Canada leads in new medicine approvals, outpacing OECD Median

Report shows Canada launches more new medicines than most OECD countries, with high-cost and specialty drugs dominating the market

Canada leads in new medicine approvals, outpacing OECD Median

The Patented Medicine Prices Review Board (PMPRB) has published the 8th edition of its annual Meds Entry Watch report.  

The analysis reveals that Canada has a higher number of new medicine launches compared to the median for Organisation for Economic Co-operation and Development (OECD) countries.  

Most new medicines come to market with high treatment costs, and specialty medicines, such as biologic, orphan, and cancer treatments, are increasingly prevalent in the new drug landscape.   

The Meds Entry Watch report examines medicines approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.  

This edition explores trends in the market for new medicines approved since 2017, highlighting the 55 medicines that received first-time market approval in 2021 and providing a preliminary analysis of the 48 medicines approved in 2022.  

The report also includes an analysis of medicines new to Canada in 2020, detailing approval rates per quarter over the past five years.   

From 2017 to 2022, an average of 50 new medicines were approved internationally each year, with half receiving an orphan designation from the FDA or EMA. In 2021, 55 new medicines were approved by the FDA, the EMA, and Health Canada, marking a five-year high.

In 2022, 48 medicines received first-time market approval. Canada approved 43 new medicines in 2021 and 46 in 2022, surpassing the five-year average of 40.   

New medicines with Canadian sales accounted for 81 percent of all new medicine sales in the OECD in Q4-2022, indicating that Canada continues to approve and sell the higher-selling medicines approved internationally.