Canada, a number of strategies are recommended to make the process more effective. Focusing on preparedness, having proper data and documentation from research & trials and following proper guidelines are valuable recommendations to follow.

    Another recommendation is for drug companies or sponsors to work in collaboration with Canadian regulatory experts so as to optimize the registration process to ensure the best strategic registration initiatives, to anticipate the health authority’s potential concerns and to help in finding proactive solutions prior to submitting to Health Canada. Working with regulatory experts or consultants can help avoid unwanted review complications and delays and therefore, reduce cost consequences of potential market entry delays.

    Following the above recommendations will help turn a seemingly complex or intimidating Drug approval process into a more manageable and predictable one.



    For a more complete look at NDS, please review our article on the New Drug Submission Process

    For an infographic rendering of the above drug review and approval process in Canada, please click on the image below to have the option of downloading it in either PDF or JPEG version.

    For further information about the drug review & approval process in Canada, please contact Spharm directly.

    Drug Review and Approval Process in Canada - Infographic