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
-
Health Canada launches new Clinical Trial Search Portal and publishes updated guidance
As part of its efforts to modernize clinical trials and enhance transparency (see our previous article), Health Canada has launched a new Clinical Trial Search Portal, replacing the Clinical Trials Da...Read More -
New regulatory amendments formalize updates to the drug and medical device shortages framework
On June 17, 2026, Health Canada published the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices).Read More -
Medical device updates: MDEL modernization, Class III & IV licence applications, and MDD performance reports
As we previously reported, Health Canada announced that the Phase II amendments to the Medical Devices Regulations (MDR) regarding medical device establishment licences (MDELs) will come into force De...Read More
