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Health Canada's regulatory environment spans thousands of human and veterinary drugs, vaccines, medical devices, natural health products and other therapeutic products available to Canadians, including the safety and quality of the foods they eat. The regulatory responsibility for these products is distributed among the various directorates within the Health Products and Food Branch (HPFB). For health products sold in Canada, the primary functions of the directorates are pre-market review, post-market surveillance, and regulatory compliance and enforcement.

Health Canada Post-Market Surveillance Activities

...safety, quality, efficacy, therapeutic effectiveness, cost-effectiveness...

Global Product Development

Clinical Trial Authorization

• Pre-Clinical Studies
• Clinical Trials

Limited Patient Access

Health Canada Submission Review

• Regulatory Products Submission
• Submission Review
• Market Authorization by Health Canada
  • Notice of Compliance (NOC),
  • Notice of Compliance with Condition (NOCc),
  • Medical Device License (Class II, III, IV),
  • Natural Product Number (NPN),
  • Drug Identification Number (DIN), or
  • Homeopathic Medicine (DIN-HM)
• Labelling (including the product Monograph)
• Summary Basis of Decision
  

Market Authorization

• Marketing Decisions by Drug Companies
• Price Review - Printed Medicine Prices Review Board (PMPRB)
• Common Drug Review - Canadian Agency for Drugs and Technologies in Health (CADTH)
• Listing and Reimbursement Decisions
• Public and Private Drug Plans
• Therapeutic and cost-effectiveness studies (clinical trials, research, etc)
• The Canadian Optimal Medication Prescribing and Utilization Service (COMPUS)

Under specific conditions, Health Canada’s Special Access Program may authorize the use of drugs not currently approved for sale or authorized for sale but not marketed in Canada.

Patient Access / Real World Use

Access by providers and patients through the health care system

Health Canada Post-Market Surveillance Activities

• Information gathering, monitoring and processing
• Collection and assessment of Adverse Reaction (AR’s)
• Information gathering from different sources;
• Medical and Scientific Literature,
  • Media,
  • Periodic Safety Update Report (PURS) and Phase IV studies,
  • World Health Organisations (WHO), and
  • Public Health Agency Canada (PHAC).
• Signal Detection, Prioritization and Assessment on:
  • Pharmaceuticals,
  • Medical Devices,
  • Biological (Cells, Tissues and Organs (CTO) and blood derived products),
  • Biotechnology
  • Natural Health Products.
• Re-evaluation of benefit/risk and products safety
• Utilization of Canadian and Foreign Data Sources
• Risk Management and Intervention
  • Risk Communication by
    - Public Advisories and Warnings,
    - Products Information Updates
    - Health Professional and Public Communications,
    - Notice to Hospitals,
    - Media,
    - Canadian Adverse Reaction Newsletter (CARN),
    - MedEffect™ Canada.
  • Recommendations could include:
    - Product labelling changes,
    - Withdrawal of product from marketplace,
    - Regulatory Interventions,
    - Increase Monitoring.

Pre-Market Review

Once pre-clinical studies are completed and the data shows promise of being beneficial for human use, a manufacturer can apply for authorization to conduct a clinical trial.

If the product is effective under the specified conditions of clinical trials, the manufacturer then seeks authorization to sell the product in Canada by filing a submission. HPFB scientists review the submitted information and evaluate the safety, efficacy, and quality of the product.

If the benefits outweigh the risks, therapeutic products are issued a Notice of Compliance and/or a Drug Identification Number under the Food and Drugs Act and Regulations, or receive a class II, III, or IV medical device licence under the Medical Devices Regulations. Whereas, natural health products are issued a product licence and NPN under the Natural Health Products Regulations.

After products are authorized for sale, with the exception of radiopharmaceuticals, blood and blood products, and medical devices, they are assigned one of the following types of numbers:

• Drug Identification Number (DIN),
• Natural Product Number (NPN), or
• Homeopathic Medicine Number (DIN-HM).

These numbers make it easier to identify, follow, recall, inspect, and monitor therapeutic products marketed in Canada.

Class I medical devices do not require a medical device licence since they are monitored by the Health Products and Food Branch Inspectorate through Establishment Licensing.

Post-Market Surveillance

Post-market surveillance is the continuation of the health product review process and contributes to new and up-to-date information that can only be obtained after a product is widely used under real life conditions.

Using rigorous scientific processes, MHPD evaluates reports of suspected adverse reactions (Ars) - undesirable effects due to health products - and determines whether a cause-and-effect relationship exists between the health product and the suspected AR. The MHPD conducts risk assessments and recommends appropriate measures that range from informing the public and health care professionals of product safety information, to recommending labelling changes, to removing a product from the market.

MHPD develops guidelines and implements the regulations that govern the advertising of marketed health products (except medical devices) in Canada. It also works closely with advertising pre-clearance agencies such as the Pharmaceutical Advertising Advisory Board, Advertising Standards Canada and the Broadcast Clearance Advisory to clarify standards regarding what information - including health claims and product safety information - may be included in advertising health products.

Compliance and Enforcement

The Health Products and Food Branch Inspectorate leads branch-wide compliance and enforcement activities. The Inspectorate's core functions are compliance monitoring, verification and investigation, establishment licensing, and laboratory analysis.