Time to market for drugs approved in Canada between 2014-2018: an observational study

Objectives: This study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission and compares Canadian and American times. Drugs approved between January 1, 2014 and December 31, 2018 are examined. 

Design: Descriptive study

Data Sources: Websites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, World Health Organization and previously published articles.

Interventions: None

Primary and Secondary Outcomes: The primary outcomes are time to market, time from patent application to New Drug Submission (pre-NDS time), review time, time from approval to availability (postapproval time) and factors that may influence the pre-NDS time. The secondary outcome is a comparison of Canadian and Amer...