441-02583 (Health)

Health Canada understands the importance for Canadians to have timely access to drugs that are safe, effective, and of good quality, especially for severely debilitating diseases wherein there exists an unmet medical need. As such, Health Canada continues to adapt and improve its regulatory system by decreasing review times through expedited review policies, leveraging our relationships with international regulatory agencies for collaborative review, and building frameworks for the use of real-world evidence to support regulatory decisions, all while maintaining excellence in our review standards.

To this end, Health Canada has two important regulatory pathways available for the expedited review of drugs intended to treat serious, life threatening, or severely debilitating diseases: the Priority Review policy and the Notice of Compliance with Conditions (NOC/c) policy. These expedited review pathways facilitate earlier access to new drugs with either substantial (Priority Review) or promising (Advance Consideration for NOC/c) evidence of clinical efficacy or those with an improved benefit-risk profile over available therapies that also meet the criteria under the respective policies. For additional information on these pathways, please see the Guidance for Industry - Priority Review of Drug Submissions and the Guidance Document: Notice of Compliance with Conditions (NOC/c).  

Further, Canada takes part in Project Orbis, an initiative of the United States (US) Food and Drug Administration (FDA) - Oncology Center of Excellence, that aims to give patients faster access to promising cancer treatments across the globe. It was recognized that collaboration among international regulators may allow patients with cancer to receive earlier access to products in countries where there may be delays in regulatory submissions, regardless of whether the product has received FDA approval. Project Orbis partners collaborate on the review of submissions for cancer drugs, enabling harmonized and well informed decisions at a potentially more rapid pace. The FDA, together with the Australian Therapeutic Goods Administration and Health Canada took part in the first Project Orbis collaborative review in May 2019. Since then, regulatory agencies from other countries have joined and become Project Orbis Partners, including Brazil, Israel, Singapore, Switzerland, and the United Kingdom. Since its inception in 2019, Health Canada has approved 27 cancer drugs for Canadians under this pathway.

As part of our ongoing efforts for international collaboration, Health Canada is also a member of the Access Consortium, a collaborative initiative with health regulatory agencies from Australia, Singapore, Switzerland, and the United Kingdom. The Consortium is committed to maximizing collaboration by aligning regulatory and policy approaches to facilitate work-sharing on medicines, and to reducing duplication while facilitating access to high-quality, safe, and effective drugs. In addition, Health Canada is an active participant in monthly oncology-specific teleconferences with health regulatory agencies from the US, Europe, Australia, and Japan held under a confidentiality agreement to allow for exchange of information and collaboration on specific topics related to applications under review. The objective of these teleconferences is to share clinical review information at both the pre-submission and pre-market authorisation stage, with a strong focus on clinical and statistical issues of oncology drugs under review by the agencies. 

Enrollment of patients in clinical trials can be an important option for diseases with no or limited available treatments, and are a primary source of safety and efficacy data for new drugs. Under certain circumstances, drugs that have not received marketing authorization in Canada may be accessed through a clinical trial. Information about the Clinical Trials Database and a list of clinical trials is available at Health Canada’s clinical trials database and Clinical trial search - Clinic trial search (canada.ca).

In addition to data from clinical trials, Health Canada accepts patient data (real-world evidence) and in vitro data in considering evidence of efficacy and safety of drugs on a case-by-case basis. In cases where the rarity of a condition or specific underlying mutations precludes conducting clinical trials with a meaningful number of patients, in vitro evidence may be used as a viable alternative for demonstrating drug efficacy. The acceptability of any evidence is based on factors such as scientific rigor used in producing the data, adherence to the principles of Good Laboratory Practice, and demonstration of clinical relevance.

Patients can also potentially access drugs that have not received marketing authorization in Canada through the Special Access Programme (SAP). Health Canada's SAP provides access to non-marketed drugs to health care practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The health care practitioner, typically a treating physician, initiates a request on behalf of a patient with access being contingent upon willingness of the manufacturer to provide the drug. For additional information, please visit Health Canada's special access programs: Request a drug and the Special Access Program for drugs: Guidance document for industry and practitioners

Health Canada is currently reviewing a new drug submission filed by Servier Canada Inc. seeking the market authorization of vorasidenib in Canada. The review of this submission was initiated on March 6^th, 2024. This submission was determined to meet the criteria to be granted Priority Review status with a shortened review target of 180 calendar days, compared to the performance standard of 300 days for regular submissions. Moreover, the Servier Canada Inc. application was also filed as a Project Orbis submission. Health Canada is diligently reviewing the efficacy, safety, and quality data for vorasidenib to ensure the health and safety of Canadians. The timeline to complete the review and for issuing a regulatory decision will be determined by the assessment of the data submitted. For more information on Health Canada’s management of drug submissions, please see the Guidance Document: The Management of Drug Submissions and Applications. For a list of submissions under review, please visit the Submissions Under Review web page.

Please note that vorasidenib is not currently approved in any regulatory jurisdiction worldwide. Similar to its review status at Health Canada, the US FDA and the European Medicines Agency (EMA) are currently reviewing vorasidenib for the treatment of Isocitrate dehydrogenase (IDH)-mutant diffuse glioma under their priority review and accelerated assessment pathways, respectively.

Health Canada understands the pressing need for Canadian patients to have timely access to safe and effective oncology drugs and continues to be committed to improving regulatory practices to better serve the health needs of Canadians.