PNSG - Pharmacology and Drug Information

A drug monograph, referred to by Health Canada as a product monograph, is a factual, scientific document on a drug product that, devoid of promotional material, describes the drug's properties, claims, indications, and conditions of use and contains any other information that may be required for optimal, safe, and effective use.

How are drugs reviewed in Canada?

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process. This process involves reviewing a drug application by scientists in the Health Products and Food Branch (HPFB) of Health Canada and, occasionally, outside experts to assess a drug's safety, efficacy, and quality. Throughout the review process, Canadians' safety and well-being are paramount.

There has been recent criticism of how the review process is taking longer in Canada than in other countries which is contributing to anxiety on the part of patients and their physicians..