Regulatory Focus™ > News Articles > Health Canada Releases Planned Overhaul of Vigilance System

Health Canada Releases Planned Overhaul of Vigilance System

Posted 13 September 2012 | By Alexander Gaffney, RAC 

Canadian healthcare regulators have released a new framework for conducting postmarketing vigilance activities on healthcare products, saying it is intended to "conceptually describe Canada's future integrated product vigilance system that will be developed over the next three to five years."

The framework, released 12 September, outlines what regulators at Health Canada are calling a "life cycle" approach to vigilance, which they said will help protect consumers and increase public confidence.

"Because of the increasing number and complexity of products used by Canadians to maintain and improve their health, it is important that Health Canada's product vigilance system remain open, transparent, accessible and accountable," Health Canada wrote. "Products available for sale in Canada have undergone a rigorous assessment and meet high standards of safety, quality and efficacy. The continued safe and effective use of these products depends on a thorough and ongoing understanding of the benefit-risk as they become known through real-world experience."

The framework currently under construction by Health Canada will eventually focus more of regulators' energies on higher-risk products through a prioritization process that aims to standardize a risk approach across numerous product lines. Importantly for industry, Health Canada said it will expect them to take on vigilance responsibilities, "consistent with international harmonization objectives wherever possible."

Specific Changes Proposed

The end goal, said regulators, was to set up a system characterized by its clarity, transparency, and consistency. The framework acknowledged the operation of regulators in an increasingly complex regulatory environment in which products are manufactured abroad and travel through a complex maze of overlapping supply chains. Once products are approved, it is the job of regulators and industry alike to make sure people remain safe when they use them. Increasingly, this involved the use of a proactive, as opposed to passive, vigilance system and cooperation between international regulatory bodies, industry, consumers, patient groups and safety-oriented organizations.

The framework also proposes two possible changes to Canada's legal framework for vigilance: requiring label changes based on new risk information and new measures to improve the transparency of vigilance data. Both changes would allow risk information to be made available to consumers more quickly and allow regulators to conduct a continuous postmarket assessment of products. This would result in a more effective and efficient system consistent with its overall goals, wrote Health Canada.

Several new projects are in the works to help regulators conduct product vigilance. The first, established by the Marketed Health Products Directorate (MHPD), will monitor adverse event reports data within Canada's Vigilance Database, "In the most comprehensive manner possible and that is comparable to international partners." This is set to include routine statistical analysis, increased communication between stakeholders and Health Canada, and targeted monitoring of riskier products, severe adverse events and specific sub-populations.

Broader Goals Established

On a broader level, new vigilance activities will take a step-wise approach, starting with higher-risk products. Regulators will first determine how best to monitor a product, monitor it, and then develop risk management activities tailored to each individual product's risks. The prioritization of resources based on risk will be key to this framework, said Health Canada, particularly due to limited regulatory resources. Thus, not all products will require a risk management plan, and many may never be moved to a state of enhanced monitoring based on their well-established safety profiles.

Seven guiding principles will form the basis of Health Canada's vigilance philosophy, it said: the adoption of a product lifecycle approach, the alignment of Health Canada to international best practices, the facilitation of compliance, alignment of activities to good governance principles, continuous improvement of monitoring activities, the maintenance of standards and cooperation with foreign regulatory bodies.


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