Nutrasource Blog

The Importance of Investigational New Drug (IND) Applications and Clinical Trial Applications (CTAs) for Drug Development Strategy

Posted by Nutrasource on Thu, Jun 20, 2024


Drug development is a complex, multi-phase process, involving rigorous testing to ensure safety and efficacy. Prior to drug or biologic testing in human subjects, approval must be obtained from regulatory authorities like the United States (US) Food and Drug Administration (FDA) if the drug or biologic is to be marketed in the US and Health Canada if Canada is the market of interest. In the US, approval is obtained through an Investigational New Drug (IND) application, while in Canada, the application required is a Clinical Trial Application (CTA).

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Tags: Regulatory

Marketing Claims for Natural Health Products in Canada

Posted by Tania John, M.Sc. on Fri, May 03, 2024

Natural Health Products (NHPs) are naturally occurring substances that maintain, promote, or restore good health.1 To receive Health Canada approval, an NHP must carry at least one health claim and that health claim must have a health context. For example, “Source of antioxidants for the maintenance of good health.” In addition to the recommended use or purpose statement(s), there are several parameters that form part of an NHP’s Product Licence or Terms of Market Authorization (TMA), including product classification, product representation, composition / ingredients, directions for use, duration of use, risk information, allergen source disclosure, storage conditions, etc.2 Marketing claims can be made around any of these aspects, and while they do not typically appear in the Product Licence Application (PLA) since they lack the required health context, they need to be consistent with the product’s TMA. Product performance, content, comparisons, representations of opinion and authorization, and side effect claims may also be considered marketing language.3 Some examples of acceptable advertising claims are provided in the Table below.

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Tags: Product Marketing, Regulatory, Dietary Supplements/Natural Health Products

Master Files: What Are They and When to Use Them

Posted by Nutrasource on Tue, Mar 05, 2024




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).


MFs are submitted by individuals or companies that develop, manufacture, or supply drugs or NHPs, and are known as the MF Holders. In some jurisdictions the entire MF is strictly confidential between the MF Holder and the regulatory Agency, whereas in others restricted access is granted to Applicants authorized by the MF Holder. Once authorized, the Applicant is allowed to reference the MF in their own submission(s).

The purpose of a MF is to provide sufficient details to the regulatory Agency to satisfy safety, efficacy, and/or quality requirements. The information used in a MF can include specifics about the facilities, processes, and components used in manufacturing, processing, packaging, and storage, without disclosing proprietary information to the Applicant. The MF Holder is responsible for maintaining the MF and ensuring that it is kept up-to-date throughout its lifecycle.


In Canada, an NHP-MF serves the same purpose and follows a similar submission process as that of a Drug Master File (DMF). The United States (US) also has DMFs, whereas they are referred to as Active Substance Master Files (ASMFs) in Europe – both regions do not have a MF pathway for dietary or food supplements.

The type of MF needed depends on the regulated category and information intended to be communicated to the regulatory authority. For example, Health Canada and the US Food and Drug Administration (FDA) recognize five (5) different types of DMFs, yet the European Medicines Agency (EMA) only uses one (i.e., ASMF). Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) also has a standalone MF specific to NHPs. The table below provides a summary of the different MF types across each of the three jurisdictions.


Nutrasource’s NHP & Pharmaceutical Regulatory Sciences team is well-versed in MF dossier preparation and submission to various regulatory authorities.

Our experts can help navigate between MF types and the requirements for each section. Contact us today. 



1. Drug MF


3. Drug MF

4. Drug MF

5. Drug MF

6. US Dietary Supplement

7. Drug MF

8. Active Substance Master File

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Tags: Regulatory, Dietary Supplements/Natural Health Products

VHPs in Canada: A Growing Market with a Regulated Pathway

Posted by Nutrasource on Fri, Aug 11, 2023

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Tags: Claims, Regulatory, Concept to Claim, market access, Animal Supplements

What We Saw in 2022: Key Trends

Posted by Santa Al Antwan, Regulatory Affairs Associate on Wed, Feb 22, 2023

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.


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Tags: Product Testing & Certifications, Product Marketing, Regulatory, Dietary Supplements/Natural Health Products, market access

How to Not Get Kicked Off for Non-Compliant Natural Health Products

Posted by Nutrasource on Thu, Feb 02, 2023

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, be warned - it's not as simple as setting up an account and listing your products!

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Tags: Product Marketing, Regulatory, Dietary Supplements/Natural Health Products

What you need to know about drug submissions

Posted by Paula Guerra. Regulatory Affairs Manager on Tue, Jan 24, 2023


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 must provide enough information to ensure the safety, efficacy, and quality of the drug product, showing that the benefits of the drug outweigh the risks.


Common Technical Document (CTD)

The information to be presented to the Agency is organized into five (5) modules, using the CTD format, as follows:

  • Module 1: Regional Administrative Information
  • Module 2: Quality Overall Summaries
  • Module 3: Quality, including Chemical, Manufacture and Controls (CMC) sections
  • Module 4: Non-clinical Study Reports
  • Module 5: Clinical Study Reports


Process and Timeline

Drug Submission Flowchart (6)

As seen in this flowchart, the entire regulatory journey from the initial drug application to its approval takes approximately 6 months for drugs that qualify for accelerated approval and up to 2 years for drugs that follow regular processing timelines, avoiding any delays.

Here are some key points of what happens at each stage:

  1. Pre-Submission MeetingAn option to get questions or concerns addressed by the regulatory Agency prior to filing the submission.  
  2. Submission Filing: The application must contain all the necessary information to satisfy the regulatory requirements of the appropriate division or directorate within the Agency.
  3. Review of the Submission: The Agency assigns a review team to evaluate the safety, efficacy, and quality of the product. Additionally, the Agency reviews the labeling of the drug product and inspects the facilities where the drug will be manufactured.
  4. Decision: If the information provided is deemed adequate, a positive decision is made, and the drug is approved to be released to the market. 
  5. Post-Marketing Activities: Post-market management of the product is critical and includes activities like monitoring of adverse events, Phase 4 clinical trials, reporting of post- approval changes (e.g., manufacturing, labeling, stability, etc.), and risk management plans.


SGS Nutrasource offers full-service consulting in this to make sure the new drug submission process is smooth. The team of regulatory experts extensively researches, compiles, and reviews drug submissions for compliance in Canada and/or the U.S. and files the application to the appropriate Agency, helping clients to achieve regulatory confidence and market access. 

Speak to a member of our team on how we help you successfully bring your pharmaceutical to market.



Related Content - for website pages-2

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Tags: Regulatory, Dietary Supplements/Natural Health Products, market access

The “Do’s and Don’ts” of Claims Substantiation for Dietary Supplements and Natural Health Products

Posted by Santa Al Antwan, Regulatory Affairs Associate on Wed, Nov 23, 2022

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 are some major differences in regulations between the two countries.

U.S. Canada
  • Only new dietary ingredients require pre-market notification to the Food and Drug Administration (FDA)
  • NHPs are subject to pre-market approval.
  • Dietary supplements are regulated post-market, as a subset of foods, and restricted to products taken by mouth (e.g., capsules, tablets, soft gels, gel caps, powders, bars, gummies, liquids, etc.)
  • NHPs are considered a subclass of drugs, and can be formulated in pharmaceutical-like dosage forms (e.g., elixir, suppository, topical ointment, etc.)

As a result, the potential claims for dietary supplements and NHPs vary significantly with most dietary supplements carrying structure/function claims and NHPs ranging from low- to high-risk health claims.

Given the complexity and nuances between jurisdictions, SGS Nutrasource’s regulatory experts will help you understand how to approach claims substantiation and apply these best practices to both product types. 


Label Claims for Dietary Supplements – in US and Canada

  • A health claim (both U.S. & Canada): used to indicate the beneficial effect of a product in reducing the risk of a disease or health-related condition when used in accordance with its recommended conditions of use.
  • A 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 supplements may make health claims; however, they are subject to pre-market review and authorization by the U.S. FDA. Structure/function claims are not pre-approved per se, but a notification must be submitted to the FDA no later than 30 days after the dietary supplement is first marketed.

In Canada, an NHP must have a recommended use expressed via its health claim, and that health claim must have a health context in order to attain Health Canada approval in the form of a Natural Product Number (NPN). Therefore, given the conditions under which NHPs are screened, reviewed, and subsequently approved, they cannot carry structure/function claims.


This flowchart summarizes the different categories of claims in the U.S. and Canada.

Claims flowchart

Constructed using guidance documents from the FDA and Health Canada.


Simply put, in order to avoid unnecessary and potentially costly consequences, we need to know the do’s and don’ts to consider when assessing a product’s claims potential.


Claims dos and donts (1)


SGS Nutrasource offers claims substantiation consulting to ensure regulatory compliance for your product label in line with the various geographical jurisdictions.

Speak to a member of our team on how we can support your regulatory needs.



Related Content - for website pages (1)-1


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Tags: Claims, Regulatory, Dietary Supplements/Natural Health Products, market access

New Labelling Requirements for Natural Health Products

Posted by Nidhi Joshi, Regulatory Affairs Manager on Thu, Aug 11, 2022


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.

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Tags: Regulatory, Dietary Supplements/Natural Health Products

FDA Announces New Policy for New Dietary Ingredient Notifications (NDINS) - An Ingredient Manufacturer Must Read!

Posted by Nutrasource on Wed, Jun 29, 2022

Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures. Read on to learn more.

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Tags: Product Testing & Certifications, Regulatory, Concept to Claim, ingredients, market access