Canada Speeds Access to Safe, Effective Medicines

Health Canada

Canadians expect timely access to safe and effective drugs and medical devices. Health Canada is taking practical steps to modernize and improve the efficiency of its regulatory processes, while maintaining its high standards for safety, efficacy, and quality.

Over the last three months, Health Canada has approved 537 new drugs and medical devices to help Canadians manage and treat a range of health issues. This includes three generic versions of semaglutide, the first G7 country to do so.

In addition, to help bring more medications and treatments to Canada sooner, Health Canada has published a Ministerial Reliance Order. The Order allows the department to review certain parts of drug submissions faster by using decisions or documents produced by select foreign regulators. This approach maintains Canada's requirements for safety, efficacy and quality, while reducing unnecessary duplication. A more efficient process will also encourage manufacturers to bring products to Canada. The first classes of drugs that will be accepted by Health Canada under the Order include drugs for pediatric use and veterinary drugs.

At the same time, Health Canada is seeking feedback on a proposed approach to prioritize the review of certain generic drug submissions that involve Canadian manufacturing. Supporting Canada's generic pharmaceutical and life sciences sector will play a key role in enhancing the security of the drug supply and preventing harmful shortages that could negatively impact the health of Canadians.

Complementing Health Canada's regulatory modernization efforts, the Canadian Institutes of Health Research (CIHR) continues to support health research and clinical trials that generate the evidence needed to evaluate new drugs, medical devices and other health products, helping strengthen Canada's life sciences ecosystem and improve access to innovative treatments for Canadians.

These initiatives are helping build a more modern and efficient regulatory system-one that supports faster and expanded access to drugs for Canadians, without compromising Canada's high standards for safety, efficacy and quality.

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