In this webinar, we provide an overview of the drug approval process in Canada. Among the entities discusses are Health Canada, Canadian Agency for Drugs and Technologies in Health (CADTH), Patented Medicine Prices Review Board (PMPRB), Institut National d’Excellence en Santé et Services Sociaux (INESSS), pan-Canadian Pharmaceutical Alliance (pCPA), and the 13+ provincial and territorial health ministries.
The approval of a drug to be marketed in Canada begins with Health Canada. During this process scientists in the Health Products and Food Branch (HPFB) of Health Canada assess the safety, efficacy and quality of a the drug.
HPFB performs a thorough review of the submitted information and that usually includes pivotal clinical trials, manufacturing information, and studies that establish the drug’s mechanism of action.
If the drug is approved by Health Canada, that is just the first step to getting the drug to patients. Patients with private insurance usually get access to the new drug soon after it is approved by Health Canada. Unfortunately, patients with public health insurance have to wait much longer. That waiting period is discussed in detail in this webinar.
The webinar also examines the proposed National Pharmacare program currently being reviewed by the federal government.
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