Ahmed Abouelnour

Overview

What are NHPs?

Regulatory Background

NHPs Health Canada Approval Requirements

& Pathway

Herbal Medicines Challenges

Canadian and International Markets

SWOT Analysis

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.

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.

Health Canada Regulatory Requirements

• Independent on-site or Health Canada audit

• NHP manufacturers, packagers, labelers and importers Site Licensing

• Health Canada: Assessment of 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-Benefit Assessment

Post Marketing Products Safety

Monitoring

• When necessary to support clinical evidence Clinical Trials

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

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

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) .

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.

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

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.

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

Canadian & USA Market USA: Vitamins > Glucosamine > Herbal remedies >

Antioxidants > Melatonin

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).

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

SWOT