New drugs and medical devices approved in 2017

In 2017 Health Canada approved 67 new drugs, giving you new and innovative options for treatment, prevention and diagnosis of various health conditions. Twenty-four percent of these were approved through an expedited pathway, to address unmet medical needs. We approved new generic drugs and biosimilars - bringing more choice and more affordable options.

36 New Active Substances

Some new drug submissions introduce new active substances - medicinal ingredients that have never been approved for sale in Canada. Thirty-six percent of these were approved through an expedited pathway.

31 Other New Drug Submissions

Other new drug submissions use the same or similar substances already approved for sale in Canada. They may offer new dosages or treat different conditions, and include 3 new biosimilars.

138 New Generic Drugs

Generic drugs contain the same medicinal ingredients as brand name drugs and cost less than their brand-name equivalents.

3 New Biosimilars

Biosimilars are drugs that have been demonstrated to be highly similar to biologic drugs that were already approved for sale.

Medical devices are products that are used for diagnostic and/or therapeutic purposes. Newly approved medical devices provide a broader range of options used to treat, manage, diagnose or prevent a disease or a physical condition.

6 Medical Devices with Novel Technology

These medical devices introduce a new apparatus, appliance, software or material with novel technology never before approved for sale in Canada.

482 New Class III and IV Medical devices

There are different classes of medical devices, ranging from Class I to IV. Class I devices are considered low-risk devices - for example, a tongue depressor. Class IV devices present the greatest potential risk - for example, a pacemaker.

We approve applications to allow companies and researchers to conduct clinical trials on drugs and medical devices in Canada. We also grant access to doctors for certain drugs and medical devices that have not yet been approved for sale in Canada through our Special Access Programs.

Clinical trials

New clinical trials mean access to more innovative choices.

• 1229 new clinical trial applications for drugs were approved
• 199 new investigational testing applications for medical devices were approved

Special access programs

Access to unapproved drugs and medical devices may be granted for emergency use or to patients with serious or life-threatening conditions. Our special access programs operate 24 hours a day, 365 days a year.

• 12,887 requests for special access to drugs were authorized
• 2,401 requests for special access to medical devices were authorized

It is not possible to know or predict all of the possible side effects of a drug, or the adverse events associated with a medical device, through clinical studies. Once drugs and medical devices are available in Canada, we monitor and evaluate reports of suspected adverse events.

Post-market adverse drug reaction and medical device incident reports

We received 880,000 post-market reports of adverse reactions to drugs, and medical device incidents, from domestic and international sources.

Post-market actions

We initiated 987 post-market actions, including reviewing risk management plans and periodic safety update reports, completing safety reviews and their summaries, issuing risk communications, and reviewing advertising complaints.