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Looking Ahead

2008
ISBN: 978-0-662-48768-5 (PDF VERSION)
Cat.: H164-86/2008E (PDF VERSION)

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The vision of the Marketed Health Products Directorate (MHPD) is to lead a post-market surveillance program that is at the forefront of regulatory science, promotes the safety and effectiveness of health products and is recognized internationally for its contributions to the health and safety of Canadians.

MHPD and the Health Products and Food Branch (HPFB) are committed to strengthening the post-market safety of marketed health products. Several documents describe this commitment in more detail, such as;

• 2007-2012 Federal Regulatory Post-Market Surveillance Strategy, which provides the overarching, strategic direction for MHPD over the next five years, and
• Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food, which outlines key strategic initiatives on the regulatory and policy side.

Guided by its 2007-2012 Strategic Plan, over the next five years MHPD will focus on partnering, being proactive, and reaching out through projects that:

• enhance information sharing among partners and stakeholders,
• increase international collaboration,
• render timely and transparent regulatory decisions, and
• increase public confidence while facilitating informed health product choices.

Modernization of the regulatory framework for pharmaceuticals and biologics

Through the modernization of the regulatory framework for pharmaceuticals and biologics, Health Canada will be developing - laws, regulations, and guidelines-that will support a life-cycle approach to the regulation of drugs. Manufacturers will continue to be required to provide information on the safety, quality and efficacy of a product prior to marketing but also throughout the life cycle of the product. The Branch will use this information to determine whether the product's benefits outweigh its risks and to make decisions about a product's continued sale in Canada.

This fundamental shift will improve Health Canada's effectiveness by helping the Branch to assess the safety, efficacy, and quality of products before, during, and after their introduction to the Canadian market. This will provide an increased body of knowledge, improved decision-making, and enhanced risk management and will create a system of drug regulation that supports the optimal use of drugs so that the benefits can be maximized and the risks minimized.

The work of MHPD to strengthen post-market surveillance will align with the principles of a product lifecycle approach.