Approval Process

sq_checkHow Hepatitis C Treatment Drugs are Approved in Canada and British Columbia

All new drugs, including for hep C, pass through a number of review processes before being approved for use in Canada and the provinces. The Hep C Treatment Information Project’s Drug Pipeline Diagram illustrates the review process, along with a visual of where new drugs are at in the approval process. Clicking Drug Pipeline Diagram or on the image in the sidebar to the left (or at the bottom of the page on mobile devices) will open the Drug Pipeline Diagram in a new window. You can  review the graphic as you read this page.

General Information about the Drug Approval Process

A new drug is evaluated based on the drug’s safety, how well the drug works, and what the overall value of the drug is to Canadians. The Federal and British Columbia governments do rigorous  evaluation and economic benefit analysis and seek doctor and patient input as part of their review of each new drug. These processes are completed to ensure the best possible treatments are  available and affordable to Canadians.

You will find general information about the federal drug approval process in Canada on this page. We have also outlined how drugs become approved on the provincial drug plan in British Columbia. BC’s publicly funded drug plan is called BC PharmaCare. (Each province has a slightly different drug review process because each province is responsible for their own publicly funded drug plans.)

Patient, Patient Group, and Caregiver Input

Both the Federal (Health Canada’s CADTH) and BC Provincial governments (Your Voice) have ways for patients, patient groups, and caregivers to provide input into the drug review process.

You can sign up for notices through Federal and BC government websites:

Federal
One can subscribe to receive CADTH patient group input alerts.  This is part of Step 4 on the drug pipeline graphic.

You can also sign up for our news blog that reports on changes with the drug pipeline.

Provincial
BC’s Your Voice includes a sign-up option for notification of public input when a drug is under review.  Patient, caregivers, and patient groups can give input.

If you prefer to provide input to CADTH through PHCN, you can sign up for PHCN’s Hep C TIP News and follow the directions on emails we send out about patient input opportunities.

Steps in the Drug Approval Process

Step OneStep 1: Testing

  • Scientists develop chemical compounds/drugs.
  • Initial testing takes place in labs/animals.
  • The drug company applies for permission (to the Therapeutic Products Directorate (TPD) – an office of Health Canada) to start clinical trials with people.
  • If the application is approved by TPD, the drug moves to Step 2.

Step TwoStep 2: Clinical Trials/New Drug Submission [to Therapeutic Products Directorate – TPD]

  • Clinical trials with people are started.
  • Clinical trials take years to properly research and analyze how a drug, or combination of drugs, works in people.
  • If a clinical trial shows the drug works well and that the benefits of the drug outweigh risks and serious side effects, the drug company can file a ‘New Drug’ Submission with TPD.
  • The New Drug Submission is then reviewed by TPD, for drug safety, how well the drug works (efficacy of the drug) and potential benefits and risks.

Step ThreeStep 3: Notice of Compliance + Drug Identification Number (NOC + DIN)

  • This step in the approval process looks at drug safety and efficacy (how well it works).
  • At this stage, the TPD looks at all of the information about the new drug submitted by the drug company/sponsor of the clinical trial.
  • If the New Drug Submission is considered beneficial, the drug is issued a ‘Notice of Compliance’ (NOC) and a ‘Drug Identification Number’ (DIN).
  • The ‘NOC’ and ‘DIN’ allow the drug to be sold in Canada, with official approval.
  • If a drug has a ‘NOC’ a doctor may prescribe the drug – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare. Private insurers each decide company coverage of the new drug (ie. what percentage of the drug costs they will cover).
  • If the New Drug Submission doesn’t have enough evidence, or the risks outweigh the benefits, the government doesn’t approve the drug. The company/sponsor can then provide more information/data, or appeal the decision.
  • Average time for TPD to review a drug = 18 months

Step FourStep 4: Common Drug Review by CADTH

  • After a drug is issued a NOC, the drug sponsor/company submits an application to the Federal agency, Canadian Agency for Drugs and Technology in Health (CADTH). At this stage of the process, the government analyzes a drug for economic and health value, evaluating a drug in comparison to other available drugs.
  • CADTH conducts the Common Drug Review (CDR). The CDR does economic and pricing analyses to make recommendations to the provinces on how a drug should be listed on the provincial formulary*. Private insurance companies also use the CDR recommendations to decide on how to cover the new drug.
  • An important note as it has been seen repeatedly while new DAAs have gone through the pipeline: A drug can be submitted for the CDR before the federal government issues a ‘NOC’ – but the federal government must be informed of this prior to the CDR.
  • The CDR is conducted by experts who review clinical data, economic analyses, and patient input. This committee is called the Canadian Drug Expert Committee (CDEC).
  • CDEC consider two main questions:
    • how does the drug compare to similar drugs used for the condition
    • does the drug provide value for the cost
  • The Common Drug Review can take up to 7 months from time of submission.
  • Starting in 2013, all brand name drugs coming forward for funding through the Common Drug Review (CDR) are now considered for negotiation through the pan-Canadian Pharmaceutical Alliance (pCPA). This adds between 2 weeks to 6 months to the approval process.

* The provincial formulary is the list of all drugs and treatments covered by PharmaCare. If a drug is not listed on the formulary, it is not paid for by the government.

Step FiveStep 5: Provincial Review

  • Once the CDR is completed, the BC Ministry of Health Services initiates its own drug review, to define if and how a treatment/drug will be listed on the provincial formulary for PharmaCare.
  • The “Drug Review Resource Committee”, which has teams of experts evaluate different aspects of a drug under review, does the provincial review. Both practitioners and patients are also asked for input via Your Voice.
  • Once the review is done, the Ministry of Health Services determines if and how a drug will be listed on PharmaCare’s formulary.
  • This stage of the process can take up to one year to complete.

ApprovalStep 6: PharmaCare Availability

  • After the provincial drug review is complete, a drug is available to BC residents, as per PharmaCare eligibility requirements.
  • PharmaCare defines how much the province will pay for a treatment, and when a person is eligible to receive these public benefits. See PharmaCare Covered Treatments for more information.

Further Links and Resources

Health Canada’s ‘How Drugs are Approved’

British Columbia – Ministry of Health Services Drug Review Process

Canadian Agency for Drugs and Technology in Health (CADTH)
Canadian Agency for Drugs and Technology in Health is the federal agency that oversees the Common Drug Review.

CTAC
CTAC (formally the Canadian Treatment Action Council) is a non-profit organization, which advocates for improved treatment access for people living with HIV and HCV in Canada. To explain Canada’s treatment approval process, CTAC has a quick video on youtube entitled Approval and Public Listing of Drugs in Canada – The Common Drug Review. CTAC also has other informative webinars about hep C treatments on their Videos page.

Contact us at hepctip@pacifichepc.org

The information on this website is meant as a resource only and is not intended to replace qualified medical attention. Please seek advise and guidance from your health practitioners when considering your hep C treatment options.