Guidance on releasing information from adverse reaction and medical device incident reports to the public: Health Canada responsibilities

On this page

• Health Canada: Access to Information and Privacy Operations Division
• Health Canada: Media Relations Unit
• Health Products and Food Branch organizations
  • Biologic and Radiopharmaceutical Drugs Directorate
  • Marketed Health Products Directorate
  • Natural and Non-prescription Health Products Directorate
  • Pharmaceutical Drugs Directorate
  • Veterinary Drugs Directorate
• Regulatory Operations and Enforcement Branch
  • Medical Devices and Clinical Directorate

Health Canada: Access to Information and Privacy Operations Division

Health Canada: Access to Information and Privacy Operations Division (AIPOD) processes requests by:

• Canadian citizens, permanent residents or any persons or corporations residing in Canada for access to government records held under the control of Health Canada in accordance with the Access to Information Act
• any persons for access to their personal information held under the control of Health Canada in accordance with the Privacy Act

Health Canada: Media Relations Unit

Health Canada: Media Relations Unit (MRU) acts as a first point of contact for members of the media seeking information about Health Canada activities and programs. The unit’s role is to:

• provide consistent, open and transparent information to members of the media
• to support the Minister, Deputy Minister and departmental spokespersons in their media relations activities

Health Products and Food Branch organizations

The Health Products and Food Branch (HPFB) is composed of many directorates whose roles with respect to adverse reaction (AR) and medical device incident (MDI) reporting are summarized here.

Biologic and Radiopharmaceutical Drugs Directorate

The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) regulates biological drugs (products made from living sources) and radiopharmaceuticals (drugs that have radioactivity) for human use in Canada.

The BRDD collects and assesses serious and unexpected clinical trial and Special Access Program adverse reaction report information for these products. The BRDD also regulates certain products to comply with specific regulations, including:

• blood and blood components (B/BCs) for transfusion and further manufacture into a drug for human use through the Blood Regulations
  • blood products are regulated under the Food and Drug Regulations
• cells, tissues and organs (CTOs) for transplantation through the Safety of Human Cells, Tissues and Organs for Transplantation Regulations
• sperm and ova for assisted human reproduction (AHR) through the Assisted Human Reproduction Act

Marketed Health Products Directorate

The Marketed Health Products Directorate (MHPD) maintains and improves the Canada Vigilance Program. This program collects, processes and assesses adverse reaction and medical device information for post-market surveillance, assessment and risk communication activities of the HPFB. Adverse reactions collected by the Canada Vigilance Program include those from:

• pharmaceutical drugs
• biologics including:
  • biotechnology products
  • B/BCs
  • CTOs
  • sperm and ova for the purpose of AHR
  • vaccines (therapeutic and diagnostic vaccines since 1965, immunization vaccines since January 1, 2011)
• radiopharmaceuticals
• natural health products

MHPD releases a sub-set of the information (without personal identifiers) from MHPD's post-market domestic adverse reactions to the World Health Organization’s (WHO) International Drug Monitoring Program on a quarterly basis.

Natural and Non-prescription Health Products Directorate

The Natural and Non-prescription Health Products Directorate (NNHPD) regulates natural health products and non-prescription drugs for sale in Canada.

Pharmaceutical Drugs Directorate

The Pharmaceutical Drugs Directorate (PDD) oversees the regulation of pharmaceutical drugs. It collects and assesses serious and unexpected clinical trial adverse drug reactions reports from both domestic and international sources. It also collects and assesses adverse reaction reports for drugs obtained through the Special Access Program.

Veterinary Drugs Directorate

The Veterinary Drugs Directorate (VDD) regulates drugs approved for use in animals and evaluates post-market adverse reaction reports and assesses signals and safety trends concerning veterinary drugs. The VDD also oversees Veterinary Health Products (VHPs) for use in food and companion animals.

Regulatory Operations and Enforcement Branch

Medical Devices and Clinical Compliance Directorate

The Medical Devices Compliance Program (MDCP) is responsible for compliance and enforcement actions related to medical devices that violate or potentially violate the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR). This includes:

• Sentinel reports
• trade complaints
• voluntary problem reports
• any establishment licence (EL) non responders
• no device licence (DL) and no establishment licence incidents
• compliance verification aspect of any mandatory problem report (MPR)