Health Canada: Drug and Medical Device Highlights 2018Published on July 15, 2019
Author: Bhavesh Patel
Health Canada published the report on drugs for human use, medical devices and drugs for veterinary use. The report sets out new drugs and medical devices approved for sale in Canada during 2018.
Forty of the new drugs approved in 2018 introduced new active substances: medicinal ingredients that have never been approved for sale in Canada. Thirty-five percent of these were approved through an expedited pathway, to address unmet medical needs, including the first gene therapy approved in Canada.
New Drugs and Generics Drugs
In 2018, Health Canada approved 78 new drugs, providing new and innovative options for the treatment, prevention and diagnosis of various health conditions. Health Canada also approved 135 generic drugs and 4 new biosimilars in 2018.
Clinical Trials and Special Access Program
Health Canada approved applications to allow companies and researchers to conduct clinical trials on drugs in Canada. New clinical trials facilitate access to more innovative choices. In 2018, 1209 new clinical trial applications for drugs were approved, including several for advanced cell and gene therapies and targeted therapies for oncology.
There is also special access to drugs that are not available in Canada. This program provides a pathway for doctors to request treatments for their patients that are otherwise unavailable. In 2018, 13,125 requests for special access to drugs were authorized.
Health Canada continues to monitor and evaluate reports of suspected adverse drug reactions once a drug is approved for sale. In 2018, Health Canada received 1,091,696 post-market reports of adverse reactions to drugs for human use from domestic and international sources. Of these reports, Health Canada took 620 post-market actions related to drugs for human use, including informing the public and healthcare professionals of new safety information, recommending labelling changes, and even removing a drug from the market in the most serious situations.
Risk Management Plans
In addition to the Risk Management Plans (RMPs) associated with a drug submission, Health Canada also reviews RMPs submitted by companies after a drug is available for sale in Canada. Approximately 120 RMPs were received from various companies with opioid products on the market.
As part of its post-market oversight, Health Canada also regulates the advertising of drugs sold in Canada to ensure that companies are not making false claims about their products. In 2018, Health Canada reviewed 131 advertising complaints related to drugs for human use.
Health Canada also developed the Regulatory Review of Drugs and Devices (R2D2) initiative in 2017 to provide more timely access to drugs and medical devices to patients. To learn about Building International Partnerships through International Coalition of Medicines Regulatory Authorities (ICMRA), International Council for Harmonization (ICH) and Australia-Canada-Singapore-Switzerland (ACSS) Consortium please visit following link under reference.
In Canada, Medical Devices categorized into four classes based on potential risk. These range from Class I, which have the lowest potential risk (e.g. a tongue depressor) to Class IV, which have the highest potential risk (e.g. a pacemaker).
In 2018, Health Canada approved 355 new Class III medical devices and 80 new Class IV medical devices. These provide a broader range of options used to treat, manage, diagnose or prevent a disease or a physical condition.
Four of the new Class IV medical devices included “novel technology”: a new apparatus, appliance, software or material with novel technology never before approved for sale in Canada.
In 2018, Health Canada received 28,176 post-market reports of medical device incidents from domestic and international sources from which 54 post-market actions were pursued.
For Regulatory review, Action Plan on Medical Devices, Digital Health Technologies, Safety, Effectiveness and Quality of Medical Devices, Medical Device Life Cycle, Clinical Trials (Investigational Testing) please visit following link.
Drugs for Veterinary Use
New drugs for veterinary use provide more ways to help maintain and improve the health of animals. In 2018, Health Canada approved 8 new veterinary drugs for companion and food-producing animals. This enabled access to innovative new products and therapies to help manage the health and wellness of animals. Health Canada also approved 7 new generic veterinary drugs to provide additional options for more cost effective prevention and treatment.
Clinical Trials and Emergency Drug Release Program
Health Canada approved applications to allow companies and researchers to conduct clinical trials on veterinary drugs in Canada. In 2018, 86 new Experimental Studies Certificates that support clinical trials or research activities were authorized. Health Canada’s Emergency Drug Release Program grants access to drugs for veterinary use that have not yet been approved for sale in Canada. In 2018, 644 requests under the Emergency Drug Release program were authorized.
For more details on Drugs for Veterinary Use update please visit following link.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Bhavesh Patel is an active member of CAPRA Education Day and Website Committee and has been working with CAPRA for 10 years. Bhavesh has 10 years of experience in Regulatory Affairs in Canada. His regulatory experience encompasses prescription drugs, non-prescription drugs, natural health products, medical devices, cosmetics and foods. In his spare time, he enjoys professional writing, which includes regular contributions to the CAPRA online Blogs. Recently, Bhavesh co-authored chapters for the RAPS 2018 book, “Fundamentals of Canadian Pharmaceuti
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....