On December 3, 2010 Health Canada announced a consultation on the Health Product Vigilance Framework (“HPVF"). The purpose of the HPVF is to provide an overarching model for how the Health Products and Food Branch views health product vigilance and priorities for health product vigilance tools. Through the Health Product Vigilance Transformation Initiative, the Marketed Health Products Directorate aims to proactively improve health product vigilance by adopting a lifecycle approach.
Significantly, the HPVF not only describes the current vigilance framework in Canada but also conceptually describes Canada’s future integrated product vigilance system—a system that will be consistent with international best practices where possible. The goal behind the HPVF will also be to provide a coherent approach to product vigilance across product lines, to strengthen regulatory processes and to provide clarity and transparency around how Health Canada performs product vigilance (including the role of industry in product vigilance). The HPVF will be developed over the next three to five years.
The consultation is open for comment starting December 3, 2010 until December 17, 2010. The consultation document is available at: http://www.hc-sc.gc.ca/dhp-mps/consultation/medeff/_2010/hpvf-cvps/dhpvf-ecvps-eng.php.