The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on: 1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality. 2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada. 3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.

1. NAME: RICHA PATEL
ROLL NO: 27
M.PHARM SEM II
REGULATORY AFFAIRS
KBIPER
REGULATORY APPROVAL PROCESS OF DRUG, COSMETIC,
NEUTRACEUTICALS AND HERBAL IN CANADA

2. How are drugs reviewed in
Canada?
• Drugs are authorized for sale in Canada once they have successfully gone
through the drug review process. This process is the means by which a
drug application is reviewed by scientists in the Health Products and
Food Branch (HPFB) of Health Canada, and on occasion, outside
experts, to assess the safety, efficacy and quality of a drug.
• Throughout the process, the safety and well-being of Canadians is the
paramount concern.

3. What is the health products and
food branch?
• Health Canada's HPFB is the national authority that
regulates, evaluates and monitors the safety,
efficacy, and quality of therapeutic and diagnostic
products available to Canadians. These products
include drugs, medical devices, disinfectants and
sanitizers with disinfectant claims.

4. What is considered to be a drug?
• Drugs include both prescription and non-prescription pharmaceuticals; biologically-
derived products such as vaccines, blood derived products, and products produced
through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals.
According to the Food and Drugs Act, "a drug includes any substance or mixture of
substances manufactured, sold or represented for use in:
a. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal
physical state, or its symptoms, in human beings or animals;
b. restoring, correcting or modifying organic functions in human beings or animals; or
c. disinfection in premises in which food is manufactured, prepared or kept.“
• Natural health products, such as vitamin and mineral supplements and herbal products
for which therapeutic claims are made are also considered drugs at the level of
the Food and Drugs Act; however, these products are regulated as natural health
products under the Natural Health Products Regulations and not as drugs under
the Food and Drug Regulations.

5. What are the steps in the review
process for a drug?
1. When a sponsor decides that it would like to market a drug in Canada, it files a "New
Drug Submission" with HPFB. This contains information and data about the drug's
safety, effectiveness and quality. It includes the results of the preclinical and clinical
studies, whether done in Canada or elsewhere, details regarding the production of the
drug, packaging and labelling details, and information regarding therapeutic claims
and side effects.
2. HPFB performs a thorough review of the submitted information, sometimes using
external consultants and advisory committees.
3. HPFB evaluates the safety, efficacy and quality data to assess the potential benefits
and risks of the drug.
4. HPFB reviews the information that the sponsor proposes to provide to health care
practitioners and consumers about the drug (e.g. the label, product brochure).

6. CONTINUE…
5. If, at the completion of the review, the conclusion is that
the benefits outweigh the risks and that the risks can be
mitigated, the drug is issued a Notice of Compliance
(NOC), as well as a Drug Identification Number (DIN)
which permits the sponsor to market the drug in Canada
and indicates the drug's official approval in Canada.
6. In addition, Health Canada laboratories may test certain
biological products before and after authorization to sell
in Canada has been issued. This is done through its Lot
Release Process, in order to monitor safety, efficacy and
quality.

7. What happens when a drug is
not approved?
• If HPFB decides not to grant a marketing
authorization, the sponsor has the opportunity to
supply additional information, to re-submit its
submission at a later date with additional
supporting data, or to ask that HPFB reconsider its
decision.

8. How long does the drug review
process take?
• HPFB has set internationally competitive
performance targets for its conduct of reviews. The
length of time for review depends on the product
being submitted and the size and quality of the
submission, and is influenced by HPFB's workload
and human resources.

9. Are some drugs reviewed more
quickly?
• HPFB has a Priority Review Process in place which
allows for a faster review to make available
promising drug products for life-threatening or
severely debilitating conditions, such as cancer,
AIDS, or Parkinson's Disease, for which there are
few effective therapies already on the market.

10. Once a drug has been approved,
how is it monitored?
• Once a drug is on the market, regulatory controls continue. The
distributor of the drug must report any new information received
concerning serious side effects including failure of the drug to produce
the desired effect. The distributor must also notify HPFB about any
studies that have provided new safety information and request approval
for any major changes to the manufacturing processes, dose regime or
recommended uses for the drug.
• HPFB conducts market surveillance, monitors adverse reaction reports,
investigates complaints and problem reports, and manages recalls, should
the necessity arise.
• In addition, HPFB licenses most drug production sites and conducts
regular inspections as a condition for licensing.

12. Regulatory process for drug in
Canada
• The exhibit shows the steps in the regulatory process for drugs in Canada, from
pre-market to post-market. The pre-market part of the process starts with pre-
clinical studies. The steps are
• Pre-clinical studies
• Clinical trials
• Regulatory product submission
• Submission review
• Market authorization decision
• Public access
• Surveillance, inspection, and investigation
• The post-market part of the process begins with surveillance, inspection, and
investigation when a drug has been made accessible to the public.

14. Submission type and their
description

19. Cosmetic
• All cosmetics sold in Canada must be safe to use and must not pose any health risk. They
must meet the requirements of the Food and Drugs Act and the Cosmetic Regulations.
• Under the Food and Drugs Act, a cosmetic includes "any substance or mixture of
substances, manufactured, sold or represented for use in cleansing, improving or altering
the complexion, skin, hair or teeth and includes deodorants and perfumes." This includes
cosmetics used by professional esthetic services, bulk institutional products (such as hand
soap in school rest rooms), as well as "handmade" cosmetics sold at craft sales or home-
based businesses.
• The Cosmetic Regulations and the Food and Drugs Act require that cosmetics sold in
Canada be manufactured, prepared, preserved, packed and stored under sanitary
conditions. The manufacturer and importer must notify Health Canada that it is selling the
product and provide a list of the product's ingredients.

21. Definitions
1. cosmetic (Section 2 of the Food and Drugs Act):any substance or
mixture of substances manufactured, sold or represented for use in
cleaning, improving or altering the complexion, skin, hair or teeth,
and includes deodorants and perfumes.
2. drug (Section 2 of the Food and Drugs Act):includes any substance or
mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder
or abnormal physical state, or its symptoms, in human beings or
animals,
(b) restoring, correcting or modifying organic functions in human beings or
animals, or
(c) disinfection in premises in which food is manufactured, prepared or
kept;

22. CONTINUE…
3. natural health product (Section 1 of the Natural Health Products
Regulations pursuant to the Food and Drugs Act):a subset of drugs
pertaining to medicinal ingredients of natural origin, defined in
the Natural Health Products Regulations as "a substance set out in
Schedule 1 or a combination of substances in which all the medicinal
ingredients are substances set out in Schedule 1, a homeopathic
medicine or a traditional medicine, that is manufactured, sold or
represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder
or abnormal physical state or its symptoms in humans;
(b) restoring or correcting organic functions in humans; or
(c) modifying organic functions in humans, such as modifying those
functions in a manner that maintains or promotes health.

23. CONTINUE…
4. personal care product ( PCP):For the purposes of this document, defined as a
substance or mixture of substances which is generally recognized by the public
for use in daily cleansing or grooming. Personal care products may fall into one
of three regulatory categories in Canada: cosmetics, drugs or natural health
products.
5. product at the cosmetic-drug interface ( PCDI):A subset of personal care
products, which are not easily distinguished as either a drug or cosmetic, as
defined in the Food and Drugs Act.
The following are the programs within Health Canada that regulate personal care
products.
• NHPD: Natural Health Products Directorate (Health Products and Food Branch)
• PSD: Product Safety Directorate (Healthy Environments and Consumer Safety
Branch)
• TPD: Therapeutic Products Directorate (Health Products and Food Branch)

24. Key features of cosmetic
regulations
MAIN FEATURES CANADA
Manufacturer has full responsibility for
safety of products
Yes
In market control by authorities Yes
Freedom to use any distribution channel Yes
Notification of products Mandatory notification of product name
and function, plus quantitative or semi
quantitative ingredients list to be
notified 10 days at least after placing
the product on the market
Quantity labeling Metric labeling mandatory. Non-metric
labeling allowed as a supplement
Identity of producer/importer on the
labels
Name and address of manufacturer or
dealer. Non-canadian address is
accepted.

25. • Please note that test-marketed cosmetics must meet all requirements of
the Food and Drugs Act and the Cosmetic Regulations. There are no
exemptions for test-marketing.
• The completed Cosmetic Notification Form (CNF) provides specific product
information to Health Canada, including:
 address and contact information of the manufacturer(s), importer(s),
distributor(s), and formulator(s)
 function of the cosmetic
 form of the cosmetic (for example, cream and gel)
 ingredients of the cosmetic
 concentration of each ingredient
Link of cosmetic notification form:
http://healthycanadians.gc.ca/apps/radar/CPS-SPC-
0007.08.html?_ga=2.121816331.1843784292.1514684415-
1959261997.1514684415

26. • There is no fee associated with the cosmetic notification process.
• The personal information provided to Health Canada is protected under the
provisions of the Privacy Act.
• Submission of the CNF does not constitute approval for sale by Health
Canada, agreement that the product is classified as a cosmetic nor that
the product complies with all legislative requirements. Manufacturers and
importers are responsible for making sure their cosmetics meet the
requirements of the Food and Drugs Act and its Cosmetic Regulations.
• If there are concerns with a submitted notification or product (for example:
unknown ingredients, missing information, safety issues, improper
classification, etc.) Health Canada will inform the responsible company of
those concerns. Failure to respond may result in compliance action.

27. Examples of cosmetics
• soaps
• artificial nail builders
• adhesives such as for artificial nails, hair extensions, etc.
• moisturizers
• tinted moisturizers (concealer)
• tattoo inks
• makeup products
• tooth whiteners
• cleansing wipes
• feminine douches

28. Examples of products that are
not considered cosmetic
• sunscreens (including makeup products with SPF)
• acne treatment
• skin whiteners or lighteners
• denture cleaners
• hand sanitizers
• artificial nails and hair extensions
• brushes
• laser treatment hair removers
• collagen or "Botox" injections
• insect repellents
• oral supplements
• room or fabric sprays
• non-prescription contact lenses

29. Information on label
• This guide covers three aspects of information appearing on
the labels of cosmetic products:
• the classification of cosmetic products (see section 3).
• required declarations that must appear on a label. These
include:
• product identity (see section 4),
• net quantity (see section 5),
• name and address of the manufacturer (see definition) (see section
6),
• avoidable hazards and cautions (see section 7), and
• ingredients (see section 8).
• sources of additional information concerning labelling
requirements (see section 9).

32. Natural health products
• Natural health products (NHPs) are naturally occurring substances that are used
to restore or maintain good health. They are often made from plants, but can also
be made from animals, microorganisms and marine sources. They come in a wide
variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and
drops.
• Natural health products, often called "complementary" or "alternative"
medicines, include:
 vitamins and minerals
 herbal remedies
 homeopathic medicines
 traditional medicines like traditional Chinese and Ayurvedic (East Indian)
medicines
 Probiotics
 other products like amino acids and essential fatty acids

33. How do I know if a product has
been authorized?
• To be licensed in Canada, natural health products must be safe, effective, of
high quality and carry detailed label information to let people make safe and
informed choices.
• You can identify products that have been licensed for sale in Canada by
looking for the eight-digit Natural Product Number (NPN) or Homeopathic
Medicine Number (DIN-HM) on the label.
• A NPN or DIN-HM means that the product has been authorized for sale in
Canada and is safe and effective when used according the instructions on the
label.

34. • To be legally sold in Canada, all natural health
products must have a product licence, and the
Canadian sites that manufacture, package, label and
import these products must have site licences.
• To get product and site licences, specific labelling
and packaging requirements must be met, good
manufacturing practices must be followed, and
proper safety and efficacy evidence must be
provided.

35. Product licensing
• All natural health products must have a product licence
before they can be sold in Canada. To get a licence,
applicants must give detailed information about the product
to Health Canada, including: medicinal ingredients, source,
dose, potency, non-medicinal ingredients and recommended
use(s).
• Once Health Canada has assessed a product and decided it is
safe, effective and of high quality, it issues a product licence
along with an eight-digit Natural Product Number (NPN) or
Homeopathic Medicine Number (DIN-HM), which must
appear on the label. This number lets you know that the
product has been reviewed and approved by Health Canada.

36. Labeling
• All NHPs must meet specific labelling requirements, to help you make
safe and informed choices about the NHPs you choose to use.
Information required on NHP labels includes:
product name
product licence number
quantity of product in the bottle
complete list of medicinal and non-medicinal ingredients
recommended use (including purpose or health claim, route of
administration and dose)
any cautionary statements, warnings, contra-indications and possible
adverse reactions associated with the product
any special storage conditions