Download Interim Notification Pilot Program Veterinary Drugs Directorate

Health Canada’s Approach to
Low Risk Veterinary Health Products:
Interim Notification Pilot Program
Veterinary Drugs Directorate-Health Canada
Presented to the VICH Outreach Forum October, 2015
Health Canada/Veterinary Drugs Directorate
Mandate
Health Canada is responsible for protecting human and
animal health and the safety of Canada's food supply.
Through the Veterinary Drugs Directorate, Health
Canada evaluates and monitors the safety, quality and
effectiveness, sets standards and promotes the prudent
use of veterinary drugs administered to food-producing
and companion animals.
http://www.hc-sc.gc.ca/dhp-mps/vet/index-eng.php
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Health Canada/Veterinary Drugs Directorate
Act , Regulations & Guidelines
• The Veterinary Drugs Directorate (VDD) applies the Food
and Drug Regulations under the authority of the Food
and Drugs Act
• Data requirements according to international
guidelines for veterinary drugs
• VICH
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Health Canada/Veterinary Drugs Directorate
HC-VDD website: http://www.hc-sc.gc.ca/dhpmps/vet/index-eng.php
Note: Health Canada does not have authority over the
practice of veterinary medicine (Provincial jurisdiction)
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Veterinary Drug Regulation/Approval
Current process
Pre-market approval requirements:
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Manufacturing and quality controls
Animal safety data
Efficacy data
Human safety data (Food producing animals)
http://www.hc-sc.gc.ca/dhpmps/vet/legislation/guide-ld/vdd-guide-ands-padneng.php
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Low-risk Veterinary Health Products
Issues (1)
• Increased demand for low-risk veterinary health products
such as vitamins, minerals, homeopathics, probiotics and
botanical products among others
• Members of the industry faced challenges in meeting
current regulatory requirements (not adapted to these
products)
• Drug regulatory framework – one size fits all, regardless of
risk
Low-risk Veterinary Health Products
Issues (2)
• A number of these products marketed or imported for
sale in Canada without regulatory scrutiny or
appropriate market authorization
• Quality, safety and efficacy unknown to Health Canada
• Regulatory compliance action in Canada / at the border
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Interim Notification Pilot Program:
New Option
• 2012: A voluntary option of simplified registration for LowRisk Veterinary Health Products for companion animals
• Health Canada sets standards - low risk products only
• Notified products have a Notification Number on label (ex.
NN.1A2B)
• Health Canada would not prioritize the enforcement of the
regulatory requirements for such products
•
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Interim Notification Pilot Program:
Development (1)
Standards developed in consultation with industry and
science experts
• Recommendation of the Expert Advisory Committee (2010)
• INPP consultation - strong stakeholder support (2011)
• Flexible approach to product regulation
• Reduction of administrative burden for Industry
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Interim Notification Pilot Program:
Development (2)
• Administrative process in collaboration with third party
administrator
• Customized Database, e-forms
• List of Admissible Substances
• Researched over 5500 ingredients (vitamins, minerals,
homeopathic, herbal, excipients etc)
• Harmonization
• Information from other directorates, agencies (eg NHPD, CFIA,
Food) and international resources (eg US GRAS, EU directives)
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Interim Notification Pilot Program
Design (1)
• Only for products intended for use in cats, dogs and
horses
• Great interest from stakeholders on an approach for
food producing animals
• Only pre-cleared ingredients
• Only oral /topical/otic (ear) route of administration
• Only general health claims
Interim Notification Pilot Program
Permitted claims
General Health Claims
• Refer to the maintenance of normal physiology, not to its
modification
• “Helps maintain”, “supports”, “enhances”, “has a role in”,
“contributes to”
• Not associated with a specific disease, condition or injury
• Structure or physiological function
• “Maintains joint and bone health” vs “Treats osteoarthritis”
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Interim Notification Pilot Program
Design (2)
• Health Canada sets eligibility standards (Safety,
Efficacy, Quality)
• Sponsor attests to compliance (evidence on
hand)
• Program administered by Third Party
• verifies eligibility
• issues NNs
• on fee-for-service basis
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Interim Notification Pilot Program:
Outcomes(1)
• 700+ Notified Products since March 2012 (642
active)
• 5325 ingredients permitted with qualifications
~3800 Homeopathic
~750 Non-Medicinal
~135 TCM
~640 Active (plant, animal, chemical)
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5600
700
5400
600
5200
500
5000
400
4800
300
4600
200
4400
100
4200
0
Tuesday, September 1, 2015
Wednesday, July 1, 2015
Friday, May 1, 2015
Sunday, March 1, 2015
Thursday, January 1, 2015
Saturday, November 1, 2014
Monday, September 1, 2014
Tuesday, July 1, 2014
Thursday, May 1, 2014
Saturday, March 1, 2014
Wednesday, January 1, 2014
Friday, November 1, 2013
Sunday, September 1, 2013
Monday, July 1, 2013
Wednesday, May 1, 2013
Friday, March 1, 2013
Tuesday, January 1, 2013
Thursday, November 1, 2012
Saturday, September 1, 2012
Sunday, July 1, 2012
Tuesday, May 1, 2012
Thursday, March 1, 2012
INPP Stats
No of Substances
Notified Products
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Interim Notification Pilot Program:
Outcomes(2)
• Use of custom made software
• Database and e-forms- Product Notification, New
Substance Application and Adverse Event reporting
(interconnected)
• Tested and fine-tuned registration model
• Potential to be expanded to food producing animal
products in the new regulatory framework
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Interim Notification Pilot Program:
Benefits (1)
1. Increased general safety
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Low risk ingredients only
Knowledge of manufacturing site (traceability/recalls)
Proper labelling/manufacturing standards
Adverse event reporting
In/out system (Regulations still apply)
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Interim Notification Pilot Program
Benefits (2)
2. Increased access to Low-risk products for
animals
• Easier/faster process - reduced requirements/less
costly
• Low priority for regulatory compliance enforcement
by Health Canada
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Interim Notification Pilot Program:
Benefits (3)
3. Reduced burden and cost for client
• Simple registration process
• Reduced requirement for evidence data
4. Reduced time to market for new products
• 1-4 weeks vs 300 days for conventional products
5. No increase in government resources
• Administration by third party
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Interim Notification Pilot Program:
Summary
Reduced administrative and financial burden on
Industry without compromising health and
safety of Canadians and animals
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Interim Notification Pilot Program:
More info
www.lrvhp.ca
or
http://www.hc-sc.gc.ca/dhp-mps/vet/issuesenjeux/notification-declaration-eng.php
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