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The global race to bring new drugs and medical devices to market has fuelled the rise of parallel submissions – a strategy where companies file applications with Regulatory agencies in multiple countries concurrently. A recent study by Tufts Center for the Study of Drug Development found that parallel submissions for new drugs can reduce approval timelines by an average of 9 months. While this approach offers faster approvals and wider reach, navigating the unique landscape of each region is crucial. So, how does Canada, a major player in the pharmaceutical and medical device industries, approach parallel Regulatory submissions, and how does it differ from the rest?
The Canadian Advantage: Streamlined Alignment
Unlike some countries with entirely separate regulatory pathways, Canada offers a unique advantage – the aligned review process. This allows manufacturers with their consent share information between Health Canada (the national regulatory body) and specific Canadian HTA (Health Technology Assessment) organizations like CADTH (Canadian Agency for Drugs and Technologies in Health). This sharing may take place before a Health Canada Notice of Compliance (NOC) is issued possibly leading to swifter coverage decisions by HTAs.
According to the Canadian Institutes of Health Research (CIHR) 2018 study, using an integrated process for reviewing new drugs made the HTA give recommendations 22% faster compared to the traditional sequential approach thereby leading to quicker public funding decisions and ultimately faster patient access to novel treatments.
Why other than this way: Particulars about the Canadian system
However, there are some significant distinctions to note if one wants to run parallel regulatory submissions within Canada while using the aligned review process:
- Limited Purview: To date, the aligned review process has only been available for a specific type of drug – New Active Substances (NAS) and requires manufacturer agreement.
- Evidence-Based: Canadian HTAs emphasize clinical and economic evidence more heavily than some other jurisdictions. Companies have to make sure that their dossiers are strong enough and meet specific Canadian HTA conditions.
- Provincial Angle: Public health care funding in Canada is under provincial jurisdiction. Obtaining coverage recommendations from individual provinces may require additional data or provincial-specific HTA submissions.
For Instance, The Success Story of Tecfidera
One instance proves how parallel submissions can work in Canada. They used the aligned review process for their multiple sclerosis drug Tecfidera. NOC was granted by Health Canada in June 2014 and a positive recommendation from CADTH came out just a month later in July 2014. This swift process facilitated faster provincial coverage decisions and ultimately, earlier patient access to the drug.
Parallel Submissions in Canada: A Calculated Move
However, Canada’s aligned review process doesn’t fit all drugs or devices. Companies must consider whether parallel Regulatory submissions are the best option based on each specific drug or device, target population, and available evidence. Besides relying upon regulatory experts who have a deep understanding of Canadian intricacies here is paramount as an approach to leverage it maximally through making successful market entry possible.
To ensure seamless navigation of the dynamic regulatory landscape, companies can forge partnerships with trusted experts like Freyr. Embrace the future of regulatory submissions in Canada with our unparalleled eCTD software, Freyr SUBMIT PRO, which is 21 CFR Part 11 standards compliant and has a flexible deployment model. Contact us today to learn more and embark on a journey towards enhanced efficiency and success. Request a demo today.
