441-02707 (Health)

The Canadian Institutes of Health Research (CIHR), Canada's federal funding agency for health research, has invested over $1 billion in cancer research between 2018-19 and 2022-23. This includes an investment of over $67 million in cancers impacting the brain and nervous system.

Some examples of recent CIHR-supported research projects include the work of :

• Dr. Daniel Shramek at Toronto’s Sinai Health System ($1.05 million over 5 years), targeting low-grade gliomas, which are found in younger patients;
• Dr. Daniela Quail at Montreal’s McGill University is researching immune-targeted therapies in glioblastoma treatment ($1.1 million over 5 years) and;
• Dr. Sheila Singh – a Tier 1 Canada Research Chair in Human Cancer Stem Cell Biology at Hamilton’s McMaster University -  recently received an award of $1.4 million over 7 years. Her lab has recently co-led a project which discovered a pathway that cancer cells use to infiltrate the brain and revealed new therapeutic approaches which may block the spread of tumour cells.

Health Canada recognizes the importance of patients having access to therapies that may help treat their conditions, such as brain cancer. Drugs are being developed that may alleviate or prevent some of the symptoms of such diseases, and, over time, these drugs may prove to be of significant clinical benefit with respect to improving survival of those suffering from these diseases.

The health and safety of Canadians is Health Canada’s top priority. Under the Food and Drugs Act and its Regulations, all products sold or marketed in Canada that make a therapeutic claim need to be approved by Health Canada. Every drug submission is reviewed by Health Canada scientists to assess the product’s safety, efficacy and quality to determine whether the risks associated with the product are acceptable in light of its potential benefits. If they are, then the drug will be approved for sale in Canada.

Health Canada’s review timelines are comparable with other international jurisdictions, including the United States’ Food and Drug Administration and Japan’s Pharmaceuticals and Medical Devices Agency. The Guidance Document: The Management of Drug Submissions and Applications provides details on the process and timeline for the drug review process. It should be noted that, in the absence of a submission from a sponsor (i.e., pharmaceutical company), Health Canada cannot authorise a therapeutic product, regardless of whether the product is authorized elsewhere. The decision to submit a drug application for review is made by the sponsor.

Health Canada has policies in place to help facilitate the authorization of promising new drugs in Canada. The Department’s Notice of Compliance with Conditions (NOC/c) policy facilitates access to new drugs to patients suffering from serious, life-threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or for which a significant increase in efficacy or a significant decrease in risk is demonstrated in relation to an existing drug marketed in Canada. A Notice of Compliance (i.e. authorization) issued under the NOC/c policy may be granted for a drug product with promising clinical benefit, provided that it possesses an acceptable safety profile based on a benefit/risk assessment and is found to be of high quality. Additionally, the Priority Review policy and guidance document enables an accelerated review target date of 180 days (instead of the standard 300 days) for drugs intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses or conditions.

Health Canada also understands the importance of modernizing our regulatory frameworks to enable the authorization of promising new therapies and reduce regulatory barriers to innovation that could improve the health of patients in Canada. The Department is advancing a regulatory modernization plan that aims to provide greater regulatory flexibility in support of innovative research and health product development. This plan will help us to regulate the risks, benefits and uncertainties of more diverse and complex products, such as potential brain cancer drugs. As part of these efforts, Health Canada continues to consult on all proposed policy and regulatory initiatives.