ISBN: 978-0-662-48757-9 (PDF Version)
Cat.: H164-2/2008E (PDF Version)
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
The Marketed Health Products Directorate (MHPD) monitors the safety, effectiveness, and quality of marketed health products in Canada including:
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:
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.
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:
Additional information on the roles, responsibilities, and programs of MHPD is available at www.healthcanada.gc.ca/medeffect
Did you know?
The MedEffect™ Canada Web site provides Canadians with centralized access to Health Canada's post-market surveillance programs, new safety information about health products, guidelines on how to report adverse reactions, and other key resources.