A rigorous review process to ensure safety and efficacy is a must when it comes to the development of novel therapies. As the Manager of Regulatory Affairs at Altasciences, understanding and adhering to global regulations and guidelines is a significant aspect of my job. Compliance with the different Regulations from Health Canada, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), to the International Council for Harmonization (ICH), is crucial to ensure the well-being and safety of patients.

Regulatory agencies around the world strive to balance the critical elements of speed and safety. Each agency has its own processes and timelines, which they update periodically, to maximize productivity in the relevant geographic regions. In this regard, the EMA recently implemented a new process that “aims to ensure the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.” But how does this compare to Health Canada’s Clinical Trial Applications (CTAs)?

In reviewing these updated EMA regulations and new guidance, it occurred to me that the existing Canadian CTA timeline for review by Health Canada (30 calendar days) may provide an advantage for drug developers, especially since Canadian trials can be used to support a request for market authorization in the EU (including the UK, and other regions). According to the new EU-CTR regulations, clinical trial review timelines may vary from 60 to 106 days for the Part I Assessment (with a comparable timeline for the Part II Assessment), in comparison to the Health Canada default 30-calendar-day review period. Health Canada also has a seven-day turnaround review for eligible comparative, single-dose BA/BE studies), and boasts a 100% “on-time” review target, which can be verified here.

If Health Canada requests clarification about the contents of a CTA, sponsors have two calendar days to respond. If two days aren’t enough, sponsors can ask for a short extension (if permitted and granted) to gather the information requested by Health Canada. From my perspective, the new EU-CTR process does not provide as much flexibility. The EMA timeline (Part I assessment) for queries and responses includes 12 days for sponsors to respond, 12 days for the member state to review, and seven days for consolidation—much longer than in Canada. There is no option with the EMA to request an extension, perhaps because the time allotted initially is so generous.

Health Canada also allows for a CTA “withdrawal without prejudice,” if sponsors need more time and are not able to meet the two-calendar-day deadline for a response, or if the information provided to Health Canada is deemed not satisfactory and a major update to the CTA is required. At any time during the formal review, a sponsor can withdraw a CTA and resubmit without financial penalty. Because there is no cost to submit a CTA with Health Canada, there is no forfeit of submission fees for sponsors who withdraw (aside from the fees paid to a CRO to perform the re-submission). The 30-day review clock starts over when the CTA is resubmitted.

Drug developers might also appreciate the less stringent translation requirements in Canada. Health Canada requires only English and French, and only for some trial documentation; in the EU, the local language for all EU member states needs to be provided, even in Phase I. Using the Health Canada process means lower administrative burden and cost early on, and the translations can be done later in the process, when the chances of making it to market are higher.

Once a Canadian CTA receives a No Objection Letter (NOL), and the study is completed with no major safety issues, the results can be used to support further clinical development in the region where final market authorization will be requested. This way, sponsors can benefit from the speed of the Canadian system in Phase I, and complete all the local regulatory requirements in their home region for later clinical phases.

Conclusion

Clinical research plays a critical role in advancing drug development of new and innovative treatments. All ICH countries, including Canada, provide a rich and well-regulated environment to investigate drugs in humans. Choosing Canada to conduct early phase clinical trials is an advantageous option for sponsors aiming to move quickly and efficiently with their clinical trial program. The CTA process in Canada may facilitate the clinical drug development program for sponsors and allow investigational drugs to get to market faster to treat, prevent, or cure numerous diseases, and to improve quality of life for people around the world.

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Roland has nearly seven years of experience in Regulatory Affairs and Compliance in Canadian Regulations, with a good knowledge of Global Regulations (FDA, EMA, TGA, etc.) and a deep expertise in Health Canada’s drugs and cannabis regulations. As Manager of Regulatory Affairs at Altasciences, Roland oversees CTAs to Health Canada for small drug molecules, biologics, cannabis, and natural health products. He provides sponsors with guidance on regulatory strategies and gap analysis, as well as consultancy and liaison support between the sponsor and Health Canada.