Clinical Trial Application Process Myths

Clinical Trial Application Myths

Canada has become an increasingly popular destination for clinical trials over the years. Despite that, misconceptions persist about everything from approval time to the language used in the approval process. We are presenting six of the more common myths about clinical trial applications in Canada and the facts actually are. Which ones have you believed?

 

Myth # 1: Obtaining approval for clinical trials takes more time in Canada than elsewhere.

Reality: You’ll receive your approval (No Objection Letter) — or rejection — in 30 days. Once a Clinical Trial Application (CTA) has been submitted, questions can be raised by Health Canada to which an answer (with or without commitment) needs to be provided within 2 days. Once the CTA review is complete, Health Canada notifies the sponsor if the application is found to be acceptable or not. If the CTA is acceptable, Health Canada issues a No Objection Letter (NOL) within the standard 30-day review period; this NOL needs to be received before moving forward with the trial and will be needed for investigational drug importation purpose.

Compare that to the U.S., where the FDA has 30 days to determine whether a clinical hold is necessary or if the clinical trial can start. There is no specific duration for a clinical hold in the U.S..  There is no such hold in Canada.

In most european countries in Europe the target review timeline is 60 days but it often takes more than that to obtain a decision at the national level. EMA is looking into applying  a centralized procedure that will have a longer review period than 60 days.

 

Myth #2: The requirements for a Clinical Trial Application in Canada are more onerous than elsewhere.

Reality: The content requirements are actually less onerous than in the U.S.  and in the EU. No non-clinical or clinical study reports are required to be submitted within the CTA in Canada. What is needed are the administrative documents plus key scientific documents on which Health Canada bases their review on: the protocol, the informed consent form and the investigator’s brochure, in addition to the standard chemistry and manufacturing data. The Clinical Trial Application is composed of three modules:

  • Module 1 – contains administrative and clinical information about the proposed trial
  • Module 2 – contains quality (chemistry and manufacturing) information about the drug
  • Module 3 – contains additional supporting quality information, when needed.

There can be delays in initiating Clinical Trials in Canada, as in other jurisdictions. For instance, there may be delays in obtaining Research Ethics Board reviews and approvals (a decision independent from Health Canada). Also, sponsors and CROs in North America can prioritize the U.S. sites ahead of Canadian sites for many reasons including patient population (see myth no. 3). Typically, for global studies it can take a few months to get a site up and running in Canada.

Note that there are a number of effective clinical trial application experts in Canada that help with streamlining the clinical study start-up processes in parallel or after the clinical trials application approval. Contact SPharm to discuss your requirements.

 

Myth #3: Because of its population size, recruitment and enrollment are difficult in Canada.

Reality: Enrollment — recruitment and retention — is no more of a challenge in Canada than elsewhere. In fact, the average time from trial set up to first patient visit is three months, with 98 percent of subjects enrolled within the planned study period, according to the Canadian Clinical Trials Coordinating Centre (CCTCC).  One reason for this success is that Canada’s universal healthcare system means coordinated access to patients and better patient data.

Moreover, Canadians are highly educated and interested in research:  More than 70 percent of the population has expressed interest in participating in clinical research, according to the CCTCC.

Finally, as one of the most diverse nations in the world, Canada provides researchers with a broad pool of potential subjects.

 

Myth #4: All study documents must be provided in English and French.

Reality: Either language is accepted; for regulatory submissions, English is used more often. There are two exceptions: Labels and informed consent forms must be in both languages. Of course, all patient materials for trials in Quebec must be translated into French.

 

Myth #5: Drug trials in Canada cost more.

Reality: Canada has the second lowest cost among G7 nations in the management, design and coordination of clinical trials. Only France is cheaper, according to the Canadian Clinical Trials Coordinating Centre. Canada has one of the most attractive tax environments for research and development compared to the U.S. and other G7 countries.

 

Myth #6: The Clinical Trial sponsor needs a Canadian presence.

Reality: The Clinical Trial Application must be signed by a scientific or medical officer residing in Canada. Generally, the regulatory agent or the CRO can sign on behalf of the sponsor.

Are separate Clinical Trial Applications required for each protocol?

Is a separate Clinical Trial Application required for each protocol?

 

Presently, drug developers may submit more than one protocol into one single clinical trial application (CTA), when the Application is submitted to the Therapeutic Drug Directorate (TPD). Each protocol would then be considered a different dossier with a different control number per protocol; an approval per protocol would apply. When the CTA is submitted to the Biologic and Genetic Therapies Directorate (BGTD), one protocol only can be submitted per CTA. The upcoming electronic submission requirements for the CTA will likely impose the submission of one protocol per CTA for both Directorates.

Even with these differences, globally the process is quite similar in the US and Canada, however, the terminology used is different and this can cause some confusion.

In the U.S., we see one IND per product under clinical development, which is open to adding new protocol amendments etc… Clinical holds can apply to these INDs and the duration of the holds may vary. In Canada, there is a clinical trial application process, whereby one or more protocols can be submitted at once. New protocols are submitted as new CTAs. There are amendments and notifications that can be brought to clinical trial applications that are approved.

An amendment is considered a major change to an approved protocol or quality dossier, and therefore requires the same 30-day default review period. Minor changes are submitted as notifications within 15 days of the implementation of the change and no review period applies. Now, as mentioned, a new protocol must be submitted via a new clinical trial application. However, cross-referencing to an approved clinical trial application already on file for sections that are not changed, is possible. For example, cross-referencing to an approved investigator’s brochure or to an approved quality dossier. Therefore, it reduces the submission requirement and content. The process is simple and very similar to an IND amendment in the U.S., even if it’s classified as a clinical trial application in Canada.

 

The Drug Review Process

Drug Review Process

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.

 

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    How are drugs reviewed and authorized for sale?

    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.

     

    THE DRUG DEVELOPMENT PROCESS

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

    STAGE 1: INITIAL DRUG RESEARCH

    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:

     

    STAGE 2: PRE-CLINICAL STUDIES 

    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.

    STAGE 3: CLINICAL TRIALS 

    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.

    Clinical Trial Applications:
    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.

    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.

     

    STAGE 4: APPROVAL PROCESS

    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.

     

    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

    Abbreviated New Drug Submission
    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 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).

     

    NEW DRUG APPROVAL  DECISION

    Notice of Compliance

    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.

    Notice of Non-Compliance

    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.

    Priority Review or Accelerated Review Process

    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. Priority Review : Applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases.
    2. Notice of Compliance with conditions : 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.

     

    STAGE 5: AFTER  APPROVAL

    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.

     

    SUMMARY

    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.

     

    INFOGRAPHIC 

    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

    Drug Review Process in Canada – An Infographic

    THE DRUG REVIEW  PROCESS IN CANADA
    AN INFOGRAPHIC

     

    DOWNLOAD JPEG VERSION HERE
    DOWNLOAD PDF VERSION HERE

    Drug Review and Approval Process in Canada

    For further information about the drug review & approval process in Canada, please visit our FAQ section or contact SPharm directly.

    Has Regulatory Affairs in Canada changed from a decade ago?

    How has Regulatory Affairs in Canada changed from a decade ago?

     

     

    HOW HAS THE EVOLUTION OF REGULATORY AFFAIRS AFFECTED THE WAY CLINICAL TRIALS ARE CONDUCTED NOW VERSUS 10 YEARS AGO?

    With regards to clinical trial applications, Health Canada’s requirements have not changed much. However, they’ve had no choice but to open up to new strategies – novel agents, personalized medicines, or orphan drugs for which there is no official designation yet – and accept novel trial designs. Health Canada is very open to hear how novel therapies can help Canadians and there’s a clear openness and opportunity for collaboration.

     

     

    For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

     

    The importance of working with Canadian Regulatory Consultants

    The Importance of working with Canadian regulatory experts.

     

    WHY IS IT IMPORTANT TO WORK WITH EXPERTS IN CANADIAN REGULATORY AFFAIRS?

    Having a Canadian regulatory expert is important to facilitate the global Canadian submission process and all post-approval activities. It’s also important to know that Health Canada prefers speaking with individuals that understand the Canadian medical as well as regulatory environment, whether they are the sponsors or their representatives. The support of a Canadian regulatory consultant is key for the submission of clinical trial applications, New Drug Submissions, or other regulatory initiatives. But it is most important for the global product development strategy, particularly when dealing with niche products used for treating orphan or life-threatening diseases. By understanding Canadian as well as foreign regulatory environments, a Canadian consultant can provide the best strategic initiative for timely access to the Canadian market, keeping the global regulatory initiatives in mind.

    The regulatory paths for market access in Canada are essentially threefold. First there is the standard regulatory new drug submission path, then there is the notice of compliance with conditions (NOC/c) path, usually applicable for oncology or other niche products, and finally there is the priority review path. The latest two have shorter review standards at Health Canada.

     

     

    For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

     

    Why does Health Canada ask for Foreign Reviews?

    Why does Health Canada ask for Foreign Reviews?

     

     

     

    WHY IS IT THAT HEALTH CANADA ASKS FOR FOREIGN REVIEWS?

    The provision of foreign review reports in an NDS is not mandatory, but highly recommended. Indeed, they are usually requested at screening if not included within the original submission.

    In addition, within the Screening Acceptance letter, Health Canada usually requests the sponsor to share the Questions from foreign regulatory agency reviews and the sponsor’s answers, during the review of the NDS.

    In my experience and through my discussions with Health Canada, when the Canadian agency has questions that have already been addressed in a response to questions from a foreign agency, it likely reduces the number of questions to be raised to the sponsor, accordingly.

     

    For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

    Clinical Trial Site Information Forms – a Health Canada update

     

    Update: Clinical Trial Site Information Forms (CTSIFs)

    We recently communicated with our clients and partners about the recent changes Health Canada has made regarding the electronic submission of Clinical Trial Site Information Forms (CTSIFs), and we share them now with you.

    First is a reminder that CTSIFs must be provided to Health Canada prior to commencement of the trial.

    The new CTSIF is already available for submissions and will be mandatory as of January 2nd, 2020. The current form will not be accepted after that date.

    3 changes:

    There are 3 changes to be aware of in the new form and for online submissions:

    1. Drug Product and Sponsor information sections have been removed, as they are already found with the Clinical Trial Application.
    2. Previous versions of a completed form can be used to make revisions and it will be possible to identify precisely which sections of the form are revised.
    3. ‘Submit’ buttons on the form allow for direct electronic filing to Health Canada. An application control number is required prior to submitting a CTSIF, so that Health Canada can make the necessary link between the application and relevant CTSIFs.

    Have questions?

    Want to walk through the changes specifically for your trials? The experts at SPharm are available to discuss your needs.

    What type of Market Protection exists for new Drugs in Canada?

    What type of Market Protection exists for new Drugs in Canada?

     

     

    WHAT TYPE OF MARKET PROTECTION IS APPLICABLE IN CANADA AND HOW DOES IT APPLY?

    All drug products containing a new chemical entity are eligible to an eight-year period of market exclusivity. Should the drug product be aimed for a pediatric population, a further six-month extension can apply if the acceptable pediatric data are submitted within the first 5 years of the 8-year period. Health Canada will conduct a preliminary assessment while the drug is under review (NDS) and the sponsor will be notified of the outcome.

    Consequently, a subsequent-entry manufacturer is not allowed to file a submission for a generic drug for the first six years of the eight-year period. For products with eligible patents, submission of patent forms within the planned NDS and SNDS is critical to avoid loss of rights and generic entries to the market earlier than the market allows.

     

     

     

    For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

     

    Will Health Canada approve Trials with multiple investigational products?

    Will Health Canada approve Clinical Trials designed with more than one investigational product?

     

    WILL HEALTH CANADA APPROVE CLINICAL TRIALS DESIGNED WITH MORE THAN ONE INVESTIGATIONAL PRODUCT?

    Yes, definitely. With the appropriate quality information for both investigational products, Health Canada will review the dossier and approve it if it meets the Canadian requirements, and that will be under the same 30-day default review period.

     

    For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.