Transcript Food and Drug Regulations

Future of Consumer Health Product
Regulation
WSMI AFAMELA Conference on Self-care and
Self-medication, October 5th 2015
Karen Proud, President
Consumer Health Products Canada
Spectrum of Products under the Food
and Drug Regulations
Which one is the natural health
product?
Natural Health
Product Regulations
Food and Drug Regulations
Which one is a cosmetic?
Food and Drug Regulations
Cosmetic
Regulations
Natural Health
Product Regulations
Which one is a drug?
Canadian Consumer Product
Protection Act & Regulations
Food and Drug
Regulations
Natural Health
Product Regulations
Minister announces Consultation on a
Consumer Health Product Framework
June 9 2014
• Lower risk products are
to be separated from Rx
drugs and are to move
under a separate
framework for consumer
health products
• Appropriate oversight
based on risk
Consumer Health Products:
OTCs, NHPs, Cosmetics,
Disinfectants
– Consistent and aligned
approach to regulation
• Safety is 1st priority
• Reduce red tape where it
makes sense
Minister of Health Rona Ambrose
Consumer Health Product Framework
OTCs, NHPs, cosmetics & disinfectants
*New*
Nonprescription
drug
Regulations
Policies & Guidance
documents
Product
Reclassification
Decisions
Operational
Improvements
Why are new OTC Regs needed?
 CHPs are regulated under several sets of regulations.
 Food and Drug Regulations, Natural Health Product Regulations, Cosmetic
Regulations
 Some requirements are considerably more stringent than others,
products of similar risk can be subject to very different requirements.
 Food and Drug Regulations are not flexible enough to account for a drug's
relative benefit, harm and uncertainty profile for lower risk products like OTCs.
 OTCs are subject to disproportionate requirements
 The best elements of the Food and Drug Regulations combined with
experience gained from administering regulations such as the Natural
Health Products Regulations will inform the creation of a modern,
comprehensive and risk-based set of regulations for OTCs.
Big Picture Impact
 Health Canada recognizes the value of self-care and acknowledges the
evolving health landscape and increasing consumer demand for more
self care options.
 Health Canada recognizes the economic benefits of self care.
 “need to reduce overall healthcare system costs by promoting self-care options”.
 Calls for an integrated governance approach to consumer health
products that brings together Health Canada, provincial and territorial
governments and stakeholder to address:
 point of sale issues,
 ensure consumer access to safe products, and;
 to promote informed self-care and the need for self-care options.
Highlights
 Risk-based regulations that are separate from the Rx Drug Regulations.
 (Ie. no more “new drug” vs. “old drug” paradigm)
 Regulatory approach recognizes the benefits, harms and uncertainties by
considering the nature, intended use and exposure of the product.
 Oversight proportional to the type and amount of evidence submitted that
requires review.
 Automated licensing for products to streamline review for applicants attesting to precleared information (ie. monographs, labeling standards, acceptable ingredient lists, test
methods etc.)
 Maintaining science-based approach to OTC regulation
 Retaining the existing GMP standard and Establishment Licensing system as one
option in a risk-based approach to Establishment Licenses so OTCs can continue
to export under MRAs.
 Risk-based attestation system for brand name assessments
 Direct to consumer OTC sampling
Timeline
• CHP Framework announced in July 2014
• Consultation on the proposal for OTC Regs
closed in Feb 2015
• 2016: Potentially consult on Regulatory Text.
• Final Regulations & Coming-into-Force
2016/2017
Karen Proud
[email protected]
THANK YOU!