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Regulatory Affairs

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by

Heather Thomson

on 13 November 2014

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Transcript of Regulatory Affairs

Regulatory Affairs
Stef, Rachel & Heather
Canadian vs. American Regulations
Terms
Licensing Requirements
Evidence Requirements for Safety & Efficacy
GMPs
Adverse Reaction Reporting
Health Canada
Health Protection & Foods Branch
Therapeutic Products Directorate (TPD)
-Regulates:
Pharmaceutical drugs
Medical devices
Therapeutic Products Directorate (TPD)
Food Directorate
Natural and Non-prescription Health Products Directorate (NNHPD)
-Regulates:
Food
-Responsible for:
Establish policies
Set standards
Providing advice & info
Safety & nutritional
value of food
-Newest branch
-Regulates
Natural Health Products (NHP's)
Non-prescription & disinfectant drugs
(Federal regulations)
Health Protection Branch
(BC Regulations)
-Protect public health & safety
Air quality
Bed bugs
Drinking water & recreational water quality
Food safety & security
Personal service establishments
Radiation protection
Sewage systems
Diseases carried by mammals and insects

-Provides advice on legislation & policy issues to
Health authorities
BC Centre for Disease Control
Provincial Health Officer

Before the NNHPD...
-Products for human consumption
Regulated as food OR drug
-NHP?
Between foods & drugs
Were regulated as drugs
Not a good fit
NHP Directorate (NHPD)
-53 recommendations for NHP regulations

NHP should be it's own category
Share properties with foods & drugs
But dissimilar to both

NHP should be regulated
More stringently than foods
Less stringently than drugs

Separate NHP directorate
Regulation & governance of NHP

Staffed with experts in different areas of NHP
Ex: ND, homeopath, herbalists, etc.

Required data varies depending on type of health claim

Sustain biological diversity
Prevent depletion of valuable health resources
NHPD
-Began January 1, 2004

-Regulating authority for NHP for sale in Canada
Protect the consumer
Ensure safety, quality, & efficacy
-Includes:
Product labelling & packaging
Product licensing
Site licensing
Good Manufacturing Processes (GMP)
Evidence requirements for safety & efficacy
Adverse reaction reporting
-Now called the
NNHPD
Includes non-prescription & disinfectant drugs
Documents & regulations still in transition
Concerns about NNHPD...
-Restrict access
-Increased price
Product licensing
Taxes on NHP previously sold as foods
-Manufacturers
GMP too strict
-Adverse event reporting
-Labelling
Public wants more rather than less
2 languages
-Capacity vs workload
Enough staff to process all the applications?

Product Licensing

-Detailed info about:
Medicinal ingredients, source, dose, potency, non-medicinal ingredients, recommended use(s)

- Health Canada has assessed product
Decided it is safe, effective and of high quality
-Look for 8 digit on label!
Natural Product Number (NPN)
Homeopathic Medicine Number (DIN-HM)
Product reviewed & approved by Health Canada
-
Exception numbers
EN-XXXXXX
Product hasn't been FULLY evaluated
Initial assessment completed
Allow access to full range of NHP
While full assessment completed


Evidence Requirements
-Safety, efficacy & health claims
Need proper evidence

-Differs for
Modern health claims
Traditional use claim
Labelling
Site Licensing
-Applies to all:
Canadian manufacturers, packagers, labellers, and importers of NHP

-
Must maintain
Proper distribution records
Proper procedures for
Product recalls
Handling, storage and delivery of their products
GMP requirements

GMP
-
Proper standards & practices

for
Testing, manufacture, storage, handling, distribution

-Ex:
Sanitation program
Quality assurance
Sterile products
Lot or batch samples
Recall reporting

Who does this concern?
-
Applies to
Any person or company that
Manufactures, packages, labels &/or imports NHP for commercial sale in Canada

-
Doesn't apply to
Health care practitioners who compound products on an INDIVIDUAL basis for their patients
Retailers of NHP
Adverse Reaction Reporting
-Product license holders must
Monitor all adverse reactions related to their product
Report serious adverse reactions to Health Canada


Food Regulations
-Regulated under
______
Directorate

-Because we aren't all about supplements!
-Important to know some of the claims on food packaging
It's time to play....
'Find your #'
-DIN
-DIN-HM
-NPN
Food
-Manufactured, sold or represented as food or drink for humans
-Chewing gum
-Any ingredient that may be mixed with food for any purpose whatever
Drug
-Any substance manufactured, sold or represented for use in:
Diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms
Restoring, correcting or modifying organic functions

Functional Food
-Similar in appearance to, or may be a conventional food
-Consumed as part of a usual diet
-Has physiological benefits &/or reduce risk of chronic disease beyond basic nutritional functions
-
Types
Fortification with vitamins &/or minerals to provide added health benefits

Addition of bioactive ingredients

Enhancement with bioactive components through plant breeding, genetic modification, processing, or special livestock feeding techniques


Natural Health Product (NHP)
-Made from natural sources
-Sold in dosage form
-Designed to
Maintain or promote health
Restore or correct human health function
To diagnose, treat or prevent disease
-Ex:
Components extracted or purified from plants
Ex: antioxidants from blueberries, others?

Products ground, dried, powdered or pressed from plant materials
Ex: echinacea, ginseng

Products produced, extracted or purified from animals or micro-organisms
Ex: essential fatty acids, enzymes, probiotics

Vitamin & mineral supplements

Canadian Health Food Association (CHFA)
The largest trade association in Canada dedicated to natural health and organic products
Mission: "Leading, empowering, and supporting our members to promote the growth and advancement of the organic and natural health products industry."
Run by board of selected voluntary members
Members: growers, manufacturers, retailers, wholesalers, distributors, and importers of natural and organic products
CHFA Activities
Conferences and trade shows for natural and organic products
Regulatory affairs
Advocate for legislative change
Facilitate meetings with Health Canada and MPs
Publish CHFA's monthly Regulatory Report
Define CHFA's official position on issues
Run "Awareness Campaign" for fair legislation of NHPs
Advocacy
Currently: a new
Natural Health Products Act
International Trade Certificates
Certified Natural Products Advisor (CNPA) course
CHFA Activities
Facebook and Twitter, blogs with lifestyle tips, lifestyle articles in online and print publications, and information on the latest research on natural health and organic products - accessible to the public
Webinars, regulatory reports, and CHFA's own research publication - accessible to members
Canadian: "natural health products"
Health Canada separates NHPs from food
American: "dietary supplements"
Dietary Supplement Health and Education Act (DSHEA) places them under the "food" category
Canadian: "pre-approval" system [proactive]
Proper evidence must support safety and efficacy of product before it is marketed
Type and amount of evidence is dependent upon proposed health claim and risks
American: "post-market reporting" [reactive]
Manufacturer is legally responsible for ensuring product safety before marketing
Evidence of safety and efficacy does not have to be provided to the FDA before or after marketing (i.e. FDA approval not required)
Exception: the inclusion of a 'new dietary ingredient'
FDA must determine a product is unsafe before it can restrict its use or take it off the market
Canadian:
Site licenses and product licenses
American:
Manufacturers are required to register with the FDA before supplement production and sales (in accordance with the Bioterrorism Act)
Canadian:
Product name
Product license number
Complete list of ingredients
Recommended use
Cautions, warnings, CIs, possible adverse effects
Special storage conditions
American:
Descriptive name stating it's a "supplement"
Name and place of business of manufacturer, packer, or distributor
Complete list of all ingredients
Net contents of product
Nutrition labelling
Illegal for labels to state product can treat, prevent, or cure specific diseases and conditions
Canadian:
Product license holders are required by NHPR to keep track of all adverse reactions associated with their product
License holders
must
report adverse reactions to Health Canada
Consumers are not required but
should
report adverse reactions to their healthcare provider and to Health Canada
American:
Manufacturers and distributors are required to record and investigate reports of adverse reactions related to their products that are reported to them directly; reports must be forwarded to the FDA
Consumers and healthcare providers can report adverse reactions online or by phone
Canadian:
Extensive regulations for NHPs to ensure safety, quality, and efficacy
American:
No equivalent regulatory organization, although the FDA established regulations in 2007
Regulations are not as tight as in Canada
Adverse Reaction Reporting
Adverse reaction: a harmful and unintended effect to a health product (any undesirable effect)
Importance of reporting:
Serious adverse effects appear in >50% of health products after they have been newly approved and placed on the Canadian market
Individuals that use the products may react differently than clinical trial subjects
Adverse reaction reports aid Health Canada in monitoring product safety profiles
MedEffect Canada:
A program that provides access to health product safety information, as well as a way for consumers and health professionals to report adverse effects to the Canada Vigilance Program via a variety of ways (online, telephone, mail, fax)
Canada Vigilance Program:
A post-surveillance program that evaluates reports of adverse effects to health products in the Canadian market
Adverse Reaction Reporting
Finale
NPN Video
Health Claims
-
Health claim
Relationship exists between consumption of a food/ingredient in the food and a person's health

-
Nutrient content claim
Ex: 'high, good source, light, free, excellent source'

-
Nutrient function claims
Ex: 'Protein -Helps build and repair body tissues'

-
Disease risk reduction claim
Link a food to reduced risk of developing a diet-related disease or condition
11 accepted claims in Canada
Ex: Ground whole flaxseed & blood cholesterol lowering
Labelling
-Chinese name mix up!
Switched up herbs because had similar Chinese names
Stephania tetrandra (fen fangjii)
Wanted this for diet pill
Aristolochia fangchi (guang fangjii)
KD failure
KD cancer

-Plantain contaminated with Digitalis
An example close to our hearts...literally
3 people died in the US

Issues
Prove it!

Expanded claims, specific claims, new formulas
– need to find evidence for claims:
Previously-published studies or
Conduct new studies

Traditional use claim
- For single ingredients – see NHPD monographs
- For combinations – need evidence of traditional use from literature

Monographs
Did you know....
Therapeutic uses often requires bigger doses than those stated on monographs......must submit evidence
Hard and lots of $$ to conduct studies
Sometimes an NPN is not required:
Compounding pharmacies
Individual teas
Individual tinctures
The Business of NPNs

Whole industry

When apply for NPN, formula goes into a publicly-accessible database

No patents for health products - only TM


Issue
-Scutellaria lateriflora substituted with Teucrium chamaedrys
-adulterated form associated with LV toxicity
-no LV toxicity with Scutellaria lateriflora (skullcap) itself

So you want an NPN?
Regulations in place to protect the consumer, the general public -> assumes "self-use"

Regulations ensure safety, QUALITY, and efficacy

Putting it all together.....
Adverse Reaction Reporting
Effects that should be reported:
Any unintended effect
Health product abuse
Overdose, associated with therapeutic use
Interactions, such as drug-NHP or NHP-food
Unusual lack of therapeutic efficacy
Reports must include:
Patient information
Adverse reaction
Name of the suspected health product(s)
Contact information of the reporter
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=eng
Full transcript