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 All About Clinical Trials A Highly Regulated Process
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Un chercheur travaille dans un laboratoire.
Un chercheur travaille dans un laboratoire.
All About Clinical Trials

A Highly Regulated Process

The Oversight Process for the Development of a Health Innovation

The development of a new drug or any health innovation, from laboratory design to use by the public, is a highly regulated process that follows strict rules.

Different provincial, national and international regulations govern, in turn, how clinical trials are authorized, conducted and completed. If the results of the clinical trials are positive, federal and provincial authorizations are also required to make the new treatment available to the public.

Health institutions and ethics boards, in collaboration with Health Canada, evaluate the research project to validate its compliance.

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Click each step below to learn more about the oversight process for the development of a new drug
Basic Research
Preclinical Research
Clinical Research
Federal Review (Health Canada)
Provincial Review (INESSS, MSSS)
Drug Approval and Access

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Basic Research

2 to 3 years

In basic research, researchers study a number of molecules that can possibly become promising drugs.

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Preclinical Research

2 to 3 years

In preclinical research, researchers test the efficacy and safety of a potential drug based on the results of basic research, by conducting preclinical trials on animal or human cells (in vitro), or on laboratory animals (in vivo). This step is essential before tests can be conducted on humans (clinical research).

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Clinical Research

5 to 7 years

Before each clinical trial starts, it is analyzed at the scientific, ethical and legal levels to obtain approval from a research ethics board and scientific experts, as well as from Health Canada.

Health Canada is the federal agency that regulates and supervises clinical research.

Health Canada has an active role in:

  • protecting the rights and safety of the public
  • assessing data validity and integrity
  • ensuring compliance with the Food and Drugs Act and the Food and Drug Regulations, including good clinical practices
Phase I

Used to assess the safety and find the maximum tolerated dose of the study drug (15 to 30 people)

Phase II

Used to test the efficacy of the study drug and its side effects (about 100 people)

Phase III

Used to confirm the efficacy and safety of the study drug by comparing it to a placebo or standard treatment (100 to several thousand people)

Each clinical trial is monitored continuously by an independent data monitoring committee (IDMC) to ensure participants’ safety.

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Federal Review (Health Canada)

6 months to 2 years

If the results of clinical trials show that the drug is promising, the manufacturer can apply to Health Canada for authorization to make the drug available to the public.

Health Canada can take 6 months to 2 years to review the results of clinical trials. If the results are satisfactory, Health Canada issues a Notice of Compliance and a Drug Identification Number (DIN) authorizing the prescription of the new drug in Canada.

If the results are not satisfactory, the drug will not be authorized for sale in Canada.

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Provincial Review (INESSS, MSSS)

6 months to 2 years

Institut national d’excellence en santé et en services sociaux (INESSS) analyzes the overall value of the drug (clinical benefits, economic value, and so on).

INESSS then sends its recommendations to the Minister of Health and Social Services, who determines the conditions under which the new drug will be available to the public via Régie de l’assurance maladie du Québec (RAMQ).

If the recommendation is negative, the drug will not be covered by RAMQ.

There are also three exceptions for requesting access to drugs that are not yet authorized in Canada:

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Drug Approval and Access

Variable

Once the drug is available to the public, it is monitored while in use. During this period, studies can sometimes be conducted to assess its safety, side effects and efficacy under the actual conditions of use. We are talking about Phase IV clinical trials.

Health Canada can suspend or cancel the market authorization of the drug if there is a reasonable doubt that the drug poses a risk to the health of individuals.

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Clinical trials are conducted under a closely supervised protocol and follow a highly regulated process.

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Call us to find a clinical trial

514 669-6800 1 866 669-6814 (toll-free)
Or search Quebec’s Public Clinical Trials Database