Overview of Natural Health Products regulations and market in Canda

1. Ahmed Abouelnour

2. Overview
What are NHPs?
Regulatory Background
NHPs Health Canada Approval Requirements
& Pathway
Herbal Medicines Challenges
Canadian and International Markets
SWOT Analysis

3. What are NHPs
 According to Health Canada, NHPs are defined as:
1. Vitamins and minerals;
2. Herbal remedies;
3. Homeopathic medicines;
4. Traditional medicines, such as traditional Chinese medicines;
5. Probiotics; and
6. Other products, such as amino acids and essential fatty acids.
 Regulated by Health Canada Natural Health Products
Regulations -> Product License, site licensing, Good
Manufacturing Practices (GMPs), Packaging and Labelling.
 Implemented since 2004.

4. Regulatory Background
2004: Natural Health Products Regulations
2010: Backlog, NHP Unprocessed Product Licence
Applications Regulations (NHP-UPLAR)
2012: New Approach to Natural Health Products
February 2013, Health Canada completed the review
of all unprocessed applications
81,629 Licensed products by Health
Canada till the end of Q1, 2014.

5. Health Canada Regulatory
Requirements
• Independent on-site or Health Canada audit
• NHP manufacturers, packagers, labelers and importersSite Licensing
• Health Canada: Assessmentof product's benefits and risks
• Class I: High level of certainty
• Class II: Medium level of certainty
• Class III: Low level of certainty
Product
licensing
• Companies : Prepare & maintain summary reports of adverse reaction data
on an annual basis for each product
• Health Canada: Risk-BenefitAssessment
Post Marketing
Products Safety
Monitoring
• When necessary to support clinical evidence
Clinical Trials

6. Health Canada Approval Pathway
 There are 7 types of Product License
Applications (PLAs):
1. Compendial: Monograph
2. Traditional Claim
3. Non-Traditional Claim
4. Homeopathic : Monograph
5. TPD Category IV/Labelling Standard
6. Homeopathic DIN
7. Transitional DIN

7. Health Canada Approval Pathway
NHP
Assessment
Class I Class II Class III
MUST comply with all
parameters of
an individual
NNHPD monograph
• "Compendial"
• "Homeopathy
Monograph"
"Traditional", "Non-traditional", "Homeopathic"
and "Category IV Monographs / Labelling
Standards“
According to Risk

8. Health Canada Approval Pathway
Class I Products:
 MUST comply with all parameters of an individual NNHPD
monograph.
 Can be "Compendial" or "Homeopathy ”.
 Product License (PL) within ten (10) business days.
 E.g.: Certain probiotics, carbon dioxide-releasing laxatives,
diaper rash products and thyme Products (See link of all
monographs) .

9. Health Canada Approval Pathway
Class II Products: Can be "Traditional“ or "Non-
traditional” claims, such as:
1. Combination of NNHPD monographs, as well as "Homeopathic
with Non-Specific Claim" and "Category IV Monographs /
Labelling Standards“(See link of all monographs) .
2. Traditional Chinese Medicine (TCM) products identical to a
pharmacopoeia formulation .
3. Any fruits or vegetables listed in the Canadian Nutrient File
up to a daily dose of 10 g (of crude material or quantity crude
equivalent for non-standardized extracts).
Product Licence within thirty (30) calendar days of receipt
of electronic PLA.

10. Health Canada Approval Pathway
Class III Products: Can be "Traditional“, "Non-
traditional” or "Homeopathic with a Specific Claim”, such
as:
1. Innovative products with partially or completely novel safety
and efficacy profiles.
2. Applications partially referencing monograph information, but
still requiring some assessment.
3. Applications containing a mixture of monograph ingredients
and additional supporting evidence. For example, a dosage form
or route of administration not indicated on the monograph(s)
that requires further assessment.
Screening
(30 Calendar Days)
Assessment
(180 Calendar Days)
Product
License

11. Challenges of Herbal Medicines
 Herbal Medicines (HMs) are a part of NHPs.
 Medicinal effect is considered due to complex range of
constituents.
 Each Herb -> different sources (different cultivation) ->
variability of constituents-> variability of therapeutic effect.
 So, regulatory authorities try to set
standards.

12. Canadian & USA Market
 Three in four Canadians
use natural health
products and a third use
them every day.
 Vitamins > Omega3 >
Herbal remedies >
Antioxidants >
Echinacea >
Homeopathic medicines

13. Canadian & USA Market
 USA: Vitamins > Glucosamine > Herbal remedies >
Antioxidants > Melatonin

14. International Trade Certificate (ITC)
 A document which speaks to the regulatory
status of a natural health product (NHP) in
Canada and/or the Canadian manufacturing,
packaging, and/or labeling site to help facilitate
access to Canadian-made NHPs in foreign
markets.
 To facilitate exportation to better meet industry
demand.
 More Third-Party Issuance of ITCs (September,
2013).

15. SWOT Analysis
Strength
-Approval time (Class I & II)
-Export Market (Health Canada
reputation)
-Variety of product options
Opportunities
-Export Market (Health
Canada reputation)
Weakness
-Class I & II: less innovation opportunities
Class II: Long time process (210 days)
Threats
-Market competition (Class I > Class II)
-Refusal of Class III
- Efficacy variability in Herbal Medicines
SWO
T