Drug review process

The drug review process involves four key steps: Health Canada approval, Common Drug Review, price negotiations through the pan-Canadian Pharmaceutical Alliance and Formulary listing. 

1. Health Canada approval
Before a manufacturer can sell a drug in Canada, they must receive Health Canada approval. Health Canada assesses the drug’s safety, efficacy (usually compared to taking no drug at all) and quality of the manufacturing process. When a drug has met all the regulatory requirements, Health Canada issues a Notice of Compliance (NOC) and/or a Drug Identification Number (DIN). 

Health Canada has its own review process for assessing new drugs. 

2. Common Drug Review (CDR)
To have their drugs covered by the federal, provincial and territorial public drug plans, manufacturers must send a submission to the Canada’s Drug Agency. There are two types of review processes:

• The Common Drug Review (CDR) reviews new drugs, new combination products, drugs with new indications and therapeutic reviews. The CDR process involves a review of how well the drug works when compared to similar drugs used to treat the same condition and whether the drug provides value at cost. The Canadian Drug Expert Committee evaluates the clinical evidence and cost-effectiveness and provides a recommendation to the federal, provincial and territorial public drug plans on whether a drug should be listed as a benefit.
• The pan-Canadian Oncology Drug Review (pCODR) reviews cancer drugs. The pCODR Expert Review Committee (pERC) evaluates the clinical evidence and cost-effectiveness and provides a listing recommendation to public drug plans on whether a drug should be listed as a benefit.

Drugs that do not fall under the mandate of CDR or pCODR are reviewed by the Atlantic Common Drug Review (ACDR). Formulary listing recommendations are made by the Atlantic Expert Advisory Committee to the Atlantic provincial drug plans.  

3. pan-Canadian Pharmaceutical Alliance (pCPA) 
Price negotiations are conducted through the pan-Canadian Pharmaceutical Alliance to achieve greater value for publicly funded drug plans. All brand name drugs reviewed through the Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) are considered for negotiation.

4. Formulary listing decisions  
Each jurisdiction makes their final formulary listing decisions based on the expert advisory committee’s recommendation and other factors such as drug plan mandates, jurisdictional priorities, budget impact and resources. Drug formulary listing decisions for the New Brunswick Drug Plans are announced in a bulletin, which is posted on the Department of Health’s website.