On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018. The report provides information regarding Health Canada drug (human or veterinary use) and medical device approvals, as well as published safety issues in 2018. In summary, in 2018, Health Canada approved 78 new drugs for human use (40 involving new active substances), 135 new generic drugs, and 4 biosimilars.
Moreover, the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) released their Drug Submission Performance Annual Reports for the 2018-2019 Fiscal Year, which include information and statistics relating to drug submission review activity from April 1, 2018 to March 31, 2019.
Related Publications & Articles
-
Supreme Court of Canada: methods of medical treatment unpatentable, validity of Janssen’s paliperidone dosing regimen patent upheld
Today the Supreme Court of Canada released its decision in Pharmascience Inc v Janssen Inc, 2026 SCC 26 on the patentability of methods of medical treatment, dismissing Pharmascience’s appeal.Read More -
Ministerial Reliance Order permitting Health Canada to rely on decisions of foreign regulators now in force
On July 15, 2026, the Minister of Health’s Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs ("Reliance Order”) was pub...Read More -
Health Canada seeks feedback on pilot to prioritize domestically manufactured generic drug submissions
In a News Release dated July 15, 2026, Health Canada advised that it is modernizing its regulatory processes to improve efficiency while maintaining high standards for safety, efficacy and quality.Read More
