Blog.nutrasource.ca

Navigating Medical Foods in the U.S. and EU

Once the check list above is cleared, you are on your way to establishing your case for a medical food. Your next step is to convert this into a narrative with a style and language … See more

Actived: 6 days ago

URL: https://blog.nutrasource.ca/blog/navigating-medical-foods-in-the-u.s.-and-eu

Master Files: What Are They and When to Use Them

WebMaster Files (MFs) are reference documents that contain proprietary and/or publicly-available data on aspects of drug or Natural Health Product (NHP) safety, efficacy, …

Category: Health Go Health

New Labelling Requirements for Natural Health Products

WebOn 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 …

Category: Health Go Health

Food vs. Dietary Supplement / NHP vs. Drug in Canada and US

WebThe Food and Drug Administration, or FDA, is the regulating body who oversees the enforcement of dietary supplement regulations in the US. Whereas, in Canada, Health …

Category: Food Go Health

The “Do’s and Don’ts” of Claims Substantiation

WebA structure/function claim (only for the U.S.): describes the role of a nutrient or dietary ingredient on the normal structure or function of the human body. In the U.S., dietary …

Category: Health Go Health

Setting Higher Quality Standards for Label Claims

WebWhen Congress passed the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a unique marketing position. Unlike prescription drugs, …

Category: Supplements Go Health

Planning for Risk Mitigation Is Key to a Successful

WebJosh Baisley, B.Sc., is Director of Domestic Clinical Trials at Nutrasource.With nearly 15 years of experience in quality assurance, clinical, pre-clinical, and regulatory affairs for …

Category: Health Go Health

VHPs in Canada: A Growing Market with a Regulated Pathway

WebThe global animal health market is projected to grow in the coming years, with an estimated compound annual growth rate of 3.36% from 2023-2028. In 2022, the Canadian Animal …

Category: Health Go Health

Food Regulation in Canada

WebThere are two pathways for non-conventional foods to achieve compliance, as described below. The Supplemented Foods Regulations (SFR), introduced by Health Canada on …

Category: Food Go Health

The 3 Requirements for Selling a Natural Health Product in Canada

WebHere is a list of just some of the additional labelling requirements for NHPs in Canada: NPN visible on the principal display panel. Caution and risk statements on the back panel. …

Category: Health Go Health

What to Look for in a Dietary Supplement CRO

WebThere are four key criteria to consider when choosing a CRO: Regulatory knowledge and expertise. Flexibility and responsiveness. Successful industry experience. Effective data …

Category: Health Go Health

Common Stability Testing Questions for Natural Health

WebCommon Stability Testing Questions for Natural Health Products (Canada) and Dietary Supplements (U.S.) Posted by Kevin Yan, M.Sc., VP Certifications & Analytics on Wed, …

Category: Supplements Go Health

Benefits of Conducting Clinical Research in Canada

WebConducting natural health product clinical trials in Canada allows the Sponsor to investigate populations and endpoints which, in the U.S., could trigger the need to file an …

Category: Health Go Health

Brief Overview of 2018 Prop 65 Updates

WebCalifornia has changed their Proposition 65 (Prop 65) requirements for consumer products, which applies to foods and dietary supplements. The intent is to make warnings about …

Category: Supplements, Food Go Health

Nutrasource Blog

WebCompanies looking to obtain authorization to market a new pharmaceutical must either file a New Drug Submission (NDS) to Health Canada or a New Drug …

Category: Health Go Health

Understanding the Differences Between Phase I, II, III

WebJosh Baisley, B.Sc., is Director of Domestic Clinical Trials at Nutrasource.With nearly 15 years of experience in quality assurance, clinical, pre-clinical, and regulatory affairs for …

Category: Health Go Health

Top 3 Reasons to Conduct Clinical Research in Canada

WebRequires ethics review. Requires ethics review. Can study non-disease and disease states. Can study non-disease states only. Benefits of Conducting Clinical Research in Canada …

Category: Health Go Health

GRAS or NDIN: Which is the Right Regulatory Strategy for

WebThere are two different regulatory routes that make sense in this case: NDIN (New Dietary Ingredient Notification) or GRAS (Generally Recognized as Safe). Both NDIN and GRAS …

Category: Health Go Health

How to Not Get Kicked Off Amazon.ca for Non-Compliant

WebA: To obtain an NPN, companies need to complete a Product Licence Application and submit it to Health Canada’s Natural and Non-Prescription Health Products Directorate …

Category: Health Go Health

Nutrasource Blog Claims

WebA structure/function claim (only for the U.S.): describes the role of a nutrient or dietary ingredient on the normal structure or function of the human body. In the U.S., …

Category: Health Go Health