In addition to governing pharmaceutical and medical device research, Health Canada provides oversight and approval of nutraceutical clinical research and natural health products conducted in Canada. This integrated approach allows the department to hold trials and their safety and quality considerations closer to a recognized pharmaceutical research-standard than research conducted in other jurisdictions where regulatory oversight of nutraceuticals and natural products is deficient, or in some cases, absent.
While natural product research in the US typically does not require FDA approval, Health Canada provides regulatory oversight of the research of natural health products conducted in Canada for both domestic and foreign Sponsors. The department has recently also developed an expedited pathway for the review and approval of clinical research trials pertaining to both drugs and natural health products for COVID-19. Health Canada continues to review and approve Clinical Trial Applications (CTAs) for all other indications in accordance with its internally mandated service timelines. Sponsors from around the globe have enjoyed this continued review amidst COVID-19, with each CTA being reviewed with a risk-based approach in terms of trial feasibility and, more importantly, safety, during COVID-19.
The last comparable pandemic to COVID-19 was the Spanish Flu (1918), which gave rise to the formation of Health Canada itself. A hundred years later, COVID-19 has precipitated its own evolution within the already established health authority. Health Canada has responded to COVID-19 with the formation of new regulatory health authorities in Canada on both the provincial and federal levels. as well as initiating regulatory reform within Health Canada.
Global disruption of trials slated to begin in Europe and the US has led to considerable site re-selection by industry Sponsors. This has been true, to a lesser degree, from other areas of the world due to the unique regional contexts and existing industry dynamics.
Canadian sites have accommodated many of these projects due to a lesser degree of industry disruption when compared to other jurisdictions. Research facilities and businesses that operate and maintain research clinics have been declared an essential service by local government; remaining functional and operational while incorporating all precautions mandated by local & global health authorities. This has emerged as a huge and unlikely advantage to industry Sponsors willing to consider Canadian sites while facing total shut-down and/or significant disruption elsewhere. Simultaneously, many global Sponsors are now also learning the other advantages of conducting natural product research in Canada, due to the well-recognized threshold of regulatory oversight not provided by other jurisdictions.
dicentra is a full-service Contract Research Organization (CRO) and professional consulting firm that specializes in addressing all matters related to safety, quality, and compliance for all product categories in the life sciences and food industries.
Our beautiful CRO and in-house research clinic/site is located in the heart of downtown Toronto, one of the world’s most multicultural cities, boasting over 200 ethnic groups. With over 6.5 million people located right at our doorstep, we are able to recruit study subjects for clinical trials at a very fast rate, allowing our study Sponsors to obtain results and achieve their objectives sooner.
Working with global brands, we have completed over 18,000 projects and serviced over 1,200 companies internationally. Our clients rely on us to help protect their bottom line while integrating our team as a part of theirs. This is a result of the continuous efforts we make to provide the highest level of client care. dicentra evaluates, implements, and provides all the necessary support for nutraceutical and food products to gain market access and build confidence in your brand.
For clinical research, inquiries contact Mr. Charles Galea, Director of Clinical Research Business Development, dicentra – charles@dicentra.com to see how the dicentra team can assist you in meeting and exceeding your clinical research goals.