Nutrasource Blog
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Follow the Nutrasource blog for commercialization tips, regulatory updates, and more - written by our senior scientists and regulatory specialists for the health products industry. Nutrasource is your trusted partner for bringing products to market confidently and with strong supporting science. As a full-service contract research organization (CRO), we help health product companies discover a..
Nutrasource Blog
3w ago
UNDERSTANDING MASTER FILES
Master Files (MFs) are reference documents that contain proprietary and/or publicly-available data on aspects of drug or Natural Health Product (NHP) safety, efficacy, and/or quality that are submitted to regulatory authorities in support of various application types, including Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), Abbreviated New Drug Applications or Submissions (ANDAs / ANDS), New Drug Applications or Submissions (NDAs / NDS), and Product Licence Applications (PLAs).
MASTER FILES SUBMISSION
MFs are submitted by i ..read more
Nutrasource Blog
1y ago
Today’s consumers are doing more research about the products they purchase than ever before ..read more
Nutrasource Blog
1y ago
As a result of the pandemic, respiratory and seasonal illnesses, and other emerging threats, consumers are more interested, invested, and involved in their wellbeing than ever before. When it comes to health products, consumers are motivated by those that are clean or naturally-sourced, convenient, scientifically substantiated, and tailored to meet their personal needs. Thus, driving industry trends towards transparency, sustainability, personalization, and virtual approaches.
  ..read more
Nutrasource Blog
1y ago
If you're already selling your supplement on Amazon in the U.S. or elsewhere around the globe, Canada is a natural next step to achieve growth and gain market share.
But if you're looking to enter the Canadian market for the first time via Amazon.ca, be warned - it's not as simple as setting up an account and listing your products ..read more
Nutrasource Blog
1y ago
Companies looking to obtain authorization to market a new pharmaceutical must either file a New Drug Submission (NDS) to Health Canada or a New Drug Application (NDA) to the United States Food and Drug Administration (U.S. FDA), depending on their market-of-interest.
The regulatory dossier must include data around the following:
Pre-clinical (in vitro and in vivo) studies
Clinical (human) studies
Details on the manufacturing, packaging, and labelling of the drug substance and drug product
Therapeutic claims and side-effects
In summary, what this means is that the regulatory dossier mu ..read more
Nutrasource Blog
1y ago
In today’s regulatory climate of full accountability and transparency, it is critical to have strong science to back-up any claim made on a health product, be it a dietary supplement sold in the United States (U.S.) or a Natural Health Product (NHP) marketed in Canada. This will be a key component of your dietary supplement and NHP marketing strategy. We know advertising health products is critical to your marketplace success and we want to help you make sure it is done the right way.
Firstly, it is important to note that while dietary supplements are equivalent to the NHP categories, there ar ..read more
Nutrasource Blog
1y ago
Background
On July 6th, 2022, Health Canada published new labelling requirements under the Natural Health Products Regulations (NHPR). These changes are driven by a need to help consumers make informed choices and manage preventable harms through consistent, clear, and easy to understand product labels. The amendments also ensure alignment with rules that have already been established for comparable non-prescription drugs. Below is a summary of the key requirements ..read more
Nutrasource Blog
1y ago
Determining the appropriate regulatory pathway is not always straightforward, especially when introducing a product from Canada into the U.S., or vice versa. For example, some foods contain components that when isolated could be a dietary supplement/Natural Health Product (NHP), and under certain circumstances, even a drug ingredient.
By the end of this blog post, you should have a good understanding of who regulates supplements in the US and Canada, and how they differ from food and drug regulations. Continue reading if you are looking for information on how to sell supplements in C ..read more
Nutrasource Blog
1y ago
The first steps when developing any health and wellness product is to know first, what it is and second, how its regulated and in each target market as categorization may differ between regions. Many factors are taken under consideration when determining product classification as summarized in the figure below ..read more
Nutrasource Blog
1y ago
You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.
What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation ..read more