Drug Approval Process
is responsible for ensuring that all drugs used by the public are safe and effective. The branch within Health Canada that is responsible for this is the Therapeutic Products Directorate (TPD)
under the management of the Health Products and Food Branch of Health Canada
. All drugs marketed in Canada must meet the requirements of the Food and Drugs Act
Before approval, a drug must be rigorously tested to ensure its safety and effectiveness. The average time for developing and marketing a drug from initial laboratory tests to sale of a drug is 12 years
. Health Canada follows a set of performance targets for its conduct of reviews to ensure international competitiveness. Health Canada also has a Priority Review Process in place which allows for faster reviews of promising drugs meant to treat life-threatening or severely debilitating conditions.
Laboratory tests are carried out using tissue cultures and small animals. If positive results are seen and no harm comes to the animals, then the researchers can apply to the TPD for permission to conduct clinical trials on humans. The researcher must apply and receive permission from the TPD to advance to any phase of clinical trials.
There are three stages for clinical trials described as phase 1, phase 2 and phase 3. Trials involve human research participants who are fully informed as to the purpose of the research and potential risks and who give their informed consent to participate. There are numerous ethical guidelines to which clinical trials must subscribe to ensure that the human research participants are safe and can withdraw their consent at any time.
In phase 1
, small single doses are delivered to healthy humans to determine appropriate dose ranges and common side effects.
In phase 2
In phase 3
, the drug is delivered to the target population (in the case of drug treatments for schizophrenia, it would be given to people with schizophrenia) who are otherwise healthy, over a longer period of time. Phase 2 allows the researcher to learn about the effectiveness of the drug and its safety as well as gaining more information on dosage and side effects.
, individuals of the target population who may have additional health concerns are given the drug. The purpose is to improve the knowledge learned in the first two phases by administering the drug to individuals who are more representative of the general population, as well as to show the drug’s effectiveness and side effects.
Health Canada Approval
If the drug has shown successful results over the three phases of clinical trials, the researcher or developer can submit a New Drug Submission (NDS) to the TPD. The TPD will review the application and the results of all the stages of drug testing and development. If the benefits of the drug to the target population outweigh the risks or potential risks of the drug or of not approving the drug then Health Canada will issue a Notice of Compliance to allow the drug to be marketed in Canada. A Notice of Compliance with Condition can also be issued if Health Canada feels that the drug shows good potential benefit but additional studies are needed. Health Canada will also work with the manufacturer to create a product monograph which ensures that physicians have the information needed to use the drug properly. The drug will also be given a Drug Identification Number (DIN) which marks the drug’s official status as an approved drug in Canada and allows it to be marketed.
After approval, Health Canada continues to monitor its effectiveness and side effects and can remove approval if needed at any time. If a drug fails the drug approval process and the manufacturer is not granted authorization to sell the drug, then the manufacturer can re-submit their application at a later date with additional supporting data. They can also appeal this decision. Physicians are able to administer drugs that are not available in Canada under special circumstances through the Special Access Program of the Health Products and Food Branch of Health Canada.
The Drug Pricing Process
The Patented Medicine Prices Review Board (PMPRB) reports to the Federal Department of Health and ensures that the prices of patented medicines are not “excessive” by reviewing the average price of each drug approved for market in Canada. They use the median price of several comparator countries and determine that the price in Canada shall not exceed the median.
The next step involves different bodies gathering formal patient feedback. These bodies conduct Health Technology Assessments (HTA) by looking at comparative data, economic information and patient input. With all of this information they determine the value of the drug relative to best practices in pharmacy and medicine. Based on their value determination, they will or will not recommend a drug for provincial and territorial drug plans and make recommendations regarding the amount of coverage offered by public plans. These bodies are:
- The Common Drug Review (CDR) of the Canadian Agency for Drugs and Technologies in Health (CADTH) which is responsible for reviewing drugs for all of the provinces except Quebec.
- INESSS (Institut national d'excellence en santé et services sociaux) is responsible for the same in Quebec.
The review process can happen simultaneously to Health Canada’s approval process but no recommendation will be made until after Health Canada has approved a drug.
The next step in the process is to actually assign a price to the drug. The pan-Canadian Pharmaceutical Alliance (pCPA) conducts provincial and territorial negotiations with manufacturers for brand name drugs. All drug plans across Canada work with pCPA to achieve greater value for publicly funded drug programs.
Once a price is settled on between pCPA and the manufacturer (based on the recommendation from CADTH or INESS), each province gets to further negotiate the price and determine where the drug will be placed on their provincial formularies and plans. In Ontario, this is handled by the Committee to Evaluate Drugs, a branch of the Ministry of Health, who make recommendations to the Ontario Public Drug Program.
How you can get involved:
Write to the Ontario Public Drug Program about your concerns regarding access to medications here.
Write to your local member of provincial parliament (MPP) to advocate for better access to medications. You can find a list of Ontario MPPs here.
Sign up for our advocacy alerts to hear about when new Schizophrenia medications are up for review by CADTH. Email [email protected] with the subject line “Advocacy Alerts”.
Provide patient input to CADTH’s Common Drug Review through this link.
Learn about how you can take part in the Patient Evidence Submission to share your experience with The Committee to Evaluate Drugs. To share your experience visit this website.
To learn about current clinical trials and how you can get involved, visit this website.
Health Canada, Government of Canada. (2018). Drug and health product review and approval. Retrieved from: https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval.html.
Ministry of Health and Ministry of Long-Term Care, Government of Ontario. (2018). Ontario public drug programs. Retrieved from: http://www.health.gov.on.ca/en/pro/programs/drugs/how_drugs_approv/how_drugs_approv.aspx.
Consortium of Canadian Centres for Clinical Cognitive Research. (2019). How drugs are approved. Retrieved from: http://c5r.ca/how-drugs-are-approved/.
Patented Medicine Prices Review Board, Government of Canada. (2019). About the Patented Medicine Prices Review Board. Retrieved from: http://pmprb-cepmb.gc.ca/home.
Therapeutic Products Programme, Health Canada, Government of Canada (2000). How drugs are reviewed in Canada. Retrieved from: http://publications.gc.ca/collections/Collection/H30-12-11-2000E.pdf.
Canadian Agency for Drugs and Technologies in Health. (2019). CADTH Common Drug Review (CDR). Retrieved from: https://www.cadth.ca/about-cadth/what-we-do/products-services/cdr.