Marketed Health Products Directorate

The Marketed Health Products Directorate (MHPD) works to assure that Health Product and Food Branch (HPFB) programs take a consistent approach to post-approval safety surveillance, assessment of signals and safety trends and risk communications concerning all regulated marketed health products.

Activities of the MHPD include:

• monitoring and collecting adverse reaction and medication incident data;
• reviewing and analysing marketed health product safety data;
• conducting risk/benefit assessments of marketed health products;
• communicating product related risks to health care professionals and the public;
• overview of regulatory advertising activities;
• providing policies to effectively regulate marketed health products;
• active surveillance and drug effectiveness project.

Offices and Bureaux:

MHPD is composed of the following areas:

• Director General's Office
• Office of Risk Management and Science
• Bureau of Strategic Initiatives and Planning
• Marketed Biologicals, Biotechnology and Natural Health Products Bureau
• Marketed Health Products Safety and Effectiveness Information Bureau
• Marketed Pharmaceuticals and Medical Devices Bureau
• Therapeutic Effectiveness and Policy Bureau

MHPD's Announcements

• 2011-10-25 - Updates to the Guidance Document for Mandatory Problem Reporting for Medical Devices and the Mandatory Medical Device Problem Reporting Form for Industry
• 2011-03-17 - Announcement - Release of the Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products
• 2011-03-03 - Notice - Publication of an amendment to the Adverse Drug Reaction Reporting Regulations in Canada Gazette Part II
• 2010-12-09 - Guidance Document - Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising
• 2010-09-30 - Announcement - Issuance of the Position Statement on the Preclearance and Complaint Adjudication of Exempted Natural Health Product Advertising Materials
• 2010-03-30 - Announcement - Issuance of the Interim Guidance on Fair Balance in Direct-to-Consumer Advertising of Vaccines
• 2009-11-13 - Announcement - Launch of the Re-designed Canada Vigilance Adverse Reaction Online Database
• 2008-07-16 - Release of Guidance Document: Description of Current Risk Communication Documents for Marketed Health Products for Human Use
• 2007-10-01 - Canada Vigilance - A New Name for the Canadian Adverse Drug Reaction Monitoring Program
• 2005-05-26 - Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Online Query and Data Extracts

MHPD's Publications

• 2009-12-18 Marketed Health Products Directorate - Pamphlet
• 2009-08-25 Marketed Health Products Directorate: Retrospective - The First Five Years | 2002-2007
• 2008-09-05 What We Heard - Key Findings from the 360° Assessment of Stakeholder Relations
• 2008-01-18 Federal Regulatory Post-Market Surveillance Strategy - Planning for our Future: Federal Regulatory Post-Market Surveillance Strategy 2007-2012
• 2007-12-21 Federal Regulatory Post-Market Surveillance Strategy - Planning for Our Future: Highlights of the Federal Regulatory Post-Market Surveillance Strategy 2007-2012

See also:

• MedEffect Canada
  • Adverse Reaction Information
  • Advisories and Warnings
• Regulatory Requirements for Advertising

Contact the Marketed Health Products Directorate

To receive more information about us and our programs, contact the Marketed Health Products Directorate (MHPD).

Our core hours of operations are: Monday - Friday 8:00 a.m. to 5:00 p.m. (Eastern Time)