An Overview of the Marketed Health Products Directorate

2008
ISBN: 978-0-662-48757-9 (PDF Version)
Cat.: H164-2/2008E (PDF Version)

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The Marketed Health Products Directorate (MHPD) monitors the safety, effectiveness, and quality of marketed health products in Canada including:

• prescription medications;
• non-prescription medications;
• biologics, including fractionated blood products;
• therapeutic and diagnostic vaccines;
• natural health products;
• radiopharmaceutical products;
• medical devices; and
• cells, tissues and organs.

Post-market surveillance of marketed health products is conducted by the Health Products and Food Branch (HPFB). Within HPFB, MHPD leads the coordination and implementation of consistent monitoring practices with regards to assessment of signals and safety trends, and risk communications concerning regulated marketed health products.

MHPD also leads the development of regulations for reporting adverse reactions and works closely with international organizations in the harmonization of regulatory systems to facilitate the sharing of information.

In implementing its core responsibilities, MHPD:

• collects and monitors adverse reaction and medication incident data;
• reviews and analyzes marketed health product safety data;
• conducts benefit and risk assessments of marketed health products;
• communicates product-related risks to health professionals and the public;
• oversees regulatory advertising activities;
• develops and implements policies to effectively regulate marketed health products; and
• actively monitors health product safety and therapeutic effectiveness.

MHPD's activities are supported by Health Canada's Regulatory Framework and HPFB's Public Involvement Framework, which are focussed on principles of efficiency, transparency, accountability, cooperation, and consultation.

A Strategic Approach

Since post-market activities are also distributed among various Branch partners, coordination is of prime importance for improving efficiency and consistency in the collection and analysis of post-market event information.

MHPD has developed the Federal Regulatory Post-Market Surveillance Strategy 2007-2012, which positions post-market surveillance activities as part of the continuum of marketed health product safety and effectiveness.

Key objectives of MHPD's strategy, which are closely aligned with the Branch's five-year plan, Blueprint for Renewal II: Modernizing Canada's Regulatory System for Health Products and Food, include increasing collaboration and sharing information with partners and stakeholders, rendering timely and transparent decisions, increasing public confidence, and facilitating informed health product choices.

To meet these objectives, MHPD focuses on:

• consulting with stakeholders early in the regulatory process in order to share information and encourage two-way dialogue, and improve benefit and risk assessments;
• developing an appropriate post-market surveillance framework and regulatory processes;
• targeting communications to "at risk" populations through multiple channels;
• leveraging and building on best practices from other countries.

Additional information on the roles, responsibilities, and programs of MHPD is available at www.healthcanada.gc.ca/medeffect