Peter Hannigan Natural Resources Canada Geological Survey of Canada – Calgary
Natural Health Products Canada
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Transcript of Natural Health Products Canada
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Ahmed Abouelnour
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Overview
What are NHPs?
Regulatory Background
NHPs Health Canada Approval Requirements
& Pathway
Herbal Medicines Challenges
Canadian and International Markets
SWOT Analysis
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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.
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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.
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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
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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
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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
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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) .
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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.
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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
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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.
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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
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Canadian & USA Market USA: Vitamins > Glucosamine > Herbal remedies >
Antioxidants > Melatonin
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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).
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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