The submission of new drugs to Health Canada is substantially delayed compared with submissions in the United States and the European Union.
"New drugs reached the market much later in Canada than in the US and the EU because of long delays before their submission to Health Canada," write Ali Shajarizadeh and Aidan Hollis, Department of Economics, University of Calgary, Calgary, Alberta. "For drugs that were ultimately approved in Canada and in at least one of the other jurisdictions, the mean delay from first submission in either foreign jurisdiction to submission in Canada was 540 days."
The authors determined that the capacity of pharmaceutical companies to navigate the regulatory process in less-profitable countries such as Canada — smaller companies may lack resources and expertise — and the desire to obtain approval of first-in-class drugs with higher potential sales are the main reasons for timing of submissions.
"We found that corporate capacity and priority status of new drugs are important determinants of submission delays," write the authors.
"We believe that the harmonization of the regulatory processes of the FDA and Health Canada may accelerate drug submissions in Canada," conclude the authors, although they note that the situation can vary for each drug.