Health Canada has released their report “Drug and Medical Device Highlights 2018: Helping you maintain and improve your health”. This is part of their commitment to make more information available to patients and the public. The report covers new & innovative drugs and medical devices approved for sale in Canada and potential safety issues. You can find some of the highlights below.
Drugs for human use
Prescription pharmaceuticals, vaccines, and over-the-counter drugs are evaluated and monitored to ensure that their benefits outweigh their potential risks,
throughout their entire life cycle. In 2018, Health Canada hired additional scientific staff to increase their ability to:
- Review new drugs.
- Review cost-effective generics and biosimilars.
- Monitor the safety of drugs after they have reached the Canadian market.
- Implement new plain language requirements for non-prescription drugs.
They were also able to enhance their scientific knowledge through partnerships with trusted regulators in other countries. This helps them to make decisions that will improve the safety of drugs on the Canadian market. Other accomplishments include building international partnerships, aligning with partners in the Canadian healthcare system, communicating the risks of opioid use, regulating non-prescription drugs, and addressing antimicrobial resistance.
New drugs approved
78 new drugs were approved in 2018, expanding the available options for innovative treatment, prevention, and diagnosis of various health conditions. 40 of these drugs included new active substances – medicinal ingredients that had never been approved for sale in Canada. Many of these will address unmet medical needs, including the first approved gene therapy and a new treatment for cystic fibrosis patients.
135 generic drugs and 4 biosimilars were also approved, which brings more affordable options to Canadians.
Clinical trials & Special Access Programme
In 2018, 1209 new drug clinical trial applications were approved, including some for advanced gene therapy and targeted therapies for oncology.
The Special Access Programme provides a pathway for doctors to request treatments for patients that would not otherwise be available in Canada. Access to unapproved drugs can be granted for emergency use of for the treatment of serious or life-threatening conditions.
Health Canada continues to monitor and evaluate adverse reactions of drugs once they have been made available. In 2018, they undertook 620 post-market actions related to drugs for human use – these actions can range from informing the public to removing the drug from market.
Medical devices are essential to Canadians in order to improve health and well-being. In the regulation of these devices, there is a risk-based approach; the approval will depend on the risks that may be associated with the device. These risks are categorized from Class I (a tongue depressor) to Class IV (a pacemaker), with the potential risk increasing along with the class.
Health Canada has described a three-part strategy to improve the safety and effectiveness of medical devices and optimize health outcomes for patients:
- Improving how devices get on the market in Canada.
- Strengthening monitoring and follow-up of devices once they are being used by Canadians.
- Providing more information to Canadians about the medical devices they use.
In 2018, they created a new division to review medical devices involving digital health technologies. This division will focus on addressing safety issues related to digital health technologies such as
securing private health information and preventing hacking and cyber security threats.
New medical devices approved
There were 355 new Class III medical devices approved in 2018, as well as 80 new Class IV devices. These provide a broader range of options used to treat, manage, diagnose or prevent a disease or a physical condition. 4 of the Class IV devices used new technology that had never before been approved for sale in Canada.
Clinical trials & Special Access Programme
Investigational testing allows companies and researchers to test medical devices through clinical trials. In 2018, 199 investigational testing applications were approved. As mentioned above, the Special Access Programme allows doctors to request devices that are not approved for sale in Canada, and would otherwise not be an available option.
At the time of market approval, it is not possible to predict all the possible adverse effects that could be associated with a medical device. In 2018, Health Canada undertook 54 post-market actions related to medical devices, including informing the public of new safety information, recommending labelling changes, and removing a device from the market.
The full report, including a detailed list of all the new drugs and medical devices approved in 2018, can be found here.
If you have any feedback or suggestions regarding the report, send an email to hc.hpfb.engagement-