Scientific Research &
NuYuga supports meaningful and scientifically rigorous research which results in providing safe, efficacious, and high quality products. Our team of researchers can provide detailed information or fact-finding for any of your product ideas. We also provide access to peer-reviewed, gold standard scientific research behind the efficacy and advantages of your health product.
In order to obtain authorization to sell a natural health product (NHP) in Canada, a product licence application must be submitted to Health Canada. As part of this product licence application, fact-finding and scientific data supporting the safety and efficacy of the NHP according to its recommended conditions of use must be included.
The purpose of the assessment is to determine whether the evidence supports the safety and efficacy of the product, including whether there is reasonable assurance that benefits of the product outweigh any risk inherent in the product’s ingredients or associated use of the product. The assessment of safety (risk) for a product depends on a variety of factors, including the conditions of use and the physical form and pharmacology of each ingredient in the product as well as the product as a whole. The benefit-to-risk profile of a product is always considered prior to a product licensing decision being made (i.e., licence issuance or refusal).
Some evidence is not considered adequate on its own to support safety and efficacy of the product and/or the medicinal ingredient.
Examples of evidence not considered adequate as sole support include:
- Compilations of evidence that have not been critically reviewed (e.g., Natural Medicines Comprehensive Database, Physicians’ Desk Reference (PDR), health and general information websites);
- Evidence without relevance to, or that cannot support safety of the medicinal ingredient(s)/product and/or efficacy of the product for use in humans (e.g., biochemical characterization study, pharmacokinetic study).
Often our clients utilize animal or in vitro evidence as the sole source of safety or efficacy evidence for the product and/or medicinal ingredient. The NHPD prefers human use; animal or in vitro experimental evidence may be considered as additional, supporting information but is not recommended to form the basis for product authorization. While animal and in vitro studies can provide plausible explanations of how a medicinal ingredient may work, they are not sufficient evidence on their own to support efficacy in humans; thus, this is where expertise in research and access to the right databases is key. What may cost our client thousands of dollars in purchasing the right papers, may cost our team a fraction thereof through membership in key databases of information, saving everyone time and resources.
Another common scenario wherein clients often request assistance is this:
The daily dose indicated on the PLA (Product Licence Application) or the product and/or medicinal ingredient is not captured within the safety and efficacy evidence provided.
So for example: The recommended daily dose of Medicinal Ingredient “Y” in the PLA is 70 mg; however, the evidence provided supports a daily dose of 150 mg. The evidence may support safety but would not support efficacy.
Here again, the client may reach a stumbling block – if they do not have access to the proper research to help facilitate their claim. This is where NuYuga expertise is instrumental.
Another integral aspect is being able to provide the NHPD with an expert opinion report. Our diverse spectrum of health experts are at your disposal to help with this.
An expert opinion may be used to supplement information that is not available in the literature (e.g., duration of use for an ingredient), or as supplementary information to support a new use for a previously approved ingredient. When using expert opinions, factors such as experience, education, the number of experts, and conflicts of interest are considered. These factors, along with any other relevant information provided, will contribute to the weighting of the expert opinion.
An expert best have:
- Training in the field or healing paradigm related to the proposed NHP or medicinal ingredient(s);
- Scientific qualifications, including experience in research methods and/or training in evidence-based health care; and
- No conflicts of interest or must disclose all conflicts of interest
This can all be provided with our NuYuga team.
Also, clients already holding NPNs for their existing products often come to us seeking to modify the strength of their claim. Our researchers can be hired for product licence amendments; thus, the claim for a lower therapeutic impact product can evolve over time as additional studies, supplemental literature, clinical use, and other sources of evidence provide more conclusiveness as to the benefits of the product. As the link between the condition, the NHP and the therapeutic outcome becomes more definitive, the applicant can provide that evidence to modify the product licence to allow for more specific and stronger health claims.
For those concerned with our team handling proprietary details, there is a way to do this confidentially by submitting what is called a “Master File”, which allows certain information to go direct to Health Canada without anyone in our agency seeing it.
Finally, our fact-finding and research skills are not only confined to the regulatory and compliance sector. Sometimes you require due diligence in other parts of your business plan. Perhaps it’s a competitive or market analysis, further research on the next evolution of your product, or any number of scenarios – whatever your needs are, our researchers will find what you want at the fraction of the time and cost – with immaculate detail, accuracy and relevancy for the success of your project.