Health Canada, Health Products

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Health Canada, Health Products Food Branch
Therapeutic Products Directorate

• PRA 700

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Mission of Health Canada

• To help the people of Canada maintain and improve
  their health
• Covers 3 broad areas
• www.hc-sc.gc.ca

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Organizational Chart for Health Canada
Minister
Science Advisory Board
Canadian Institutes of Health Research
Hazardous Materials Information Review Commission
Patented Medicines Prices Review Board
Chief Scientist
DM
Pest Management Regulatory Agency
Health Products Food Branch (formerly HPB)
Health Policy Communications
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Health Products Food Branch (HPFB)(formerly
Health Protection Branch (HPB)

• What does HPFB do?
• Promote good nutrition and informed use of drugs,
  food and natural health products
• Maximize the safety and efficacy of drugs, food,
  natural health products, medical devices,
  biologics and related biotechnology products in
  the Canadian marketplace and health system

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Health Products Food Branch (HPFB)(formerly
Health Protection Branch - HPB)

• Major Programs
• Therapeutic products (medical devices drugs)
• Food, including all Health Canada nutrition
  activities
• Natural health products
• Biologics and genetics
• Office of Consumer Affairs and Public Involvement
• Office of Biotechnology and Science
• Health Products and Food Litigation Secretariat

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Therapeutic Products Directorate (TPD)

• The national authority which regulates drugs,
  medical devices and other therapeutic products
  used in Canada
• Supported by the contributions of more than 700
  scientists, doctors, technicians, administrators,
  inspectors, and managers
• Dedicated to helping Canadians maintain and
  improve their health

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TPD Organizational Chart
Director
Executive Services
Strategic Planning, Communications Quality
Continuing Education
Drug Analysis Service
Management Services
MEDICAL DEVICES
PHARMACEUTICAL ASSESSMENT
POLICY COORDINATION
LICENCE POLICY ASSESSMENT
www.hc-sc.gc.ca
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Regulatory Scope of TPD

• The prime responsibility of the TPD is the
  regulation of therapeutic, preventative and
  diagnostic products in Canada
• Definitions, regulations, guidelines etc. are all
  derived from the Food Drugs Act and Regulations

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QUESTIONS ANSWERS
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Food and Drugs Act

• Food and Drug Regulations
• PRA700

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Food and Drugs Act

• Applies to all food, drugs, cosmetics and medical
  devices sold in Canada whether manufactured or
  imported
• Specify safety, compositional, nutritional and
  labelling requirements for food

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Food and Drugs Act

• New drugs cannot be marketed in Canada with a
  Notice of Compliance (NOC) from HC
• NOC verifies that the manufacture and sale of the
  new drug is in compliance with the Food and Drugs
  Act and regulations
• Medical devices, cosmetics and old drugs must
  also meet departmental safety standards

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Organization

• Food and Drugs Act
• Part A - Administration
• Part B - Food
• Part C - Drugs
• Divisions 1-10
• Part D - Vitamins, Minerals and Amino Acids
• Part E - revoked

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Organization

• Part G - Controlled Drugs
• Part J - Restricted Drugs

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Organization (continued)

• Regulations Respecting Cosmetics
• Schedule F
• Index of Food Additives
• Processing and Distribution of Semen for Assisted
  Conception Regulations
• Medical Device Regulations

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Organization (continued)

• Date in margin
• date of implementation

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Codes

• A.01.001
• A - Part A
• 01 - Division 1
• 001 - Regulation 1

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FOOD DRUGS ACT
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FOOD DRUGS ACT

• Part I-IV
• Schedules A-H

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Part I

• Food, Drugs Cosmetics and Devices
• General
• Food
• Drugs
• Cosmetics
• Devices

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GROUP ACTIVITY - FOOD, DRUGS, COSMETICS DEVICES

• DISCUSSION 1 ACTIVITY WOULD GO HERE

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Part II

• Administration and Enforcement
• Inspections, Seizure and Forfeiture
• Analysis
• Regulations
• Offences and Punishment
• Exports

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GROUP ACTIVITY - REGULATIONS

• DISCUSSION 2 ACTIVITY WOULD GO HERE

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• Part III
• Controlled Drugs - repealed
• Part IV
• Restricted Drugs - repealed

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Schedules A-H

• Schedule A
• Diseases, disorders or abnormal states for which
  treatments, preventatives or cures cannot be
  advertised or sold to the general public
• Schedule B
• Lists acceptable pharmacopoeial references

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Schedules A-H (continued)

• Schedule C
• Drugs, other than radionuclides, sold or
  represented for use in the preparation of
  radiopharmaceuticals
• Schedule D
• Allergenic substances used for the treatment of
  diagnosis of allergic or immunological diseases

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Schedules A-H (continued)

• Schedule F
• Divided into Part I II
• Part I lists those drugs which require a
  prescription for their sale when intended for
  either human or animal use
• Part II lists drugs that are required to be sold
  on prescription only when intended for use in
  humans and which do not require a prescription
  when intended for veterinary use

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Schedules A-H (continued)

• Schedule G
• Lists Controlled Drugs
• Schedule H
• Lists Restricted Drugs

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QUESTIONS ANSWERS