Whether you are seeking submissions for Drugs,
notification for Novel
food , you will find QMRS services unique and matchless
We spend more time for the
preparation of well structured submissions to
secure timely product licensing
take full responsibility to manage the communications with Health
HEALTH CANADA REGULATIONS
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.
Canada, there are more than 22,000 pharmaceutical products and 40,000
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
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
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
do have an outstanding experience on the requirements of Canadian
Generic Drug submissions. Clients usually ask these two questions:
the US ANDA dossier closer to Canadian dossier?
And can the reference product be from USA?
The answers are:
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 stringent process) compared with
US submissions. However, Module 3 and 5 are similar.
For the Canadian submissions, we need to have at least two
manufacturing batches (one must be Bio Batch) with minimum 100,000
batch size and with six months stability at the time of submission,
whereas in US only one batch (Bio batch) is required with three months
In terms of Bio studies; Canada can accept the US submitted Bio study,
but it must be 100% similar product with respect to color, shape, size
order for a drug product purchased in another country to be considered
acceptable for use as 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, QMRS can prepare (Module 1 and 2 in
particular)), compile, and submit the registration package as per HC
NATURAL HEALTH PRODUCTS
Canada, natural health products (also referred to as complementary
medicines or traditional remedies) are subject to the Food and Drugs Act
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 a
homeopathic medicine, by the letters DIN-HM.
per Section (5) of the Natural Health Products Regulations, Health
Canada requires two types of reports to be submitted, with the product
The first is the Evidence Summary Report, which is designed to provide
the HHP assessor with information about the products safety and
efficacy. And the second is the Quality Summary Report.
EVIDENCE SUMMARY REPORT
Experience has shown that HC accepted evidence of finished product
safety and efficacy that based on three pillars:
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
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
Quality of the Evidence and
To determine the quality of evidence from various studies, HC consider
objectives, the methods, and outcome measures were clearly defined
There was a clear
description of the inclusion and exclusion criteria
methods of statistical analysis were adequate and well-described
The study was
peer-reviewed, randomized; double-blinded, and there at least one
information was described The medicinal ingredient in the study
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.
QMRS Consulting Services
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
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.
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.
For more information about QMRS NHPs licensing, please contact us by
telephone at (613) 526 0471, by fax at (613) 526 0558, or by email
(firstname.lastname@example.org) and promptly, we
would be pleased to answer you
The basis for the regulatory authority for the Cosmetics Program comes
from the Food and Drugs Act (FDA) and Cosmetic Regulations.
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:
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
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.
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
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”.
FOOD, DRUG OR NHPs
because it masks the odour of perspiration, with or without a
Drug or NHPs,
because it suppresses the
production of perspiration.
because it moisturizes skin.
Face cream with
Sun Protection Factor (SPF) 15
Drug, because it
protects the skin from sun damage.
Food, because it
is meant for oral consumption
Food, because consumption is secondary to its
cosmetic cleansing property
(No claims on its
effects on muscles are made)
because it lubricates and maintains the integrity of the skin
remedy to speed scar healing
NHP, because a
therapeutic function has been claimed for the natural extract used
in the product.
The responsibility for the regulations dealing with foods sold in
Canada, including novel foods, is shared by Health Canada and the
Canadian Food Inspection Agency (CFIA).
Novel food means
A substance, including a micro organism, that does not have a history
of safe use as a food;
A food that has been manufactured, prepared, preserved or packaged by
a process that has not been previously applied to that food, and
causes the food to undergo a major change;
A food that is derived from a plant, animal or micro organism that has
been genetically modified
The mechanism by which Health Canada controls the sale of novel foods in
Canada is the mandatory pre-market notification requirement as set out
in Division 28 of Part B of the Food and Drug Regulations.
Manufacturers or importers are required under these regulations to
submit information to Health Canada so that a determination can be made
with respect to the product’s safety prior to sale.
is recommended that manufacturers or importers consult with the Food
Directorate if they are not sure if a product is a novel food or not, or
if they would like to discuss data requirements specific for a novel
food. This will help to determine if a notification is needed and, if
so, how to develop a safety assessment data package. Certainly, QMRS can
assist you to do so.
notification shall include a description of the novel food, together
with information respecting its development, details of the method by
which it is manufactured, prepared, preserved, packaged and stored,
details of the major change, if any, information respecting its intended
use and directions for its preparation, information respecting its
history of use as a food in a country other than Canada, if applicable,
and information relied on to establish that the novel food is safe for
the information provided in the notification for a novel food is not
considered adequate to determine the novel food’s safety, additional
data supporting the safety of the food will be required. The type of
information required to conduct the safety assessment of a novel food
will depend on a number of factors such as the nature of the food,
processing methods and the intended use.
brief, whether you are seeking Drug, NHPs, Cosmetic, or Novel Food submissions, you will find QMRS
services unique and matchless. This is not only because of our team
qualifications, but also because we spend more time for the preparation
of well structured products submissions to facilitate its screening and
subsequent approval by Health Canada
Furthermore, we usually, take full responsibility to manage and follow
up the communications with Health Canada to secure timely product
For more information about QMRS products licensing, please contact us by
phone at (613) 526 0471, by fax at (613) 526 0558, or by email
(email@example.com) and promptly, we
would be pleased to answer you.