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About Health Canada

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

  • 2016-06-30 - NOTICE: Guidance for Industry on the Design of Safe and Clear Health Product Labels
  • 2012-07-13 - Health Products and Food Branch International Pharmacovigilance Symposium
  • 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:

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)