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Whether you are seeking submissions for Drugs, Natural health products, Cosmetics, or pre-market notification for Novel food, you will find FHPD services unique and matchless.

We spend more time for the preparation of well-structured submissions to secure timely product licensing

FHPD takes full responsibility to manage the communications with Health Canada.

HEALTH CANADA REGULATIONS

BACKGROUND
Health Products and Food Branch (HPFB) is a science-based organization within Health Canada that regulates products, including pharmaceuticals, radiopharmaceuticals, biologics and genetic therapies, medical devices, natural health products, veterinary drugs, and food.
In Canada, there are more than 22,000 pharmaceutical products and 40,000 medical devices.
Health Canada’s Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use.
Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy, and quality as required by the Food and Drugs Act and Regulations.

Below, are brief descriptions of how products are regulated

A NEW DRUG SUBMISSION (NDS)

When a product makes a therapeutic claim (e.g. to prevent or treat disease), it is classified as a drug under the Food and Drugs Act and therefore requires a Drug Identification Number (DIN). Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

New drugs are commonly referred to as brand-name products because they have been created by companies and patented rather than reproduced by competitors. If, at the completion of a new drug review, HPFB concludes that the benefits outweigh the risks and that the risks can be mitigated and/or managed, the product is issued a letter known as a Notice of Compliance (NOC) and a Drug Identification Number (DIN). This allows the manufacturer to sell the product in Canada.

If upon completing its review, HPFB finds that the submission fails to comply with the requirements set out in the Regulations, it will issue a Notice of Non-Compliance (NON). This notice outlines HPFB's concerns and generally requests additional information.

GENERIC DRUGS (ANDS)

An Abbreviated New Drug Submission (ANDS) is used for a generic product. The submission must meet the same quality standards as an NDS and the generic product must be shown to be as safe and efficacious as the brand-name product. An ANDS includes scientific information that shows how the generic product performs compared with the brand-name product, as well as providing details on the production of the generic drug, its packaging and labelling. The generic drug must be shown to deliver the same amount of medicinal ingredient at the same rate as the brand-name product. This comparison is usually done through comparative bioavailability studies.
A Drug Identification Number (DIN) application must be filed for those products that do not meet the definition of a 'new drug'. 

In FHPD, We do have outstanding experience on the requirements of Canadian Generic Drug submissions. Clients usually ask these two questions:
Is the US ANDA dossier closer to the Canadian dossier?
And can the reference product be from the USA?
The answers are:

1) For the Canadian Submission we need to submit the dossier in Common Technical Document (CTD) format. In the CTD format Module 1 and Module, 2 are different in Canadian (rather a stringent process) compared with US submissions. However, Module 3 and 5 are similar.

2) For the Canadian submissions, we need to have at least two manufacturing batches (one must be Bio Batch) with a minimum of 100,000 batch size and with six months stability at the time of submission, whereas in the US only one batch (Bio batch) is required with three months stability data.

3) In terms of Bio studies; Canada can accept the US submitted Bio study, but it must be 100% similar product with respect to colour, shape, size and weight.

4) In order for a drug product purchased in another country to be considered acceptable for use as a Canadian Reference Product, it must comply with the following criteria:

◾The drug product must be a conventional, immediate-release solid oral dosage form, i.e. tablets or capsules.

◾There is no documented evidence of bioavailability problems related to the medicinal ingredient or the drug product, or ingredients or products of similar chemical structure or formulations.

◾It must be documented that the drug product is authorized for marketing by the health authority of a country with drug assessment criteria documented to be comparable to those in Canada as required by Division 8 of the Food and Drugs Act and interpreted in Drugs Directorate guidelines and policies.

◾It must be documented that the drug product is marketed in the country of origin by the same innovator company or corporate entity, which currently markets the same medicinal ingredient in the same dosage form in Canada, or that it is marketed in the country of origin through a licensing arrangement with the innovator company or corporate entity which currently markets the product in Canada.

To summarize, if your registration package is ready for submission, we can review the dossier contents and structure before submission. We provide you with a complete report on the package completeness and adequacy. Alternatively, FHPD can prepare (Module 1 and 2 in particular)), compile and submit the registration package as per HC regulations.

NATURAL HEALTH PRODUCTS


In Canada, natural health products (also referred to as complementary medicines or traditional remedies) are subject to the Food and Drugs Act and Regulations.

Products that fall within these Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids, and essential fatty acids.

All-natural health products require a product licence before they can be sold in Canada. Obtaining a licence will require submitting detailed information on the product to Health Canada, including medicinal ingredients, source, potency, non-medicinal ingredients and recommended use. Once a product has been assessed and granted market authorization by Health Canada, the product label will bear an eight-digit product licence number preceded by the distinct letters NPN, or in the case of homeopathic medicine, by the letters DIN-HM.

As per Section (5) of the Natural Health Products Regulations, Health Canada requires two types of reports to be submitted, with the product licence application.

The first is the Evidence Summary Report, which is designed to provide the HHP assessor with information about the product's safety and efficacy. And the second is the Quality Summary Report.

NHPs EVIDENCE SUMMARY REPORT
Experience has shown that HC accepted evidence of finished product safety and efficacy that based on three pillars:

1) Strength of the Evidence The evidence to support a claim and the remaining conditions of use may be available from a variety of references. However, depending on the type of claim the evidence provided must be adequate and of adequate strength.

2) The credibility of the Evidence, Under this requirement, HC assess the credibility of the evidence from the type of references. Reference should be generally (a) Available (commercially published) (b) Widely recognized and widely used. (c) And it is the most current information or edition available

3) Quality of the Evidence and
To determine the quality of evidence from various studies, HC consider the following:

◾The study objectives, the methods, and outcome measures were clearly defined
◾There was a clear description of the inclusion and exclusion criteria
◾The methods of statistical analysis were adequate and well-described
◾The study was peer-reviewed, randomized; double-blinded, and there at least one control group. Risk information was described The medicinal ingredient in the study adequately identified

QUALITY SUMMARY REPORT

This is to provide the assessor with the finished product specifications. Natural health products Directorate (NHPD) encourages applicants to devote sufficient time to prepare clear and precise quality report.

FHPD Consulting Services
We noticed that not many applicants meet the above parameters in their products licensing submissions. Such matter, usually leads Health Canada to issue a very lengthy Information Request Notice (IRN), which result in a delay of product licensing, if not refusal of the product application.
Since the implementation of the Natural Health Products (NHPs) regulations, we have prepared and submitted many applications, which cover a wide range of products that include Homeopathic nasal spray, dietary supplements (such as energy drinks), topical ointments and creams, and disease specific products in various dosage forms.
We also saw a number of Information Request Notice (IRN) that some applicants received from Health Canada. Therefore, we become very knowledgeable on how HC assess (review) the product licensing package.

COSMETIC PRODUCTS

The basis for the regulatory authority for the Cosmetics Program comes from the Food and Drugs Act (FDA) and Cosmetic Regulations.
It is the responsibility of the manufacturer, importer, or distributor to ensure the cosmetic products they sell comply with the FDA and Cosmetic Regulations and other associated legislation.

Notification is a mandatory requirement for the sale of cosmetics in Canada, according to section 30 of the Cosmetic Regulations. This entails submitting a fully completed Cosmetic Notification Form (CNF) to Health Canada within the first 10 days a cosmetic is available for sale.
The completed CNF provides specific product information, including the Purpose of the cosmetic, Form of the cosmetic (e.g. gel, solid, liquid, etc.), Ingredients of the cosmetic and concentrations of the ingredients (ranges specified in the Cosmetic Regulations)

All cosmetics imported into Canada must be in compliance with the Cosmetic Regulations. In some cases, shipments may be seized by the Canada Border Services Agency (CBSA) if notification has not been completed pursuant to section 30 of the Cosmetic Regulations.

Product Classification:
If you want to know whether your product is a cosmetic, food, drug or NHP, please see the following table, which shows examples of how some products are classified. Also, for more information on NHP/DRUG Classification, please visit the following link, which provides a “Summary of NHP/DRUG Classification of TPD Category IV Labelling Standards Ingredients”.

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/list_mono4_e.html